A randomized intervention of physical activity promotion and patient self-monitoring in primary health care

Preventive Medicine 42 (2006) 40 – 46 www.elsevier.com/locate/ypmed

A randomized intervention of physical activity promotion and patient self-monitoring in primary health care Minna Aittasalo a,*, Seppo Miilunpalo b,c, Katriina Kukkonen-Harjula a, Matti Pasanen a a

The UKK Institute for Health Promotion Research, P.O. Box 30, FI-33501 Tampere, Finland b Kiipula Rehabilitation Centre, Turenki, Finland c School of Public Health, Tampere University, Finland Available online 16 November 2005

Abstract Objectives. To examine the effectiveness of prescription-based counseling and self-monitoring in the promotion of physical activity in primary health care. Methods. The study was conducted in Finland during 2003 – 2004. Physicians from 24 health care units (N = 67) were randomized to a prescription or a non-prescription group. The patients (N = 265) were assigned to the groups according to their physician. Every other patient of the non-prescription physicians received a pedometer and a physical activity log (MON) and feedback about their 5-day-recordings, the rest served as controls (CON). PA was assessed prior and 2 and 6 months after the physician’s appointment with a questionnaire. Results. The mean increase in weekly overall physical activity at 2 months was 1.0 (95% CI 0.0 to 2.0) session more in the prescription group than in controls. In at least moderate-intensity physical activity, the mean difference in changes was 0.8 (95% CI 0.1 to 1.5) sessions at 2 months and 0.9 (95% CI 0.2 to 1.5) sessions at 6 months for the favor of the prescription group. Compared to controls, self-monitoring increased the weekly duration of overall PA at 2 months on average by 217 min (95% CI 23 to 411). Conclusions. Prescription can be recommended as a tool for primary health care physicians to promote physical activity. Self-monitoring with an expert feedback can be useful in increasing especially the weekly duration of overall physical activity in the short term. D 2005 Elsevier Inc. All rights reserved. Keywords: Physical activity; Counseling; Physician; Effectiveness; Primary health care

Introduction There is increasing evidence about the benefits of physical activity (PA) in the prevention and treatment of major public health diseases [4,10,25,35]. Still, less than half of the adult population in most developed countries fulfills the recommendation of sufficient PA for purposes of health [25,37]. During the last decade, encouraging results about the effectiveness of physician-delivered counseling have been achieved to increase PA of sedentary persons [6,12,14,17,26, 30,32]. However, the effects seem to dilute in the long term, which is presumed to arise from the physicians’ inability to integrate the key components of counseling, such as control visits and cowork with other health staff, to the counseling procedure [34]. Self-monitoring has also been brought up as a * Corresponding author. Fax: +358 3 28 29 200. E-mail address: [email protected] (M. Aittasalo). 0091-7435/$ - see front matter D 2005 Elsevier Inc. All rights reserved. doi:10.1016/j.ypmed.2005.10.003

method for PA promotion especially after the development of accurate electronic pedometers [33]. Pedometers are easy to use, inexpensive and less time consuming than counseling based on conversation. The use of such devices can have a positive influence on PA at least in the short term [8,31,41]. This randomized controlled trial examines the feasibility and effectiveness of prescription-based PA counseling by physicians, ‘‘Prex’’ (Fig. 1), developed and piloted in Finland during 2001 –2002 [21]. To gain information about the effects of a less time consuming method, self-monitoring with a pedometer and PA log was also studied. Subjects and methods Recruitment of health care units and physicians Municipal primary health care centers (PHC) and occupational outpatient health care units (OHC), both private- and community-owned with more than four physicians and within the reach of less than 2-h traveling time from the

M. Aittasalo et al. / Preventive Medicine 42 (2006) 40 – 46

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Fig. 1. Prescription form, ‘‘Prex’’, developed in Finland for physician-based physical activity counseling and attached to the counseling procedure of the study. The study was conducted in 24 Finnish health care units in 2003 – 2004.

research center were contacted by phone (N = 34; 18 PHC and 16 OHC). The first contact was made with the chief physician, who was to recruit assisting staff (receptionists) and at least 4 voluntary physicians. During the 4-month recruitment period, altogether 8 PHC and 10 OHC agreed to participate (53%), totaling in 26 health care units because more than one unit participated from several PHCs. The most common reasons for refusal were an insufficient number of interested physicians, understaffing of physicians, no regular on-site registration of patients and too many developmental projects going on. Two OHC recruited the last were put in reserve in case of excessive drop-outs, and 24 units (67 physicians) signed a written agreement to participate. Eight units and about half of the physicians (N = 39) represented OHC. Separately in each unit, the physicians were randomized into either a prescription (PREX) or non-prescription-group (N-PREX).

Randomization was performed to diminish the selection bias of physicians less interested in counseling from being overrepresented in N-PREX.

Training of physicians and assisting staff The PREX physicians were trained for 2 h for the counseling procedure of ‘‘Prex’’. It was suggested that also other health care staff, such as physiotherapists and nurses, participated in the training. The key issues of counseling were: (1) patients’ prevailing PA, their readiness to increase PA and PA preferences, (2) patient-centered goal-setting, where also other than healthrelated goals were valued, (3) emphasis on lifestyle activities, which may have more long-term effects than structured exercise [11] and (4) agreement on control visits most preferably with a preset date. Evidence about the health benefits of PA was also presented. A ‘‘User’s guide’’ was provided to each

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trainee and they were to practice the use of ‘‘Prex’’ with two patients not participating in the study. At the same training visit, during a separate 1h session, the assisting staff (N = 54) was instructed. They were contacted regularly in the course of the study to encourage recruitment of 10 patients for each PREX physician and 15 for the N-PREX physician.

Study design The study was approved by the independent ethical committee of the UKK Institute for Health Promotion Research. The intervention period lasted from March to September 2003. All 20 – 65-year-old patients who made an appointment with the participating physicians were asked by the receptionist to come 10 min before their scheduled time to complete a screening questionnaire (Fig. 2). The inclusion criteria were 30 min of moderate-intensity PA on fewer than 4 days weekly and no perceived obstacles for PA. The baseline PA was determined with questions modified from the short version of the International Physical Activity Questionnaire (IPAQ) [7]. PA was defined as all daily PA excluding work. Patients returned the questionnaire to the receptionists, who checked the inclusion criteria and if fulfilled, obtained a written informed consent. The patient of a PREX physician went to the appointment with the screening

questionnaire, a copy of the consent and a ‘‘Prex’’, which was a sign for the physician to include counseling with ‘‘Prex’’ in the usual care. Patients of NPREX physicians received only the usual care. However, every other one of them was asked to see the receptionist after the appointment and was instructed to use a pedometer (DW 700 Yamax, Japan) and a PA log [3] for five consecutive days (MON). The patients received feedback by mail from a physiotherapist. The letter included personal PA recommendations for health in frequency, duration and intensity of PA sessions [35] as well as in number of daily steps [22,33,39]. The patients of the N-PREX physicians who did not participate in self-monitoring served as controls (CON). Follow-up questionnaires with the same PA questions as at baseline were sent 2 and 6 months after the physician’s appointment. At 2 months, questions about possible adverse affects caused by PA were included as well as questions about material received at the physician’s visit and possible control visits.

PA counseling The counseling proceeded according to the framework of 5 A’s [15]: Assessment of patients’ prevailing PA habits and possibilities and willingness to increase PA, Advice on sufficient PA regarding health and potential personal benefits of PA, Agreement on PA goals and a weekly PA plan, Assistance at

Fig. 2. Design and flow chart of the study conducted in Finland in 2003 – 2004. *) Physical activity; **) physiotherapist; 1) Usual care + prescription (‘‘Prex’’) -based physical activity (PA) counseling delivered by physicians; 2) Usual care + self-monitoring of PA with a pedometer and a PA log for 5 consequent days followed by mailed feedback and PA recommendations; 3) Usual care; appointments to physicians carried out as usual; control group.

M. Aittasalo et al. / Preventive Medicine 42 (2006) 40 – 46 identifying PA barriers and suitable exercise services and Arrangements for a control visit with a precise date including a possibility to use a PA log for selfmonitoring. To support cooperation with other health care and exercise workers, ‘‘Prex’’ could be used as a referral to physiotherapists, nurses or exercise experts.

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In self-monitoring (MON), the mean increase of weekly duration of overall PA at the 2-month follow-up was 217 min (95% CI 23 to 411) more than in CON. Feasibility

Effectiveness and process evaluation The indicators of effectiveness were changes in the frequency and duration of overall and at least moderate-intensity PA from the baseline to the 2- and 6-month follow-up. Feasibility was assessed by the number of ‘‘Prex’’ forms completed, a content analysis of 30 randomly selected ‘‘Prex’’ copies, the questions included in the patient follow-up questionnaires (adverse effects, material received, control visits) and telephone interviews conducted after the last follow-up with 15 randomly selected PREX physicians (‘‘Prex’’ form as counseling tool, applicability with different patients and appointments, time spent on counseling, future use, obstacles for non-usage) and patients (need for PA counseling and ‘‘Prex’’, applicability of the plan, factors enabling and restricting to follow the plan, perceived effect of ‘‘Prex’’, general utility of ‘‘Prex’’).

Statistical methods Descriptive group characteristics are given as means, standard deviations, standard errors and percentages. Between-group differences in changes were analyzed by analysis of covariance with two contrasts: PREX vs. CON and MON vs. CON. The covariates at baseline were PA, age, gender and the presence of chronic illnesses as a reason for the physician’s appointment. Before analysis, the missing values in data were replaced by a multiple imputation method because the drop-out rate especially at the 2-month followup was greater in CON (27%) than in PREX (17%) or MON (16%). Square root transformations were used to normalize the distribution of the duration of overall PA and of at least moderate-intensity PA. The imputation was performed by using Schafer’s NORM program (version 2.03 for Windows 95/98/NT). The number of imputed data sets was six. In analyzing the group differences in possible adverse effects and physicians’ control visit practices, the Chi-square test of independence was used.

Results After randomization and training, 6 physicians (2 PREX, 4 N-PREX) dropped out, and no patients were screened for 16 (7 PREX, 9 N-PREX) physicians (Fig. 2). Thus, patients were screened for 45 (74%) participating physicians. The questionnaire was completed by 992 patients and 535 (54%) of them were eligible for the study. Two hundred sixty-five (50%) of the eligible patients gave the written informed consent. Description of the participants and patients fulfilling the criteria but not giving the consent (N = 270) is in Table 1. Effectiveness After two reminders, 213 patients (80%) returned the 2month and 203 (77%) the 6-month follow-up questionnaire. PA at baseline and at both follow-ups is shown in Table 2. At the 2-month follow-up, the increase in the weekly number of overall PA sessions was on average 1.0 (95% CI 0.0 to 2.0) session and in at least moderate-intensity PA 0.8 (95% CI 0.1 to 1.5) sessions greater in PREX than in CON (Table 3). At the 6-month follow-up, the mean difference in changes between PREX and CON in at least moderate-intensity PA was 0.9 weekly sessions (95% CI 0.2 to 1.5) for the favor of PREX.

The average number of ‘‘Prex’’ per physician was 5: two physicians compiled only 1 and 11 physicians 5 – 10 prescriptions. No blank ‘‘Prex’’ forms were returned, suggesting that ‘‘Prex’’ had been delivered to all the patients intended. The content analysis of 30 ‘‘Prex’’ copies showed that PA habits had been assessed (100%), a PA goal had been set (78%) and a control visit had been agreed (87%). However, most of the goals were health-oriented (70%) and the average number of weekly PA sessions recommended (7.6) was quite high compared to patients’ prevailing sessions in ‘‘Prex’’ (3.7). In addition, 53% of the PA plans included only structured exercise and none of them were exclusively based on lifestyle activities. A control visit was in most cases the next physician’s visit (82%) but a preset date had been written down in only every other ‘‘Prex’’. Three physicians had used ‘‘Prex’’ as a referral to other health care staff or exercise experts. At the 2-month follow-up questionnaire, 24% of the respondents reported some adverse effects caused by PA, mostly musculoskeletal pains, but no statistically significant differences were found between the groups (Chi-square test). Those in PREX recalled having received written material during the physician’s appointment more often (N = 68) than those in MON (N = 16) or CON (N = 8). ‘‘Prex’’ was mentioned as the received material by 37 PREX, 2 MON and 1 CON respondents. No statistically significant group differences were found in the frequency of control visits to the physician. In the telephone interviews, most physicians reported ‘‘Prex’’ as an acceptable counseling tool, being most applicable for health check and control visits. Counseling with ‘‘Prex’’ took 5– 10 min in average, but 8 physicians would have preferred 15 min. Ten physicians believed using ‘‘Prex’’ in the future. Lack of time and difficulty of linking other health care workers to the counseling were the most frequently mentioned obstacles for usage. The majority (N = 13) of the interviewed patients reported that ‘‘Prex’’ served as a trigger to initiate PA. Nine patients felt that they would not have changed their PA habits without ‘‘Prex’’. The most common reasons for not carrying out ‘‘Prex’’ were lack of time and willpower. Factors encouraging to ‘‘Prex’’ included company, good feeling after PA, baby-sitter and good weather. All patients felt that ‘‘Prex’’ had been within their capabilities to carry out and all except one considered ‘‘Prex’’ as a worthwhile way of promoting PA in health care. Discussion This study showed that physician-delivered PA prescription was able to increase the weekly frequency of patients’ overall PA in short-term and at least moderate-intensity PA in both

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Table 1 Description of participants and those who fulfilled the inclusion criteria of being physically active on fewer than 4 days weekly and having no obstacles for physical activity (PA) but did not give the written informed consent to participate

Age (years) mean (SD) Proportion of females (%) Chronic illness (%) Chronic illness as a reason for appointment (%) Earlier discussions about PA with a physician within 6 months (%) 30 min of moderate-intensity PA (%) On 2 – 3 days weekly Once a week On 2 – 3 days monthly On fewer than 2 days monthly

PREXa (N = 130)

MONb (N = 62)

CONc (N = 73)

Participants (N = 265)

Patients fulfilling the criteria, no consent (N = 270)

46 (11) 75 85 52

44 (13) 77 89 44

48 (10) 77 85 37

47 (11) 76 86 46

45 (11) 65 71 37

32

38

32

33

37

49 25 17 9

55 29 14 2

60 24 8 8

54 25 14 7

68 21 7 4

The study was conducted in 24 Finnish health care units in 2003 – 2004. a Usual care + prescription (‘‘Prex’’) based physical activity (PA) counseling delivered by physicians. b Usual care + self-monitoring of PA with a pedometer and a PA log for 5 consequent days followed by mailed feedback and PA recommendations. c Usual care; appointments to physicians carried out as usual; control group.

short- and long-term. According to the interviewed physicians and patients, it was also a feasible way of promoting PA in primary health care. Self-monitoring of PA using a pedometer and a PA log increased weekly duration of overall PA in short-term. Several factors strengthen the value of our results: (1) ‘‘Prex’’ and self-monitoring had been piloted earlier [3,21], (2) the physicians and assisting staff undergone training, (3) the physicians were randomized into the study groups, (4) counseling was practiced before the intervention, (5) reliable, valid and simple PA measures were used, (6) process

evaluation was included in the analysis and (7) the dropout rate of patients at both 2- and 6-month follow-up was small. However, few problems arose during the study affecting the generalization of the results. First, the receptionists were not able to give the screening questionnaire to all the patients intended, which may have caused selection bias. Secondly, lack of time and staff holidays prolonged the recruitment period, which may have increased variation in PA due to seasonal reasons. Thirdly, the PA data were based on self-reports, which can be susceptible to over- or underreporting.

Table 2 Physical activity (PA) in the 3 study groups at baseline (0 month) and at the 2- and 6-month follow-up 0 month

Number of overall weekly PA sessions PREXc MONd CONe Number of at least moderate-intensity weekly PA sessions PREXc MONd CONe Duration of overall weekly PA (min) PREXc MONd CONe Duration of at least moderate-intensity weekly PA (min) PREXc MONd CONe

2 months

6 months N = 265

N = 198 – 203a

N = 265b

7.4 (0.3) 7.3 (0.4) 6.5 (0.5)

7.2 (0.3) 7.2 (0.4) 6.4 (0.5)

7.6 (0.3) 6.7 (0.4) 6.8 (0.5)

7.5 (0.3) 7.0 (0.4) 6.7 (0.5)

2.3 (0.2) 2.4 (0.2) 2.7 (0.2)

3.6 (0.2) 3.1 (0.2) 3.0 (0.3)

3.7 (0.2) 3.1 (0.2) 3.1 (0.3)

3.5 (0.2) 3.1 (0.3) 2.9 (0.3)

3.6 (0.2) 3.1 (0.2) 2.9 (0.3)

344 (29) 419 (65) 430 (82)

546 (59) 647 (81) 445 (54)

539 (53) 654 (76) 455 (54)

548 (45) 536 (70) 488 (53)

526 (43) 555 (66) 480 (54)

69 (5) 84 (7) 81 (6)

97 (7) 102 (11) 82 (7)

98 (7) 106 (12) 84 (8)

99 (8) 89 (7) 85 (8)

99 (8) 94 (9) 88 (8)

N = 265

N = 206 – 213

5.9 (0.3) 6.2 (0.4) 6.3 (0.4)

a

b

Means (SE). The study was conducted in 24 Finnish health care units in 2003 – 2004. a Data with complete cases at 2- and 6-month follow-ups. b Data with missing values replaced by multiple imputation. c Usual care + prescription (‘‘Prex’’) -based physical activity (PA) counseling delivered by physicians. d Usual care + self-monitoring of PA with a pedometer and a PA log for 5 consequent days followed by mailed feedback and PA recommendations. e Usual care; appointments to physicians carried out as usual; control group.

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Table 3 Group differences in physical activity (PA) changes from baseline to the 2- and 6-month follow-up compared to CON Change in PAa

Physical activity 2 months Group differences of changes Number of overall weekly PA sessions PREXb vs. CONc MONd vs. CON Number of at least moderate-intensity weekly PA sessions PREX vs. CON MON vs. CON Duration of overall weekly PA (min) PREX vs. CON MON vs. CON Duration of at least moderate-intensity weekly PA (min) PREX vs. CON MON vs. CON

6 months

95% CI

P

1.0 0.9

0.0 to 2.0 0.3 to 2.2

0.05 0.07

0.8 0.3

0.1 to 1.5 0.5 to 1.0

0.024 0.51

118 217

50 to 286 23 to 411

0.17 0.029

21 24

2 to 43 2 to 50

0.07 0.07

Group differences of changes

95% CI

P

1.1 0.5

0.1 to 2.2 0.7 to 1.7

0.07 0.43

0.9 0.4

0.2 to 1.5 0.4 to 1.1

0.023 0.33

79 79

28 to 186 46 to 205

0.15 0.22

16 6

6 to 37 20 to 31

0.15 0.67

Means, confidence intervals (95% CI) and statistical significance ( P) between the groups. The study was conducted in 24 Finnish health care units in 2003 – 2004. a Group differences adjusted for baseline; gender, age and chronic illness-related physician appointment as covariates in the analysis of covariance; missing values replaced by multiple imputation, yielding N = 265. b Usual care + prescription (‘‘Prex’’) -based physical activity (PA) counseling delivered by physicians. c Usual care; appointments to physicians carried out as usual; control group. d Usual care + self-monitoring of PA with a pedometer and a PA log for 5 consequent days followed by mailed feedback and PA recommendations.

The ‘‘Prex’’ can help patients to start increasing the frequency of weekly PA sessions. As some of the increase was maintained until the 6-month follow-up, also more permanent changes [9,23,24] seem possible. The high PA at baseline and large variation of PA may have diluted the actual changes, which makes otherwise moderate findings also clinically relevant. Findings about the effectiveness of selfmonitoring support earlier study results about the increase of PA in short term [8,31,41]. This should be taken into consideration when choosing assessment methods for PA counseling studies. The training given before the intervention seemed to succeed in transmitting the basic principles of ‘‘Prex’’ to the physicians. However, a more patient-centered approach with patient-initiated goals, PA plans with more lifestyle activity and a precise schedule for control visits seemed lacking. Also, as found in other studies [27,29], trained physicians did not use prescription as a referral to other health care workers more than untrained ones; nor seemed they agree more on control visits with their patients. However, here, the 2-month follow-up period may have been too short to discover differences in group practices because according to ‘‘Prex’’ copies most of the control visits were scheduled at 3 or 6 months. Nevertheless, as indicated in previous studies [29], it seems that a more comprehensive approach than a single training session is needed to facilitate physicians to patient-centeredness, cooperation and accurate control visit practice. In health care, this may require multi-professional team, which is responsible of planning the local practice and arranging mutual training and meetings [40]. The physicians reported ‘‘Prex’’ as an acceptable and applicable way of promoting PA and were satisfied with the structure of the form. Lack of time was reported as the most

common barrier for counseling as found also in other studies [1,2,13,18,19,38]. However, it may reflect also other known problems with physicians’ counseling, such as incompetence in counseling skills, PA knowledge and confidence in patients’ intentions to change their PA habits [1,2,5,18,38]. This is supported by the fact that, in Finland, physicians who counsel spend approximately 6 min on PA counseling during a 16-min appointment [20] and therefore, the average 5– 10 min spent in ‘‘Prex’’ would seem to fit well with the everyday practice. In a recent Dutch study [36], even 10– 14 min did not seem to be a primary barrier for PA counseling. This was explained by the long-lasting relationships between practitioners and patients. The patients found ‘‘Prex’’ as an acceptable and helpful way to promote PA at the physician’s appointment. This is consistent with earlier findings that patients prefer specific rather than general advice [16,29] and appreciate physician’s interest in lifestyle issues [28,29]. As a conclusion, ‘‘Prex’’ can be recommended as a tool for primary health care physicians to promote PA, especially at health check and control visits, where more time can be allocated for the appointment. A more comprehensive familiarization protocol than a single training session is needed to implement ‘‘Prex’’ to physicians’ everyday practices and facilitate counseling cooperation. Self-monitoring of PA with expert feedback can be a useful and cheaper way of increasing especially the duration of overall weekly PA in the short term. Acknowledgments We thank all the health care units who participated in the study, particularly the receptionists and physicians, for their

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efforts. Our acknowledgements are also due to the Finnish Ministry of Social Affairs and Health, and the foundations Juho Vainion Sa¨a¨tio¨ and Urheiluopistosa¨a¨tio¨ for financially supporting the study.

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