Randomized controlled evaluation of an education program for insulin treated patients with diabetes: Effects on psychosocial variables

Patient Education

and Counseling, 14 (19891191-215 Elsevier Scientific Publishers Ireland Ltd.

Randomized Controlled Evaluation of an Education Program for Insulin Treated Patients with Diabetes: Effects on Psychosocial Variables

Inge de Weerdt”, Adriaan Ph Visserb, Gerjo Kok” and Ed A. van der Veena ‘Department

Economics,

of Endocrinology, Free University Hospital, Amsterdam, bDepartment of Health University of Limburg, Maastricht and ‘Department of Health Education, University of Limburg, Maastricht (The Netherlundsl

(Received May 3rd, 19891 (Accepted July llth, 1989)

A multicenter controlled randomized education study was performed to evaluate an education program for insulin treated patients with diabetes. The main objective of the education program, which took place on an out-patient basis, was to improve the level of active self-care behavior of the participants. Fifteen randomly recruited hospitals (558 patients) were equally divided over three groups: two experimental groups who completed the program under the guidance of a health care professional (Al or a fellow patient (Bl, and a control group (Cl. Using the model of Fishbein and Ajzen as a theoretical guideline, the effect of the program on knowledge, diabetes locus of control, anxiety, attitude and social norm with respect to active self-care and level of active self-care behavior were assessed. Patients in the experimental group were evaluated four times, those in the control group twice with an intervening period of 617months. Compared to the control group, scores of both experimental groups on knowledge (P < 0.0011 and diabetes locus of control (P < 0.0011 improved significantly, but attitude, social norm and level of active self-care behavior improved only partially. Conclusion: the education program was only marginally effective in changing the active self-care behavior of the participants. Based on the results, recommendations for improvements to the education program have been formulated. Key words: diabetes education; evaluation: self-care behavior; Fishbein and Ajzen.

Introduction Much attention has been paid to the evaluation of diabetes education programs in the past decade. The results of these evaluation studies were very Correspondence to: Inge de Weerdt, Utrecht, The Netherlands.

Department

of Health Education,

0738-3991/89/$03.50 0 1989 Elsevier Scientific Publishers Published and Printed in Ireland

P.O. Box 5104, 3502 JC

Ireland Ltd.

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divergent and they offer no clues for improving future education programs [l]. Reasons for these very divergent results can be found in the poor study designs and the use of widely different assessment methods. Previously we proposed the development of a theoretical framework that can be used as a guideline to explain and to change the behavior of patients with diabetes and to evaluate diabetes education programs [l]. We started a multicenter education study in 1986. Its first objective was to establish a theoretical framework for the development and evaluation of diabetes education programs; secondly, it was intended to evaluate an existing education program for insulin treated patients with diabetes. In the first part of this study, the usefulness of the attitude-behavior model of Fishbein and Ajzen [2] in explaining active self-care behavior of insulin treated patients with diabetes was analyzed. The model of Fishbein and Ajzen (shown in Fig. 1) is based on the assumption that human behavior is reasoned behavior. This implies that a person’s intention is the immediate determinant of action. A person’s intention is a function of two basic determinants: attitude to behavior and social norm. In the theory of Fishbein and Ajzen, attitudes are a function of beliefs. A person who believes that performing a given behavior will lead to mostly positive outcomes will hold a favorable attitude towards performing the behavior, whereas a person who believes that this behavior will lead to mostly negative outcomes will hold an unfavorable attitude. The attitude consists of several relevant (or salient) beliefs (b) about whether the behavior will result in specific consequences (e.g., “Home blood glucose monitoring (HBGM) results in better metabolic control”) and the evaluations (e) of these consequences (“being in better metabolic control is good”). The attitude can be assessed by multiplying the beliefs by the corresponding evaluations, then adding up the products (Att = Xi bi x e,). A person’s social norm is his or her

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perception of whether the majority of significant others think that the person should or should not perform the behavior in question. The social norm is determined by several normative beliefs (nbl, which are perceived expectations of specific reference persons (e.g., “my partner wants me to perform HBGM”), and by the person’s motivation to comply (mc) with these expectations (e.g., “with regard to HBGM, I do what my partner wants me to do”). Just as the attitude, the social norm can be assessed by multiplying the normative beliefs by the motivations to comply, then adding up the products NV = Ii nbi x mc,). The model of Fishbein and Ajzen also considers external variables, such as personality characteristics and demographic variables. These external variables may influence all beliefs, evaluations, normative beliefs and motivations to comply a person holds or the relative importance he attaches to attitudinal and normative considerations. Previously published studies [l] showed that possibly relevant external variables for diabetes related health behavior are: knowledge; anxiety: diabetes locus of control; and demographic variables. Results from the first part of this study [3], the analysis of the usefulness of the model of Fishbein and Ajzen, showed that the model can provide valuable information to explain active self-care behavior of insulin treated patients with diabetes. Active self-care was considered to consist of four behavioral elements: home blood glucose monitoring regularly (HBGM), making self-devised adjustments of insulin dose, varying the timing and amount of meals to daily needs and taking exercise regularly. The model of Fishbein and Ajzen for the behavioral element ‘home blood glucose monitoring regularly’ that was constructed based on the results of the first part of this study, is given in Fig. 2. The figure shows that for home blood glucose monitoring, level of knowledge

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and powerful others health locus of control were important external variables. These external variables had a significant partial correlation with behavior. This implies that their influence on behavior was not completely mediated by attitude and social norm. Level of anxiety was not of significant value in explaining active self-care. Attitude and social norm were almost equally important for determining intention. There was a relatively low correlation between intention and behavior. This might be due to the negative partial correlation coefficient (correlation coefficient when correcting for the influence of attitude and intention) of social norm to behavior. It seems as if the environment had a positive influence on intention to HBGM, but that did not lead to the desired behavior. Attitude was therefore the most important variable in explaining HBGM regularly. A sufficient level of knowledge and a low orientation on the powerful others health locus of control-scale were found to be prerequisites for active self-care behavior. Similar results were found for the other three behavioral elements of active self-care. Only for taking exercise regularly, the external variables had no significant partial correlation with behavior: their influence was completely mediated by attitude and social norm. The second aim of our study was to evaluate the effect of an existing education program on the variables of the model of Fishbein and Ajzen and several outcome variables (metabolic control, costs of therapy and quality of life). By using the model of Fishbein and Ajzen as a guideline for this evaluation study, an explanation for the assessed effects can be found and suggestions for improvements to the education program under study and future education programs will become available. Here we describe the effects of the education program on knowledge, diabetes locus of control, anxiety, attitude and social norm with respect to active self-care and level of active self-care behavior. Subjects and methods The education program

The education program [4] was designed to instruct insulin treated patients with diabetes and to motivate them to active self-care. All relevant aspects of active self-care were discussed in order to give the patients plenty of opportunity to integrate diabetes in daily life as easily as possible. The program (on an out-patient basis) consisted of four weekly group sessions of 3 h. Ideally, each group was to contain ten patients. Each participant was allowed to be accompanied by someone, their partner or a good friend. The program itself consisted of a video film, a book and some practice materials. The program was highly structured. The video directed the course of each session: it provided the initial information and prompted participants to answer questions, read the book, taking part in group discussions and do their homework. In addition to being informative and directive, the video also had a motivational function. The film showed seven patients telling about their posi-

194

tive experiences with active self-care. These patients were chosen so as to form an average reflecting Dutch society. Each participant could recognize himself or herself in one of the people, and this could motivate them. The education sessions were led by a trained nurse, a dietitian or a patient with diabetes. Their task was to guide each session, to answer questions and to lead the group discussions. At the beginning of each session, the presence of a physician was required for discussing homework and answering specific and difficult medical questions. In this way the physician was also informed about the content of the education program. With respect to the content of the education program, the information given was in part aimed on influencing the attitude to active self-care of the participants. For HBGM, it was stated that the behavior will result in better metabolic control, improved awareness of glycemic control and more adequate adjustments of nutrition, insulin and exercise. With respect to self-devised adjustments of insulin dose, attention was only paid to the positive advantages of the behavior, i.e., the possibility to better regulate blood sugars and feeling better. Much attention was paid to improve the attitude to variation of nutrition by stressing the advantages of the behavioral element: having the possibility to eat everything, having more feelings of freedom, easier adjustments to many situations, having a more normal way of life and easier cooking. Only little attention was paid to the element taking exercise regularly. The education program only stressed the fact that the chance of a hypoglycemic reaction was increased. The education program scarcely aimed at improving the social norm on active self-care. Participants were allowed to bring someone, 50% of the participants did so. However, no attention was paid to the teaching of skills to manage the reactions from social environment. The education program was mainly aimed at improving knowledge and skills related to active self-care, and at convincing the patients that a good regulation of diabetes is mainly their own and not their physicians’ responsibility. More detailed information of the content of each session is given in Table I. Subjects

The study was conducted in 15 randomly selected hospitals spread geographically over the Netherlands. Ten hospitals served as experimentals (groups A and B), five hospitals were recruited as controls (group Cl. The division into one of the three study groups was random. All hospitals were of moderate size with a regional function. The experimental hospitals implemented the education progam after the pretest. In five experimental hospitals the education program was led by a health care worker from the hospital (group A); in the other five experimental hospitals, it was led by a fellow patient (group B). Before the study started, both the health care workers and the fellow patients attended the same leader training. Patients in group C were only tested and not given any extra education. Patients in all study groups were recruited in the same way. The physician of

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TABLE I SHORT OVERVIEW PROGRAM

OF THE CONTENT OF THE FOUR SESSIONS

OF THE EDUCATION

The program lasts for four sessions. Each session consists of: (al Introduction At the first session: introduction to the other participants; other sessions: discussing home(bl work with the physician (cl Watching the film (dl Answering the questions from the film Reading the book; some opportunity for group discussion (el Practice (fl A concluding video or group discussion (gl Each session comprises more than one video. Parts (cl, (dl and (el are repeated several times during each session. SESSION 1

Part 1‘“Balanced diabetes” This film is the introduction to the education program in which the narrator introduces the participating physician and nurse. They are responsible for the medical information and the explanation of the injection technique. Next seven patients with diabetes are introduced: they reflect a cross-section of Dutch society. A short overview of the education program is given. Part 2: “Why active self-care?” It is stated that a better balanced diabetes can be achieved by increasing one’s knowledge of diabetes and bringing the acquired knowledge into practice. The most important factor in balanced diabetes is the balance between insulin and nutrition. Part 8: “Diabetes mellitus” Following a schematic reproduction of the digestive tract, the conversion of food during the digestive process is explained. It is stated that diabetes therapy aims at blood glucose levels between 4 and 10 mmol/l by balancing nutrition and insulin. Part 4: %&in” Two kinds of insulin are distinguished: clear or short-acting insulin and troubled or intermediate acting insulin. The relationship with meals is explained for each kind of insulin. Part 5: “Injection technique” The point this film makes is that a proper injection technique is essential to achieve a good balance. The seven patients demonstrate their injection techniques and tell about their first injection. Practice: mixing two kinds of insulin. SESSION 2

Part 1: “Carbohydrates” The digestive tract is again demonstrated. Carbohydrates are divided into two different sorts: fast carbohydrates (conversion in 2-4 hl and slow carbohydrates (conversion in 4- 6 hl. Part 2: “Healthynutrition” It is important to pay extra attention to a good distribution of the carbohydrates during the day; the amount of carbohydrates must match the insulin taken and the daily activities. The seven patients explain how they deal with their diets in daily practice and how they vary their nutrition.

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TABLE 1 (continued) Part 3: “Home blood glucose monitoring (HBGM)” Home blood glucose monitoring is useful for two reasons: when a person feels uncertain and uncomfortable, information about the blood glucose level is needed. Both a patient and the nurse demonstrate the way they perform HBGM: a strip and a digital meter. In this part of the program the participants are motivated to perform HBGM themselves. Practice: HBGM. Part 4: “From HBGM to self-devised adjustments of insulin dose” A balance shows how to deal with disregulations on one side of the balance, insulin and on the other side, glucose. The patients tell of their experiences with impaired balance and how they coped with it. The day profile is introduced. SESSION 3 Part 1: “Hypoglycemia” The clinical signs of a hypoglycemic reaction are discussed. The patients tell about their own experiences. Efforts are made to reduce the fear of a hypoglycemic reaction. Part 2: “A severe hypoglycemic reaction” Some of the patients tell about their experiences with a severe hypoglycemic reaction: unconsciousness. The physician discusses the treatment of a severe hypoglycemic reaction: glucagon. Practice: exercises in the use of glucagon. Part 3: “A hyperglycemic reaction” The symptoms of a hyperglycemic reaction are compared with the onset period of diabetes. The causes of a hyperglycemic reaction are discussed, and two special occasions are highlighted: illness and stress. SESSION 4 Part 1: “Complications ” The stories of the seven patients indicate that most patients are frightened by long-term complications. The purpose of this film is to remove fear and ignorance of patients with diabetes and to motivate them to have regular medical examinations. Part 2: “Daily life ” This final film shows how theory works in practice. Each patient tells about personal solutions to several situations. The “experts” give their reactions to these stories: alcohol, eating, sweeteners, relaxation, exertion, exercise, etc. Consecutively: discussing daily life situations.

TABLE II THE NUMBER OF PATIENTS

IN EACH STUDY GROUP

Study group

Number of patients

Experimental: professional health care worker as leader (group A) Experimental: fellow patient as leader (group B) Control (group C)

183 172 203

Total

558

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each hospital randomly recruited 40-50 patients with diabetes by giving the first 40- 50 patients who came to the clinic a leaflet about the study and a request to participate. Criteria for inclusion were: age between 18 and 65 years; insulin dependency of over 6 months; not pregnant; and able to understand and speak the Dutch language. The participating diabetologists recruited 625 insulin treated patients, of whom 558 (89%) agreed to participate. The numbers of patients in each study group are shown in Table II. No significant differences were found between the three study groups as to age, educational level, duration of diabetes, insulin use, metabolic control, level of knowledge, attitude and social norm with respect to active self-care and level of active self-care behavior. The nonparticipating patients did not differ significantly as to age, gender, educational level, occupational status, duration of diabetes and insulin use. The most important reasons for not participating were lack of time, unreachable (moved, deceased1 and illness. Dropout rate at the end of the study was 7.5% (42 patients). The patients who dropped out did not differ significantly from the other participants as to age, gender, educational level, occupational status, metabolic control, level of knowledge and level of active self-care behavior. The most important reasons for dropping out were lack of time and lack of interest in the education program. The mean age of the participating patients was 44 years (S.D. = 15.3 years, range 18-65 years). Mean duration of diabetes was 12.7 years (S.D. = 9.6 years) and mean duration of insulin use 10.6 years (S.D. = 10.2 years). There was an equal distribution over both sexes. Study design

The patients in the experimental groups were evaluated four times: immediately before and after the education program, 1 month and 6 months after the education program. Patients in the control group were assessed twice with an intervening period of 6-7 months. The study design is schematically presented in Fig. 3. At each measurement the participants were asked to complete a questionnaire. In order to standardize the data collection as much as possible, patients

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were asked to come to the out-patient clinic of the local hospital in groups of 10-15. Immediate control of the completed questionnaire reduced the occurrence of missing data. Methods

A reliable questionnaire was designed to assess the external variables (level of knowledge, level of anxiety, diabetes locus of control1 and the variables of the model of Fishbein and Ajzen (attitude, social norm, intention and level of active self-care behavior). External variables Knowledge. Level of knowledge

was assessed using a multiple choice questionnaire consisting of 30 items covering general aspects of diabetes, home blood glucose monitoring, insulin, nutrition, exercise and long and short term complications. The questionnaire was designed using previously published questionnaires of Dunn [5], Casparie [6] and Visser [7]. Questions derived from the questionnaire of Dunn, were translated and adjusted to the Dutch situation. Using this method, content validity should be guaranteed. Questions covering urine control were replaced by questions about home blood glucose monitoring of Casparie [6] and Visser [7]. The first version of the developed knowledge scale was tested on comprehensibility at the out-patient clinic of the Free University Hospital in Amsterdam. Consecutively, 30 randomly recruited patients completed the second adjusted version of this knowledge scale, to test the difficulty and discrimination validity of each item. To test the reliability (construct validity), the next and final version of the questionnaire was completed by 55 randomly recruited insulin treated patients with diabetes. The questionnaire proved to be highly reliable (Cronbach’s a = 0.891. Indications for a high concurrent validity are a Pearson correlation coefficient of -0.36 between level of knowledge and age, and a correlation coefficient of 0.28 between knowledge and occupational status. These results correspond with the findings of Dunn and his analysis of the DKN-scales [5] and confirm our earlier findings that the developed questionnaire is reliable. Scores for level of knowledge could range from 0 (all answers wrong) to 30 (ail answers right). Anxiety. For level of anxiety, state anxiety was assessed by a validated Dutch version [8] of the Spielberger State Trait Anxiety Inventory [9]. Scores could range from 20 (low anxiety1 to 80 (high anxiety). Diabetes health locus of control. Diabetes health locus of control is a multidimensional construct, consisting of three dimensions: - Internal health locus of control (IHLC): the extent to which patients perceive their own behavior as responsible for their health or diabetic control - Powerful others health locus of control (PHLC): the extent to which patients perceive powerful relevant other people, e.g., the physician, as responsible for their diabetic control - Chance health locus of control (CHLC): the extent to which patients perceive chance factors (fate, luck) as responsible for their diabetic control. According to Halfens [lo] the predictive value of a disease specific health

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locus of control measure in patients with a specific disease, is higher than the predictive value of the general health locus of control measure. For this reason we applied the Dutch version [lo] of the health locus of control scale of Wallston and Wallston [ll] for diabetes. Each subscale consists of six statements that require a response to an agreedisagree, six-point Likert-type scale. A high score on each scale means a high orientation on the scale in question (ranges 6 - 361. To determine the multidimensional character of the developed questionnaire, factor analysis was performed. Principal factor analysis reported for the first three factors the following eigenvalues: 4.76, 2.48 and 1.04. Respectively, these factors explained 29.2,16.8 and 8.7% of variance. The results of the Varimax rotated factor analysis showed that the designed questionnaire consists of three main factors (IHLC, PHLC and CHLC) and that all items correlated highly to the right proposed factor. The reliability scores (Cronbach’s a) for the three subscales (IHLC a = 0.80, PHLC a = 0.84, CHLC a = 0.841 showed that each subscale had a high internal consistency. Results of both analyses combined gave sufficient evidence that a reliable questionnaire for assessing diabetes health locus of control was developed. Variables of Fishbein and Ajzen Attitude and social norm. Very explicit directives for the design of an appropriate questionnaire are available for studying the variables of the theory of Fishbein and Ajzen [2]. In accordance with these directives, 28 insulin treated patients with diabetes were interviewed or asked in an open questionnaire about four aspects of active self-care behavior: regular home blood glucose monitoring; adapting the size and timing of meals to daily needs; adapting the insulin dose to daily needs; and taking regular exercise. The aim was to elicit salient beliefs and salient normative beliefs about the four behavioral elements in order to construct a questionnaire. Then, in a pilot study, 50 patients were asked to complete this questionnaire to find the most important salient beliefs. This procedure resulted in 14 salient beliefs for variation of nutrition, 9 for exercise, 8 for and 8 for self-devised variations in the insulin dose. The salient beliefs for each behavioral element of active self-care are given in Table III. A corresponding number of evaluations for each behavioral element was included in the questionnaire. For each belief, we asked the patient to indicate the likelihood of certain consequences of a behavioral element. Scores ranged from 1 (very unlikely) to 5 (very likely). The evaluation of these consequences was indicated in terms of positive and negative scores from + 2 (very positive1 to - 2 (very negative). For each behavioral element, 9 normative beliefs and 9 motivations to comply were measured. The most important reference persons appeared to be the partner, house-mates, family, children, friends, physician, dietitian, colleagues and fellow patients with diabetes. An example of a question to measure the normative belief is: “does your partner think that you should perform HBGM regularly?’ Scores ranged from + 2 (yes, certainly) to - 2 (definitely not). For

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TABLE

III

THE SALIENT

BELIEFS

FOR THE FOUR BEHAVIORAL

ELEMENTS

OF ACTIVE

SELF-

CARE Home blood glucose monitoring

1 2 3 4 5 6 7 8

Better metabolic control More certainty Improved awareness of glycemic control More adequate adjustments of nutrititon More adequate adjustments of insulin More adequate adjustments of exercise Better communication with the physician More stress

Self-devised adjustments

1 2 3 4 5 6 7 8

of insulin dose

To control diabetes better To regulate blood sugars better More self-confidence Feeling better Being afraid of something Making mistakes Not having sufficient knowledge Something dangerous

Variation of nutrition

1 2 3 4 5 6 7 8 9 10 11 12 13 14

Having the possibility to eat everything Having more feelings of freedom More often performing blood tests Eating more tasty food Easier adjustments in many situations Eating the proper amount of carbohydrates Healthier eating habits Having a more normal way of life Having more dinner parties Easier cooking Gaining weight Being more often out of metabolic control Cheaper food Having less feelings of guilt

Taking regular exercise 1 More feelings of freedom

2 3 4 5 6 7 8 9

Feeling more fit Getting more satisfaction Better regulation of blood sugars Less having the idea to be sick Having a bigger chance of a hypoglycemic reaction Having more social contacts Receiving more understanding from social environment Not knowing how your body will react

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the motivation to comply patients were asked to indicate how much they cared about opinions of reference persons; scores ranged from very much (6) to not at all (0). Intention to behavior. The intention to behavior was measured for each behavioral element by one single question, e.g., “Do you intend to perform HBGM regularly in the near future?‘; scores ranged from + 2 (yes, certainly) to - 2 (definitely not). Level of active self-care behavior. Level of active self-care behavior was assessed by general questions about the frequency of the four behavioral elements of active self-care and a few questions to obtain more detailed information. A higher score means a higher level of active self-care behavior. Demographic variables. The questionnaire also covered relevant demographic data: age; gender; educational level (scale 1 (low) - 8 (high)); occupational status (scale 1 (low) - 5 (high)). Statistics

The statistical package for social sciences (SPSS) was used for the statistical analyses [12]. Analyses of variance (Anova, Oneway) were performed to analyze the differences between the scores on the first and fourth measurement of the experimental (0,-O,) and control groups (0,-O,) paired t-tests were used to investigate the differences between the four points of measurement (O,, 0,. O,, 0,) of the experimental group. To investigate for which subgroups of patients the education program was most effective, quartile and tertile grouping was performed, both for the experimental and for the control group, based on several scores (knowledge, locus of control, active self-care behavior, anxiety) of the first measurement. Analyses of variance were performed to compare the various subgroups. Results

The results with respect to the effect of the education program are presented for each behavioral element separately. First the effect on behavior is described. While the model of Fishbein and Ajzen ought to be able to account for changes in this behavior, secondly the effects on attitude, social norm and external variables are discussed. The results of the analyses of the usefulness of the model of Fishbein and Ajzen, as described in the introduction, are used for the explanation of the effects found. 1. Home blood glucose monitoring Effect

on behavior

Figure 4 shows the scores for frequency of HBGM of the experimental and control group at all measurements. Compared to the control group, frequency of HBGM increased significantly in both experimental groups (Ft2,451,= 3.84; P < 0.05).The main increase in frequency of HBGM appeared during the educa-

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The effect remained stable during the follow-up of the study. The scores of the control group did not change significantly. Percentual increase of frequency of HBGM for the entire experimental group was 29.5Oh. Most of this effect can be ascribed to those patients just starting with HBGM (F,, 416)= 7.93; P< 0.001). Apart from an improved frequency of HBGM, patients in both experimental groups also improved significantly on other aspects of behavior related to HBGM, such as carrying sugar u4;2505)= 4.01; P < 0.051, having glucagon at home (IL,, = 34.93; P < 0.0011, using short-acting insulin cFtzW5,= 6.01; P < 0.001) and keeping a record diary CF,,,,,, = 4.66; P < 0.01). In the experimental groups, the percentage of patients carrying sugar increased from 66.3 to 32.6%. At the end of the study, 54.3O/bof the patients reported that they had glucagon at home (before 16.6%) and the percentage of patients in the experimental groups who kept a record diary increased from 56.1 to 73.9%. The percentage of patients using short acting insulin almost doubled, from 24.6 to 45.5%. tion program.

Effects on attitude, social norm and external variables The effects on attitude and social norm with respect to HBGM are outlined in Table IV. Compared to the control group, the attitude to HBGM of both experimental groups improved significantly (P < 0.05). Most effect was found in experimental group B. T-tests were performed to find out which part of the

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0.45 0.03***

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0.35 - 0.49

5.53** - 1.31

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0.25 - 4.18***

- 1.071 - 0.77***

- 1.73 1.51

- 0.60** - 0.61

C mean

*Group A, experimental group with a health care professional as leader; group B, experimental group with a fellow patient as leader; group C, control group. *P < 0.001; +*P < 0.01; ***P < 0.05 (Oneway).

- 0.13 1.22***

6.41+ 5.55***

Attitude to variation of nutrition (n = 495) Social norm on variation of nutrition (n = 506)

Attitude to regular exercise (n = 485) Social norm on regular exercise (n = 514)

0.25 2.44

0.56** - 0.63

Attitude to HBGM (n = 499) Social norm to HBGM (n = 516)

Attitude to adjustments insulin (n = 477) Social norm on adjustments insulin bz = 511)

A mean

Study group

THE MEAN DIFFERENCES BETWEEN THE MEAN SCORES ON THE FIRST AND FOURTH MEASUREMENT ON ATTITUDE AND SOCIAL NORM WITH RESPECT TO ACTIVE SELF-CARE OF THE THREE STUDY GROUPS’

TABLE IV

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Fig. 5. Knowledge scores (mean and S.E.M.) of groups A, B and C on all measures (n = 513). Scores for level of knowledge could range from 0 (all answers wrong) to 30 (all answers right). Group A: experimental groups with a health care professional as leader. Group B: experimental group with a fellow patient as leader. Group C: control group.

attitude (beliefs or evaluations) caused the increased scores of the experimental groups on attitude to HBGM. All but one of the scores of the experimental groups on the evaluations did not change significantly. At the end of the study the evaluation of the belief in “improved awareness of glycemic control” was less positive Cp < 0.05). Most beliefs changed significantly. By the end of the study, the beliefs of the patients in the experimental groups that HBGM could result in a better metabolic control, improved awareness of glycemic control and more adequate adjustments of insulin, nutrition and exercise had increased (p < 0.001). The mean score on the belief “more stress” decreased @’< 0.001). Patients did not change their beliefs in “more certainty” and “better communication with the physician.” No effects of education were found on social norm (neither normative beliefs nor motivations to comply changed significantly) or intention. The positive effect of education on behavior might therefore be caused by the improved scores on the attitude to HBGM. According to the model of Fishbein and Ajzen, for HBGM outlined in Fig. 2, the improved scores on the attitude must have been established by changes in the scores on the external variables “level of knowledge” and “powerful others health locus of control.” Figure 5 shows the mean scores for level of knowledge of the experimental and control groups on all measures. Compared to the control group level of knowledge improved significantly in both experimental groups (Ft2,427,= 22.35; P < 0.001). The results show that level of knowledge rapidly increased during and shortly after the education program. The effect remained stable until 6

205

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groupc

Fig. 6. Scores (mean and S.E.M.) on the powerful others health locus of control scale of groups A, B and C on all measures (n = 511). Scores on the PHLC-scale could range from 6 (low orientation) to 36 (high orientation). Group A: experimental groups with a health care professional as leader. Group B: experimental group with a fellow patient as leader. Group C: control group.

months after the program. Percentual knowledge gain for the entire experimental group was 13.3%. The greatest gain in knowledge was found in patients of the experimental groups who enrolled in the study with a moderate level of knowledge (the second quartile: 41% improvement @‘c7,424) = 14.18; P < 0.0011, a high orientation on the powerful Others Health Locus of Control (PHLCl-scale (highest quartile: 23% improvement Wt,,386,= 4.33; P < 0.00111 and a low level of active self-care behavior with respect to self-devised adjustments of insulin dose (lowest tertile: 15% increase ui;5426, = 6.60; P < 0.00111 and home glucose monitoring (lowest quartile: 24% increase (Ft7,424)= 4.99; P < 0.001). The mean scores on the powerful Others Health Locus of Control (PHLCJ-scale of the experimental and control groups on all measures are shown in Fig. 6. Compared to the control group, the mean scores on the PHLCscale decreased significantly in the two experimental groups ui;2,435,= 7.12; P < 0.0011. At the end of the study, patients in the experimental group perceived the physician as less responsible for their diabetes control compared to before the education program. The mean score of the control group decreased slightly, but not significantly compared to the experimental group. Percentual decrease on the PHLC-scale of the entire experimental group was 10.3%. The greatest effect was found in experimental group B and in those patients with a high initial score on the PHLC-scale (two highest quartiles: 200/b decrease (F,,,,,, = 12.63; P < 0.00111.No effects of the education program were found on the IHLCscale and the CHLC-scale.

206

In spite of the fact that the results of the analysis of the usefulness of the model of Fishbein and Ajzen for explaining active self-care behavior, indicated that level of anxiety was not of significant value in explaining active self-care, the effect of the education program on this variable was assessed as well. No significant change in level of anxiety was found in any of the study groups. Mean level of state anxiety at the first measurement was 37.85 (S.E.M. 0.481. This corresponds with the results found in other studies investigating stateanxiety in patients with diabetes [13,14]. Surveying the effects found, the improvement in the scores on the attitude to HBGM can be explained by the improved scores on the external variables “level of knowledge” and “powerful others health locus of control.” The improved attitude to HBGM caused an improved level of behavior related to HBGM. Since the influence of the external variables was not completely mediated by attitude and social norm, the effect on behavior will in part be established by the improved scores for level of knowledge and PHLC. 2. Self-devised Effects

adjustments

of insulin dose

on behavior

Compared to the control group the mean scores of both experimental groups on the frequency of self-devised adjustments of insulin dose generally improved significantly (F,,,*,,, = 6.36; P < 0.011 (Fig. 71. The mean scores for frequency of

_____---

I

I

I

1

I

2

3

4

5

6

7

months -e

groupB

.-.*..

groupc

Fig. 7. Scores (mean and S.E.M.) on frequency of self-devised adjustments of insulin dose. Scores were categorized as: 0 (never), 1 (sometimes), 2 (often). Group A: experimental groups with a health care professional as leader. Group B: experimental group with a fellow patient as leader. Group C: control group.

207

self-devised adjustments of insulin dose of the control group did not change at all, while the scores of both experimental groups improved significantly. This effect emerged very gradually. Total increase in frequency of the behavior for the entire experimental group was 40%. Compared to the control group, patients of the experimental group adjusted their insulin dose more during holidays @&01, = 3.33; P < 0.051 and when they judged their blood glucose levels were too low or too high, based on clinical symptoms or home blood glucose monitoring (Fe510) = 6.31; P < 0.0011. The greatest increase in frequency of selfdevised adjustments of insulin dose was found in patients who had reported before the education program, that they never adjusted their insulin doses W ,5,50,,= 35.64;P < 0.001). Effects on attitude, social norm and external variables No significant effects of education could be found on attitude, social norm and intention with respect to self-devised adjustments of insulin dose at any point of measurement (Table III). For the social norm, no significant changes in normative beliefs or motivations to comply could be found. The lack of effect on the attitude was due to the neutralizing effects of changes in evaluations and beliefs. At the end of the study, patients in the experimental group believed more than previously, that self-devised adjustments of insulin dose could result in better control and regulation of their diabetes (P < 0.051. They also believed that they would have sufficient knowledge to perform this behavior, that they would make fewer mistakes and they perceived the behavior as less dangerous and frightening. However, at the end of the study, the same patients evaluated their positive beliefs less positively and their negative beliefs more negatively and thus neutralizing any effect. The total score for attitude to self-devised adjustments of insulin dose therefore remained unchanged. Since attitude and social norm ivith respect to self-devised adjustments of insulin dose did not change significantly, the improved scores for the frequency of the behavior of the experimental groups must therefore be established by the improved scores on the external variables. Previously we described the results for level of knowledge and powerful others health locus of control. Scores of the patients of the experimental groups for both variables improved significantly. The direct influence of these external variables on behavior, can explain the effect on behavior found. However, the improved scores of the external variables did not affect the attitude or social norm with respect to self-devised adjustments of insulin dose. 3. Variation of nutm’tion Effect on behavior No effect of education was found on the behavior related to variation of nutrition at any point of measurement. This includes the effect on the frequency of the behavior and, more specifically, also the effect on the flexibility in eating times and in amounts and kinds of foods consumed.

208

Effect

on attitude, social norm and external

variables

A positive effect of education could be found on attitude and social norm with respect to variation of nutrition (Table III). These effects appeared during the education program and remained stable during the follow-up of the study. Compared to the control group, the mean scores on attitude to variation of nutrition improved significantly in both experimental groups (Table III). Analyses of the changes in scores of the experimental groups on the evaluations and beliefs showed that the mean scores on most of the evaluations remained unchanged. Only the mean scores on the evaluations of “the possibility to eat everything”, ”having more dinner parties” and “cheaper food” were increased significantly P < 0.001). The mean scores on 6 out of 14 salient beliefs changed significantly. At the end of the study patients in the experimental group believed more that variation of nutrition could result in the possibility to eat everything, eating the proper amount of carbohydrates, healthier eating habits, having a more normal way of life and easier cooking P < 0.01). They believed less that more variation of nutrition could result in gaining weight (P < 0.011. Mean scores on social norm with respect to variation of nutrition for both experimental groups were increased significantly, but the greatest effect was found in group A (Table III). The change in mean scores on the social norm of the experimental groups was due to changes in normative beliefs and motivations to comply. Most of the scores on the normative beliefs increased slightly, while most of the scores on the motivations to comply decreased. The increased scores on the normative beliefs showed a more positive perceived opinion of the social environment to variation of nutrition, but the decreased scores on the motivations to comply showed that most patients were less concerned about these perceived opinions. Despite these neutralizing effects, scores on social norm increased for both experimental groups. No effect of education was found on intention to variation of nutrition. Despite improvements in the scores of the experimental groups on attitude and social norm with respect to variation of nutrition, no effect of education was found on the corresponding behavior. This might be due to the negative partial correlation coefficient of social norm to behavior. The increased positive influence of the attitude on behavior was neutralized by the increased negative influence of social norm on behavior. The improvement in the scores of the external variables “level of knowledge” and “powerful others health locus of control” did not affect the attitude, the social norm or behavior, despite the direct influence of these variables on behavior. 4. Regular Effect

exem’se

on behavior

No significant

effect of education could be found on the scores for regular exercise at any point of measurement. Although scores for all groups decreased slightly, there were no significant differences between them.

209

Effect on attitude, social norm and external variables The attitude to regular exercise showed no significant change in any of the groups at any point of measurement. Neither the evaluations nor the beliefs changed significantly. A significant effect of education could be found on the social norm with respect to regular exercise (Table III). Mean scores for the social norm in the experimental group improved (group A1 or remained stable (group Bl, while the mean scores in the control group decreased. For the social norm changes were found in normative beliefs and motivations to comply. Most scores on the motivations to comply decreased, while scores on the normative beliefs increased. Despite this neutralizing effect, the mean score on social norm with respect to regular exercise for group A increased somewhat. This was due to larger changes in the normative beliefs than in the motivations to comply. Changes in intention to regular exercise did not differ between the three study groups. Despite the improved scores of the experimental groups on the social norm, no effect of education on behavior was found. The external variables for regular exercise (level of knowledge and powerful others health locus of control) had no significant partial correlation with behavior. Their influence was completely mediated by the attitude and social norm and the increased scores on the external variables therefore did not affect behavior. The increased scores on the external variables only affected the social norm marginally. These small changes were not sufficient to cause a change in behavior. Conclusions and discussion The main objective of the education program under study, improving the level of active self-care behavior, was only partially achieved. The level of active self-care behavior related to HBGM and self-devised adjustments of insulin dose improved, but behavior related to variation of nutrition and regular exercise remained unchanged. Other studies investigating the effect of education on behavior seem to show some evidence for a positive effect of education on self-care skills and behavior [16- l&21 - 231. But their descriptions of the methods show that only passive self-care behavior was assessed: the results are therefore not comparable. According to the model of Fishbein and Ajzen, the main determinants of behavior are attitude and social norm. To improve behavior, improvements in attitude and social norm are necessary. Because of a negative partial correlation of social norm with behavior, increased scores on the social norm will have a negative impact on behavior, which can neutralize the effects of improvements in the scores on attitude or external variables. Attitude to active self-care was scarcely influenced by the education program. Only attitude to HBGM improved substantially. The small improvement in attitude to variation of nutrition was neutralized by the increased scores on the social norm. Changes in behavior were mainly due to changes in the external variables: level of knowledge and powerful others diabetes locus of control. The high partial correlation coefficient of the external variables to behavior show that 210

these variables have a direct influence on behavior and that their influence is not completely mediated by attitude and social norm. In fact, the improved scores for the external variables affected scarcely the attitude and the social norm. The education program significantly improved the level of knowledge of the participants. Other randomized controlled evaluation studies have also shown that diabetes education can improve knowledge [15-221. The education program also improved (decreased) the scores on the PHLC-scale of diabetes locus of control. Apparently the education program was able to convince the participants that their physician’s responsibility for the control of their diabetes is limited. However, no changes in the scores on the IHLC-scale were found. Because other studies did not investigate the effect of diabetes education on this variable, it is not possible to compare them with their results on this point. In spite of the fact that level of anxiety was found to be not of significant value for explaining active self-care, the effect of the education program on this variable was assessed. The program was not able to lower the level of anxiety. This could be due to the relatively short duration of the program. One study reported a lower level of anxiety after an intensive education program [23]. Surveying the effects found, the education program was only partially successful in improving the level of active self-care behavior. Only two out of four behavioral elements were improved. This is mainly due to a lack of effect of education on attitude to active self-care and its marginal effects on knowledge (only 13.3% change1 and PHLC (only 10.3% change). However, larger effects were found in specific subgroups of the study. The program would seem most suitable for patients with a moderate level of knowledge, a high orientation on the PHLC-scale and a low level of active self-care behavior. Another important attendant factor for the disappointing effect was the conflicting influence of social norm. This conflicting influence was mainly caused by the subjectively perceived negative opinion of the social environment on active self-care. Because of this negative opinion, patients felt some obstruction to perform this behavior. Other suggestions for this direction can be found in the fact that the participants in the education program reported that they had not learnt how to cope with reactions from the social environment. More actively educating the social environment in its broadest context seems necessary, and patients should be taught skills to manage such pressure. No salient significant differences were found between the two experimental groups. Both leader types, the health care provider and the fellow diabetes patient were equally effective. Some discussion is possible about the fact that the experimental groups were evaluated four times and the control group only two times. Whereas we have not assessed the effect of the extra measurements, we do not know whether we have introduced any bias. Practically, it was thought to be impossible to evaluate the control group four times as well, whereas the dropout rate in this group would be largely increased. We feel therefore that this was the best way to evaluate the education program. In this article no attention has been paid to the influence of health care 211

workers related factors (including organizational aspects) on the effectiveness of the education program. These factors might be of great importance. A formative evaluation will investigate these aspects. The results will become available in the near future. Conclusion: The education program in its present form, regardless of its leader, is only partially effective and only suitable for specific groups of patients. Improvements to the education program therefore seem necessary. Implications for the education program The education program is most suitable for patients with a low level of knowledge, a high orientation on the PHLC-scale and a low level of active selfcare behavior. However, for this specific group improvements to the education program are recommended as well. Basically the program failed to improve the internal health locus of control, attitude and social norm. To improve the internal health locus of control, more intensive and more personal education will be required. More intensive group discussions could be part of this. The exchange of experiences with fellow patients can be of great support [13,24] and might also lower the level of anxiety [13]. Group discussions were a marginal part of the education program and because of the tight schedule, time for more extensive discussion was not available. Lengthening the program and making more room for group discussions is therefore highly recommended. To improve the attitude and the social norm, the content of the program should be adapted. In its present form the education program is more aimed on the teaching of skills instead of influencing the attitude and social norm. As mentioned in the introduction, attitude consists of several beliefs about consequences of behavior and the evaluation of these consequences. Since the evaluation of consequences is a personal and quite unchangeable part of attitude, education should aim to change the beliefs. Below is a brief description of what beliefs of each behavioral element should be influenced. Attitude to HBGM was improved significantly by a change in the beliefs “improved awareness of glycemic control ”, “better metabolic control”, “more adequate adjustments of insulin, nutrition and exercise” and “more stress.” Although the education program paid attention to these beliefs, insufficient attention was given to the beliefs in “more certainty” and “better communication with the physician. ” For more effect on the attitude to HBGM, the education program should stress these beliefs as well. Since no effect of education was found on attitude to self-devised adjustments of insulin dose, the education program should give more emphasis to stress all relevant beliefs of this attitude. Only marginal changes in these beliefs were found. The education participants that program should therefore focus more on convincing performing this behavior will result in better metabolic control and better regulation of their diabetes. The program should also stress the fact that they will have sufficient knowledge to perform this behavior and that they will not make dangerous mistakes and that the behavior is not frightening or dangerous. The latter beliefs are also highly related to the self-confidence of the patients! 212

Attitude to variation of nutrition improved substantially. No adjustments to this part of the program are necessary. Attitude to regular exercise did not change at all. This is not surprising, since the education program paid scarcely any attention to this behavioral element. The content of the program should therefore be adjusted, and should stress the fact that more regular exercise results in a greater feeling of freedom, more satisfaction, better regulation of blood glucose levels, more social contacts, a better physical condition and lessened feelings of being ill. The program should also stress the fact that more exercise does not have to result in a greater chance of hypoglycemic reactions or other unexpected physical reactions. Improving the social norm will not always have a positive effect on behavior. The negative attitude of the social environment forms an obstacle to more active self-care for the patient with diabetes. The education program should pay more attention to this aspect. Teaching skills to manage this pressure is highly recommended, and this aspect should also be part of the group discussions. The social environment itself should become more familiar with new developments in diabetes care. In part this can be attained by involving the most important persons in the education program. But for the education of the ‘broader’ social environment the use of mass media is required. The same recommendations apply for more effect in groups other than the specific groups described. However, since these patients have a reasonable level of knowledge and a reasonable level of active self-care behavior, emphasis should be somewhat shifted to the group discussions and to the teaching of social management skills. The recommendations described are the result of an extensive evaluation of the education program. It is expected that this education program or future education programs will be more effective when they are adjusted or developed in accordance with these recommendations. Acknowledgments

We would like to thank P.J. Uitewaal, 0. de Weerdt, I. Visser, M.G. Leijdekker, T. Spinder. J.J. Spijkstra and R.B. Rexwinkel for their enormous support in gathering and processing the data. We also would like to thank the physicians and leaders of the program in the 15 participating hospitals: J.H.M. Hoskam, Diaconessenhuis, Breda; G. Zevenbergen, Algemeen Streekziekenhuis West-Friesland, Hoorn; W. Numan, Nije Smellinghe, Drachten; H.G.J. Houben, St. Joseph Ziekenhuis, Kerkrade; W.G.M. Bos, Gelderse Vallei, Bennekom; L.G. van Doorn, Mariaziekenhuis, Tilburg; M.P. Leemhuis, M. Lenis, Medisch Centrum Leeuwarden, Leeuwarden; R.P. Verhoeven, C. Hemmes, Julianaziekenhuis, Apeldoorn; R.E. Nikkels, J.C.J. Nikkels-de Bosch Kemper, De Wever Ziekenhuis, Heerlen; W. Bronswijk, M.C. Legdeur, T. Erkelens, J. Wieling, Medisch Centrum Alkmaar, Alkmaar; W.A.J.J. Bogers, A. Roestenberg, A. van de Boom, St. Nicolaas Ziekenhuis, Waalwijk; 0, de Wit, L. van de Vegt, A. Hartmann-Elzer, H. van de Berg, De Tjongerschans, Heerenveen; H.J. Lamers, J. Hoppenbrouwer, M.D. Ijssels, A. van de Ent-Snikkers, De Ma1berglE.G.. Arnhem; R.J.M. van Leendert, H.J. Heijwegen, Maaslandziekenhuis, Geleen; M.J. van der Horn, M. Verheij, Zeewegziekenhuis, Ijmuiden. We are very grateful for the financial support of Diabetes Research Fonds Nederland (The Dutch Diabetes Research Foundation).

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