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Poor adherence to self-medication instructions in children with asthma and their parents
Patient Education and Counseling 55 (2004) 416–421 www.elsevier.com/locate/pateducou
Poor adherence to self-medication instructions in children with asthma and their parents$ Vivian T. Collanda,d,*, Liesbeth E.M. van Essen-Zandvlieta,b, Caroline Lansa, Anne Denteneera, Paul Westersc, Hein J.L. Brackelb a
Asthma Centre Heideheuvel Soestdijkerstraatweg 1291213 VX Hilversum The Netherlands Department of Paediatric Pulmonology, University Medical Centre Utrecht/Wilhelmina Children’s Hospital, Utrecht, The Netherlands c Centre for Biostatistics, Utrecht University, The Netherlands d Department of Health Psychology, Utrecht University, The Netherlands
b
Received 7 May 2002; received in revised form 20 March 2003; accepted 13 April 2003
Abstract This study describes a self-treatment program for parents of children with asthma. The aim was to prevent asthma exacerbations by learning to recognise prodromal signs and acting upon them by increasing inhaled corticosteroids (ICS). The study questions were: (1) can we teach parents and children to recognise prodromal signs? (2) are instructions to increase inhalation medication followed? (3) will frequency and severity of asthma attacks diminish subsequently? Due to physicians’ changed attitude towards prescription of ICS, fewer children could be recruited who were ‘‘ICS-naı¨ve’’ than expected. Twenty-nine children of the age of 4–11 years with moderate asthma, participated in a one year prospective randomised study. Structured information was given to all patients on asthma, symptoms and medication. The experimental group received additional information on recognising prodromal signs and doubling ICS during one week. Only in 25% of the patients who recognised prodromal signs the dose of ICS was doubled (as prescribed), in 75% inadequately or not at all. Recognition of prodromal signs was poor as well as compliance to increase as-needed medication. No significant decrease of asthma symptoms occurred in the experimental group. Clinical implications are important for self-treatment instructions: an individually tailored and multi-component program should be offered by health care providers in order to help the patient to recognise early alarm symptoms, comply to self-treatment instructions and to make adaptations for continuous self-regulation. # 2004 Elsevier Ireland Ltd. All rights reserved. Keywords: Asthma; Child; Self-regulation; Compliance; Asthma-management
1. Introduction Asthma in childhood is characterised by short periods of wheezing, tightness of airways, feeling of dispnoe and tiredness, caused by a chronic airway inflammation. Allergens, weather changes, smoke, exercise and stress may all cause symptoms in the child with asthma. Often asthma symptoms cause problems to children and their $ This study was partly sponsored by a grant from the Netherlands Asthma Foundation (grant 94.31). * Corresponding author. Tel.: +31 356 881411; fax: +31 356 881499. E-mail address: [email protected] (V.T. Colland).
parents in daily life as it influences sleep at night, social and emotional development, functioning at school, and physical daily activities [1,2]. Beliefs and behaviours of patients with asthma have been shown to influence their adherence to preventive medication regimes and to asthma management [3–5]. For children with moderate to severe asthma, treatment consists of daily maintenance medication with inhaled corticosteroids (ICS) [6,7]. Intervention at early symptoms seems to be beneficial for long term prognosis [8,9] although randomised prospective studies in children are lacking. Many physicians advise to double the dose of ICS in a period of more symptoms, as part of an asthma selftreatment plan [6]. Parents are told to double the dose of ICS
0738-3991/$ – see front matter # 2004 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.pec.2003.04.010
V.T. Colland et al. / Patient Education and Counseling 55 (2004) 416–421
when they recognise the very first symptoms of an impending asthma period (so called ‘prodromal signs’), in order to prevent an asthma attack or worsening of symptoms [7–11]. Very few prospective studies on the effect of doubling ICS in steroid-naive children had been done at the start of this project. Only one study [9] investigated the effect of increasing inhaled corticosteroids at the first signs of exacerbations in children with asthma aged 1–14 years. This study [9] found that the most important determinant of the effect of the self-treatment plan was the amount of compliance to the self-medication regime. More studies are needed to investigate the effect of doubling the dose of ICS in children with asthma. This was one of the aims of our study. New in this study is our adding of a structured interview to help patients recognise prodromal signs and to teach how to act upon them. In this study, we investigated three questions related to a self-treatment plan: (a) is it feasible to teach patients to recognise prodromal signs?, (b) will patients comply with instructions to act upon first symptoms by doubling the amount of ICS during one week?, and (c) what is the effect of doubling ICS on the frequency and severity of asthma exacerbations?
2. Materials and methods 2.1. Patients Children with moderate asthma according to the American Thoracic Society criteria [12] were eligible for the study when they met the following inclusion criteria: age above 4, ability to perform reproducible lung function tests, (inhaled) corticosteroid-naive and an indication for starting maintenance treatment with ICS, (for parents and child) ability to speak and understand Dutch adequately. Twentynine children (19 boys, 10 girls), 4–11 years of age, were recruited from the outpatient paediatric clinics of Asthma Centre ‘Heideheuvel’ in Hilversum, and the University Medical Centre Utrecht, Department ‘Wilhelmina Children’s Hospital’, both in the Netherlands. The study was approved by the medical ethical committees of both hospitals and all parents gave their written informed consent. 2.2. Study design and method The study was a single blind prospective randomised study during one year. In the two-week run-in period only inhaled beta-2-agonists on demand were allowed. Randomisation was performed by an independent secretary in one of the hospitals, with stratification by centre and age. All patients were prescribed daily maintenance medication with a dose of 400 mg beclomethasone dipropionate or budesonide or 200–250 mg fluticasone propionate, divided over two doses. Most children received the medication by a spacer, some as dry powder formula.
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2.3. The program In both groups, children and parents received individual structured information from the paediatrician about asthma, symptoms, preventive measures, medication and asthma exacerbations during 2 one-hour sessions. The children and parents in the experimental group received additional information about individual prodromal signs, which were (if possible) identified together with the parents (for example, changes in child’s looks, behaviour, emotions, abdominal pain, cough, wheezing, fatigue, running nose or restless sleep). Patients in the experimental group were advised to double the daily dose of ICS for one week when these signs occurred. Patients were seen every 2 months at the out-patient clinic during one year including height and weight measurement. Throughout the study period all patients kept diary cards on which they registered peak flow (PF), medication and symptoms (the experimental group registered prodromal signs as well). Morning and evening PF were performed on a Personal Best Peak Flow Meter (Respironics, NJ, USA) and registered. PF measurements were used as day-to-day monitor for asthma exacerbations, including need of additional bronchodilatory therapy. Absence or presence of asthma symptoms, disabilities by asthma, absence from school and absence from work by the parent because of asthma of the child were registered daily on diary cards throughout the whole study. At each visit the doctor and parent (and child, when old enough) discussed the diary card, and how symptom perception and/or decrease of PF had been used to take additional medication. In the experimental group, maximal attention was focussed on recognition of prodromal signs and adjusting the dose of ICS immediately when parents recognised these signs. When they had not increased the dose of ICS, the reason why was discussed, and they were reinforced again to increase the dose at the very first prodromal sign. Inhalation technique and PF technique were checked at every visit. Primary outcome measures were the rate and severity of asthma attacks, frequency of disabilities, absence from school and parental absence from work due of asthma, registration of prodromal signs and compliance to selftreatment instructions (only in the experimental group). Secondary outcome measures were lung function expressed as forced expiratory volume in 1 s (FEV1) and bronchial responsiveness expressed as provocative dose of methacholine which causes a fall of 20% in FEV1 (PD20 FEV1 methacholine). 2.4. Lung function measurements At the start and the end of the study, lung function including reversibility and bronchial responsiveness to methacholine was measured. Before entry into the study, allergy was tested by RAST on house dust mite, cat, dog and grass pollen. A mild asthma exacerbation was defined as a
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period of at least 2 days with asthma symptoms for which broncho- dilatory medication was used. When in the middle of a period with bronchodilatory use one day no bronchodilator was used, the period was counted as one exacerbation; when on two or more days no bronchodilator was used, exacerbations were counted separately. An exacerbation was defined as severe if a course of prednisolone was prescribed. Patients were withdrawn from the study if it was not ethical to continue the study treatment according to the investigator, or if patients or parents wanted to stop. The time of measurement was between 8.30 and 16.00 h and for each patient constant throughout the study. Tests were only performed when no inhaled bronchodilator had been used during at least 8 h. No lung function measurements were done within the 4-week period after a course of prednisolone. FEV1 was derived from maximal forced expiratory flow-volume curves (Masterlab Body; Jaeger) and expressed as percentage predicted using reference values from Zapletal et al. [13]. Postbronchodilator FEV1 was measured 20 min after inhalation of 0.4 mg salbutamol administered by a volumatic spacer (Glaxo Wellcome, Greenford, UK) as 2 puffs of 0.2 mg. Reversibility tests were performed at the start of the study and at the 10-month visit. Bronchial responsiveness to methacholine was measured at the start and end of the study, using the dosimeter method described by Duiverman et al. [14]. Reversibility and methacholine responsiveness were measured on two separate days. Airway responsiveness was only measured if FEV1 before methacholine was 80% or more of the individual’s baseline value. 2.5. Statistical analysis In the results, the mean with standard deviation is given for continuous variables; for categorical variables the number of cases is given. For the comparison of the two treatment arms with respect to exacerbations, disabilities, absence from school and parental absence from work because of asthma, FEV1 and PD methacholine, the t-test or Fisher’s exact test was used. Finally, repeated measurement analyses were used to examine the change in time of FEV1. A significance level of 5% was used. A power analysis beforehand required 60 patients totally, 30 in each group.
3. Results Twenty-nine children (19 boys, 10 girls), 4–11 years of age, with moderate asthma were recruited from two outpatient paediatric clinics. For baseline characteristics, see Tables 1 and 3. After 8 months, 1 patient in the control group was withdrawn because of psychological reasons. His data are included in the analysis until withdrawal. For results see Table 2.
Table 1 Baseline patient characteristics (N = 29) Experimental group
Control group
N Mean (age range) Boys/girls
14 6 (4–10) 10/4
15 7 (4–11) 9/6
0.5 0.7
Allergy, number positive House dust mite Cat Dog Grass pollen FEV1 before salbutamola FEV1 after 0.4 mg salbutamola FEV1 before methacholinea PD20 methacholine mgb
11 5 6 5 100 (13) 109 (12) 97 (17) 32 (8,55)
10 8 6 3 105 (17) 115 (17) 104 (13) 23 (3,61)
0.7 0.5 1.0 0.4 0.4 0.3 0.6 0.3
a b
p-value
FEV1 mean percentage predicted (S.D.). PD20 methacholine median (quartiles).
3.1. Primary outcome measures Mild exacerbations occurred 85 times in the experimental group and 87 times in the control group. The number of exacerbations varied between 0 (1 patient in the experimental group, 3 in the control group) and 21 (1 patient in the control group). For distribution of exacerbations, see Table 2. In the experimental group, no prodromal signs had been recognised in 48% of the exacerbations. There is no statistically significant difference between the two groups (p = 1.0). Two severe exacerbations were found in the experimental group and 6 in the control group. One child in the control group had to be admitted to hospital for an asthma exacerbation. In the experimental group, prodromal signs were registered in 112 occasions. In 25% of the cases, the dose of ICS was doubled adequately; the dose of ICS was adapted inadequately in 50% of the cases (inadequate number of days and/or dose) and remained unchanged in 25%. There were no differences in disabilities, absence from school and parental absence from work between the groups. 3.2. Secondary outcome measures FEV1 (pre- and post-bronchodilator) and PD20 FEV1 methacholine did not show a statistically significant difference between the two groups at the end of the study. In the experimental group, mean FEV1 percentage predicted Table 2 Distribution of frequency of mild exacerbations Number of exacerbations
Experimental group
Control group
N 0–2 3–5 6–10 >10
14 4 3 5 2
15 5 3 5 2
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(S.D.) increased from 100 (13) to 110 (10), in the control group from 105 (17) to 110 (16). PD20 methacholine median (quartiles) increased likewise in both groups: from 32 (8, 55) to 63 (42, 127) in the experimental group, and from 23 (3, 61) to 57 (48, 139) in the control group.
4. Discussion and conclusion With regard to the first study question—the possibility of teaching patients to recognise prodromal signs—the results showed that recognition of prodromal signs was poor. The second study question regarded compliance to self-treatment instructions of doubling inhalation medication during one week. Only in 25% of the cases, the dose of ICS was doubled as advised; 50% did this erratically (inadequate number of days and/or dose) and 25% not at all. The third research question regarded the effect of instructions to double inhaled corticosteroids during one week at first prodromal signs on primary and secondary outcome measures and showed no significant decrease of number or severity of asthma attacks. We conclude that the use of prodromal signs as a signal for change in asthma medication, is not feasible for all children with asthma. In the following, we will discuss these results in connection to the corresponding literature and to clinical implications. 4.1. Discussion First, recognising prodromal signs requires correct symptom perception. Recent studies [15,16] suggest that symptom perception is a highly individual and subjective experience, where psychological factors may play a bigger role than ‘objective’ airway obstruction. This implies that due to individual differences in experiencing prodromal signs the instructions of physicians to adapt medication according to first symptoms will not always be executed. Secondly, non-acceptance of the illness may have stopped patients from reacting to early symptoms. Recently Bonner et al. [17] emphasised that families’ readiness to react in time to symptoms and to manage asthma actively, is a developmental process of acceptance of the illness. They name four stages of acceptance of asthma, as a prerequisite to adequate perception of symptoms and concomitant self regulation. The four stages go from avoidance to accept asthma and its symptoms (stage 1), to asthma acceptance (stage 2), to compliance of asthma medication (stage 3) and finally to asthma self-regulation (stage 4). Possibly both incorrect symptom perception and insufficient acceptance of the asthma in this study have been crucial in not executing self-treatment instructions. The issue of poor compliance to inhalation medication in children with asthma may have played a role in our negative results of study question 2. Several studies on compliance [4,18–22] focussed on poor adherence to daily inhalation medication. No study was done in children regarding
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adherence to instructions of adding as needed medication. In adults, with asthma, a randomised study on the effects of a self-treatment instructional program indicated that improvements in the clinical outcome of asthma were poor, although patients in the self-treatment group did show better scores in subjective outcome measures such as perceived control of asthma and self-confidence than patients in the control group [23]. Recently Thoonen [24] found positive results of a self treatment plan in adult patients with less severe asthma. Only the study of Volovitz et al. [9] concerned children (aged 1–14 years). They found similar results to our study, emphasising the need of compliance to the self-treatment plan in order to find any positive result of the increased medication. Another aspect influencing compliance and results may be the developmental level of children. A certain abstraction level is needed in order to really understand how taking (extra) inhalation medication before an exacerbation has occurred can effect airway organs. Children aged 4–8 years cannot have a good understanding of this connection, but even in parents this is not always adequate [25]. Our focus was on parents when children were under 8 years and on children when above 8 years. Perhaps our instructions to patients in the experimental group was not sufficiently adapted to the level of development and understanding of both children and their parents. These developmental aspects earn more attention in instructions to chronic ill patients. Finally, certain illness beliefs [5], such as the hope of parents that symptoms would disappear spontaneously without having to add medication or the fear of side effects of medication, may have played a role in waiting to give extra medication. Mostly young parents participated in our study who were not yet familiar with the process of how asthma exacerbations begin and its preceding prodromal signs. A recent review [27] on the complexity of medication compliance summarises the above by underlining the importance of a multi-component approach to enhance adherence to medication regimens. They believe a one method program to increase compliance will not be sufficient and they favour an approach containing seven variables which are all important determinants of compliance. These variables include, besides enhancing knowledge of asthma and medication efficacy, consideration of illness beliefs and of the personal symptom perception strategies, anxiety level and self-efficacy, as well as patientphysician congruence. The third study question concerned the effect of doubling the dose of ICS at the start of prodromal signs on frequency and severity of asthma attacks, a method which was advocated for several years in the asthma guidelines but not yet studied sufficiently in children with asthma [6–8,26]. The lack of significant differences makes it disputable whether it is useful to incorporate an advice to double the dose of ICS at prodromal signs in asthma guidelines. Recent studies [9,28] concluded that doubling the dose of inhaled corticosteroid at the start of an asthma exacerbation turned
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Table 3 Asthma-related morbidity during the study year
Hospital admissions because of asthma Number of severe exacerbations Number of mild exacerbations Number of days with symptomsa Number of nights with symptomsa Number of days with disabilitiesa Number of days of absence from schoola Number of days parents were absent from worka a
Experimental group (n = 14)
Control group
p-value (n = 15)
0 2 85 55 (39) 37 (33) 21 (23) 6 (11) 3 (8)
1 6 87 54 (51) 43 (42) 15 (26) 5 (6) 1 (1)
1.0 0.2 0.9 0.6 0.8 0.4 0.9 0.7
Mean (S.D.).
out to be not as effective as expected. Most studies (all on small groups) of doubling ICS have been published during or after the start of our project and so results were not yet known to us when we started this study. Due to our and other studies, the common guideline advice of doubling ICS is not being given anymore now but a more individualised stepwise approach of increasing as needed medication is advocated. We encountered several methodological difficulties during our study. First, the number of patients, the assumption that more attacks would occur in ‘steroid naive’ than in those who are on inhaled steroids already for several years made us decide to exclude those children who were already on daily inhaled steroids (ICS). Based on investigation of medical records in the two previous years, a number of about 75 steroid naive children was expected to be included within one year which would be sufficient according to power analysis. However, it turned out to be extremely difficult to find enough ‘steroid-naive’ patients. This recruitment problem may be explained by a recent change in prescription habits of Dutch general practitioners who used to be reluctant to prescribe ICS until a few years ago. Furthermore, apparently not all asthma exacerbations are preceded by prodromal signals [26,28]. In our study, almost half of the exacerbations in the experimental group was not preceded by prodromes which was unexpected. Finally, there may have been too small a difference between the program for the experimental group in comparison to the control group, as both received extended instructions on asthma and medication. In conclusion, the use of prodromal signs to start off self-treatment activities in order to prevent asthma exacerbations is not feasible for all children with asthma. Poor symptom perception, poor compliance and no full acceptance of the illness all influence the use of a stepwise self-treatment program. 4.2. Practical implications Practical implications of this study relate to selftreatment instructions as a part of a self-management plan. Self-treatment in chronic ill children requires individualised and repeated instructions by health care providers. Focus should be on several prerequisites which are conditional to
an effective self-treatment plan: first, giving attention to acceptance of the illness and developmental level of child and parents, secondly, using a multi-facetted program to enhance compliance to self-treatment regimens. Individually tailored instructions by health care providers imply taking time to teach parents and children how prodromal signs present themselves. In young parents, one should realise that it may take several months for parents to know which prodromal signs are specific for their child, thus causing a delay in their increasing medication despite instructions. Compliance to the self-treatment plan should be enhanced by talking with patients about their beliefs of the illness and the (possible side-) effects of increasing medication when no exacerbation has occurred yet, about their perception of symptoms and their feeling of selfefficacy to act in time [27,29]. Periodical follow-up visits, ideally to the same doctor (and specialised nurse), may help parents and children in this difficult process of recognising early symptoms, of acting in time and according to selftreatment instructions. These issues seem to be important in self-treatment plans for all those patients with chronic illnesses who need to adapt their medication according to their symptoms.
References [1] Rietveld S, Colland VT. The impact of severe asthma on schoolchildren. J Asthma 1999;36:409–17. [2] Colland VT, Schlo¨ sser M. Self-management bij kinderen met astma (Self-management in children with asthma). In: van Schayck CP, Wesseling GJ, editors. Behandelings strategiee¨ n bij astma. Cure and Care 1999. Houten/Diegem: Bohn Stafleu Van Loghum; 1999. p. 83– 93. [3] Bender B, Milgrom H, Rand C, Ackerson L. Psychological factors associated with medication non adherence in asthmatic children. J Asthma 1998;35:347–53. [4] Es van SM, Kaptein AA, Bezemer PD, Nagelkerke AF, Colland VT, Bouter LM. Predicting adherence to prophylactic medication in adolescents with asthma: an application of the ASE-model. Pat Educ Couns 2002;47:165–71. [5] Scharloo M. Illness perceptions, coping and functional status in chronic patients. In: Dissertation.. Leiden: University press; 2002. [6] Warner JO, Neijens HJ, Landau LI. Asthma: a follow-up statement from an international paediatric asthma consensus group. Arch Dis Child 1992;67:240–8.
V.T. Colland et al. / Patient Education and Counseling 55 (2004) 416–421 [7] Caplin C, Macarthur C, Stephens D, Feldman W, Parkin PC. Effectiveness of prophylactic steroids in childhood asthma: a systematic review of the literature. J All Clin Immunol 1997;100: 452–7. [8] Agertoft L, Pedersen S. Effects of long-term treatment with ICS on growth and pulmonary function in asthmatic children. Respir Med 1994;88:373–81. [9] Volovitz B, Nussinovitch M, Finkelstein Y, Harel L, Varsano I. Effectiveness of inhaled corticosteroids in controlling acute asthma exacerbations in children at home. Clin Pediatr 2001;40:79–86. [10] Brunette MG, Lands L, Thibodeau LP. Childhood asthma: prevention of attacks with short-term corticosteroid treatment of upper respiratory tract infection. Pediatrics 1988;81:624–9. [11] Beer S, Laver J, Karpuch J, Chabut S, Aladjem M. Prodromal features of asthma. Arch Dis Child 1987;62:345–8. [12] American Thoracic Society, 1987. Standards for the diagnosis and care of patients with chronic obstructive pulmonary diseases (COPD) and asthma. Am Rev Respir Dis 1987;136:225–44. [13] Zapletal A, Samanek M, Tuma S, Ruth C, Paul T. Assessment of airway function in children. Bull Physiopathol Respir 1972;8:535–43. [14] Duiverman EJ, Neijens HJ, Van Strik R, Affourtit MJ, Kerrebijn KF. Lung function and bronchial responsiveness in children who had infantile bronchiolitits. Pediatr Pulmon 1987;3:38–44. [15] Rietveld S, Prins PJM, Colland VT. Accuracy of symptom perception in asthma and illness severity. Child Health Care 2001;30:27–41. [16] Yoos HL, Kitzman H, McMullen A, Henderson C, Sidora K. Symptom monitoring in childhood asthma: a randomized clinical trial comparing peak expiratory flow rate with symptom monitoring. Ann Allergy Asthma Immunol 2002;88:283–91. [17] Bonner S, Zimmerman BJ, Evans D, Irigoyen M, Resnick D, Mellins RB. An individualised intervention to improve asthma management among urban latino and African–American families. J Asthma 2002;39(2):167–79. [18] Rand CS. Adherence to asthma therapy in the preschool child. Allergy, 2002; suppl. 74:48–57
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[19] Colland VT, Nagelkerke AF. Waarom zou ik? Therapie(on)trouw bij kinderen met astma [Why should I? (Non-)adherence in children with asthma] T V Kindergen 1998;66:153–7. [20] Jonasson G, Carlsen KH, Sodal A, Jonasson C, Mowinkel P. Patient compliance in a clinical trial with inhaled budesonide in children with mild asthma. Eur Respir J 1999;14:150–4. [21] Es SM. van, Nagelkerke AF, Colland VT, Scholten RJPM, Bouter LM. An intervention programme using the ASE-model aimed at enhancing adherence in adolescents with asthma. Pat Educ Couns 2001;44:193– 203. [22] Cochrane GM, Horne R, Chanez P. Compliance in asthma. Respir Med 1999;93:763–9. [23] Palen J d, Klein JJ, Zielhuis GA, van Herwaarden CL, Seydel ER. Behavioural effect of self-treatment guidelines in a self-management program for adults with asthma. Pat Educ Couns 2001;43:161–9. [24] Thoonen BP, Schermer TR, Akkermans RP, den Otter JJ, Grol R, van Schayck OC. Willingness of patients to perform self-management of asthma and the role of inhaled steroids. Scan J Prim Health Care 2002;20:60–4. [25] Donnelly JE, Donnelly WJ, Thong YH. Inadequate parental understanding of asthma medications. Ann Allergy 1989;62:337–41. [26] Essen-Zandvliet EEMM a, Hughes MD, Waalkens HJ, Duiverman EJ, Pocock SJ, Kerrebijn KF. Effects of 22 months treatment with ICS and/ or beta-2-agonist on lung function, airway responsiveness and symptoms in children with asthma. Am Rev Respir Dis 1992;146:547–54. [27] Rietveld S, Koomen JS. A complex system perspective on medication compliance information for health care providers. Dis Man Health Outc 2002;10:1–10. [28] Garrett J, Williams S, Wong C, Holdaway D. Treatment of acute asthma exacerbations with an increased dose of inhaled steroid. Arch Dis Child 1998;79:12–7. [29] Schreurs K, Colland V, Kuijer R, Ridder D de, Elderen Th. Van. Selfmanagement in patients with chronic diseases requiring self-care behaviours: Feasibility of a minimal intervention program. Patient Educ Couns 2003;51:133–141.
Poor adherence to self-medication instructions in children with asthma and their parents$ Vivian T. Collanda,d,*, Liesbeth E.M. van Essen-Zandvlieta,b, Caroline Lansa, Anne Denteneera, Paul Westersc, Hein J.L. Brackelb a
Asthma Centre Heideheuvel Soestdijkerstraatweg 1291213 VX Hilversum The Netherlands Department of Paediatric Pulmonology, University Medical Centre Utrecht/Wilhelmina Children’s Hospital, Utrecht, The Netherlands c Centre for Biostatistics, Utrecht University, The Netherlands d Department of Health Psychology, Utrecht University, The Netherlands
b
Received 7 May 2002; received in revised form 20 March 2003; accepted 13 April 2003
Abstract This study describes a self-treatment program for parents of children with asthma. The aim was to prevent asthma exacerbations by learning to recognise prodromal signs and acting upon them by increasing inhaled corticosteroids (ICS). The study questions were: (1) can we teach parents and children to recognise prodromal signs? (2) are instructions to increase inhalation medication followed? (3) will frequency and severity of asthma attacks diminish subsequently? Due to physicians’ changed attitude towards prescription of ICS, fewer children could be recruited who were ‘‘ICS-naı¨ve’’ than expected. Twenty-nine children of the age of 4–11 years with moderate asthma, participated in a one year prospective randomised study. Structured information was given to all patients on asthma, symptoms and medication. The experimental group received additional information on recognising prodromal signs and doubling ICS during one week. Only in 25% of the patients who recognised prodromal signs the dose of ICS was doubled (as prescribed), in 75% inadequately or not at all. Recognition of prodromal signs was poor as well as compliance to increase as-needed medication. No significant decrease of asthma symptoms occurred in the experimental group. Clinical implications are important for self-treatment instructions: an individually tailored and multi-component program should be offered by health care providers in order to help the patient to recognise early alarm symptoms, comply to self-treatment instructions and to make adaptations for continuous self-regulation. # 2004 Elsevier Ireland Ltd. All rights reserved. Keywords: Asthma; Child; Self-regulation; Compliance; Asthma-management
1. Introduction Asthma in childhood is characterised by short periods of wheezing, tightness of airways, feeling of dispnoe and tiredness, caused by a chronic airway inflammation. Allergens, weather changes, smoke, exercise and stress may all cause symptoms in the child with asthma. Often asthma symptoms cause problems to children and their $ This study was partly sponsored by a grant from the Netherlands Asthma Foundation (grant 94.31). * Corresponding author. Tel.: +31 356 881411; fax: +31 356 881499. E-mail address: [email protected] (V.T. Colland).
parents in daily life as it influences sleep at night, social and emotional development, functioning at school, and physical daily activities [1,2]. Beliefs and behaviours of patients with asthma have been shown to influence their adherence to preventive medication regimes and to asthma management [3–5]. For children with moderate to severe asthma, treatment consists of daily maintenance medication with inhaled corticosteroids (ICS) [6,7]. Intervention at early symptoms seems to be beneficial for long term prognosis [8,9] although randomised prospective studies in children are lacking. Many physicians advise to double the dose of ICS in a period of more symptoms, as part of an asthma selftreatment plan [6]. Parents are told to double the dose of ICS
0738-3991/$ – see front matter # 2004 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.pec.2003.04.010
V.T. Colland et al. / Patient Education and Counseling 55 (2004) 416–421
when they recognise the very first symptoms of an impending asthma period (so called ‘prodromal signs’), in order to prevent an asthma attack or worsening of symptoms [7–11]. Very few prospective studies on the effect of doubling ICS in steroid-naive children had been done at the start of this project. Only one study [9] investigated the effect of increasing inhaled corticosteroids at the first signs of exacerbations in children with asthma aged 1–14 years. This study [9] found that the most important determinant of the effect of the self-treatment plan was the amount of compliance to the self-medication regime. More studies are needed to investigate the effect of doubling the dose of ICS in children with asthma. This was one of the aims of our study. New in this study is our adding of a structured interview to help patients recognise prodromal signs and to teach how to act upon them. In this study, we investigated three questions related to a self-treatment plan: (a) is it feasible to teach patients to recognise prodromal signs?, (b) will patients comply with instructions to act upon first symptoms by doubling the amount of ICS during one week?, and (c) what is the effect of doubling ICS on the frequency and severity of asthma exacerbations?
2. Materials and methods 2.1. Patients Children with moderate asthma according to the American Thoracic Society criteria [12] were eligible for the study when they met the following inclusion criteria: age above 4, ability to perform reproducible lung function tests, (inhaled) corticosteroid-naive and an indication for starting maintenance treatment with ICS, (for parents and child) ability to speak and understand Dutch adequately. Twentynine children (19 boys, 10 girls), 4–11 years of age, were recruited from the outpatient paediatric clinics of Asthma Centre ‘Heideheuvel’ in Hilversum, and the University Medical Centre Utrecht, Department ‘Wilhelmina Children’s Hospital’, both in the Netherlands. The study was approved by the medical ethical committees of both hospitals and all parents gave their written informed consent. 2.2. Study design and method The study was a single blind prospective randomised study during one year. In the two-week run-in period only inhaled beta-2-agonists on demand were allowed. Randomisation was performed by an independent secretary in one of the hospitals, with stratification by centre and age. All patients were prescribed daily maintenance medication with a dose of 400 mg beclomethasone dipropionate or budesonide or 200–250 mg fluticasone propionate, divided over two doses. Most children received the medication by a spacer, some as dry powder formula.
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2.3. The program In both groups, children and parents received individual structured information from the paediatrician about asthma, symptoms, preventive measures, medication and asthma exacerbations during 2 one-hour sessions. The children and parents in the experimental group received additional information about individual prodromal signs, which were (if possible) identified together with the parents (for example, changes in child’s looks, behaviour, emotions, abdominal pain, cough, wheezing, fatigue, running nose or restless sleep). Patients in the experimental group were advised to double the daily dose of ICS for one week when these signs occurred. Patients were seen every 2 months at the out-patient clinic during one year including height and weight measurement. Throughout the study period all patients kept diary cards on which they registered peak flow (PF), medication and symptoms (the experimental group registered prodromal signs as well). Morning and evening PF were performed on a Personal Best Peak Flow Meter (Respironics, NJ, USA) and registered. PF measurements were used as day-to-day monitor for asthma exacerbations, including need of additional bronchodilatory therapy. Absence or presence of asthma symptoms, disabilities by asthma, absence from school and absence from work by the parent because of asthma of the child were registered daily on diary cards throughout the whole study. At each visit the doctor and parent (and child, when old enough) discussed the diary card, and how symptom perception and/or decrease of PF had been used to take additional medication. In the experimental group, maximal attention was focussed on recognition of prodromal signs and adjusting the dose of ICS immediately when parents recognised these signs. When they had not increased the dose of ICS, the reason why was discussed, and they were reinforced again to increase the dose at the very first prodromal sign. Inhalation technique and PF technique were checked at every visit. Primary outcome measures were the rate and severity of asthma attacks, frequency of disabilities, absence from school and parental absence from work due of asthma, registration of prodromal signs and compliance to selftreatment instructions (only in the experimental group). Secondary outcome measures were lung function expressed as forced expiratory volume in 1 s (FEV1) and bronchial responsiveness expressed as provocative dose of methacholine which causes a fall of 20% in FEV1 (PD20 FEV1 methacholine). 2.4. Lung function measurements At the start and the end of the study, lung function including reversibility and bronchial responsiveness to methacholine was measured. Before entry into the study, allergy was tested by RAST on house dust mite, cat, dog and grass pollen. A mild asthma exacerbation was defined as a
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period of at least 2 days with asthma symptoms for which broncho- dilatory medication was used. When in the middle of a period with bronchodilatory use one day no bronchodilator was used, the period was counted as one exacerbation; when on two or more days no bronchodilator was used, exacerbations were counted separately. An exacerbation was defined as severe if a course of prednisolone was prescribed. Patients were withdrawn from the study if it was not ethical to continue the study treatment according to the investigator, or if patients or parents wanted to stop. The time of measurement was between 8.30 and 16.00 h and for each patient constant throughout the study. Tests were only performed when no inhaled bronchodilator had been used during at least 8 h. No lung function measurements were done within the 4-week period after a course of prednisolone. FEV1 was derived from maximal forced expiratory flow-volume curves (Masterlab Body; Jaeger) and expressed as percentage predicted using reference values from Zapletal et al. [13]. Postbronchodilator FEV1 was measured 20 min after inhalation of 0.4 mg salbutamol administered by a volumatic spacer (Glaxo Wellcome, Greenford, UK) as 2 puffs of 0.2 mg. Reversibility tests were performed at the start of the study and at the 10-month visit. Bronchial responsiveness to methacholine was measured at the start and end of the study, using the dosimeter method described by Duiverman et al. [14]. Reversibility and methacholine responsiveness were measured on two separate days. Airway responsiveness was only measured if FEV1 before methacholine was 80% or more of the individual’s baseline value. 2.5. Statistical analysis In the results, the mean with standard deviation is given for continuous variables; for categorical variables the number of cases is given. For the comparison of the two treatment arms with respect to exacerbations, disabilities, absence from school and parental absence from work because of asthma, FEV1 and PD methacholine, the t-test or Fisher’s exact test was used. Finally, repeated measurement analyses were used to examine the change in time of FEV1. A significance level of 5% was used. A power analysis beforehand required 60 patients totally, 30 in each group.
3. Results Twenty-nine children (19 boys, 10 girls), 4–11 years of age, with moderate asthma were recruited from two outpatient paediatric clinics. For baseline characteristics, see Tables 1 and 3. After 8 months, 1 patient in the control group was withdrawn because of psychological reasons. His data are included in the analysis until withdrawal. For results see Table 2.
Table 1 Baseline patient characteristics (N = 29) Experimental group
Control group
N Mean (age range) Boys/girls
14 6 (4–10) 10/4
15 7 (4–11) 9/6
0.5 0.7
Allergy, number positive House dust mite Cat Dog Grass pollen FEV1 before salbutamola FEV1 after 0.4 mg salbutamola FEV1 before methacholinea PD20 methacholine mgb
11 5 6 5 100 (13) 109 (12) 97 (17) 32 (8,55)
10 8 6 3 105 (17) 115 (17) 104 (13) 23 (3,61)
0.7 0.5 1.0 0.4 0.4 0.3 0.6 0.3
a b
p-value
FEV1 mean percentage predicted (S.D.). PD20 methacholine median (quartiles).
3.1. Primary outcome measures Mild exacerbations occurred 85 times in the experimental group and 87 times in the control group. The number of exacerbations varied between 0 (1 patient in the experimental group, 3 in the control group) and 21 (1 patient in the control group). For distribution of exacerbations, see Table 2. In the experimental group, no prodromal signs had been recognised in 48% of the exacerbations. There is no statistically significant difference between the two groups (p = 1.0). Two severe exacerbations were found in the experimental group and 6 in the control group. One child in the control group had to be admitted to hospital for an asthma exacerbation. In the experimental group, prodromal signs were registered in 112 occasions. In 25% of the cases, the dose of ICS was doubled adequately; the dose of ICS was adapted inadequately in 50% of the cases (inadequate number of days and/or dose) and remained unchanged in 25%. There were no differences in disabilities, absence from school and parental absence from work between the groups. 3.2. Secondary outcome measures FEV1 (pre- and post-bronchodilator) and PD20 FEV1 methacholine did not show a statistically significant difference between the two groups at the end of the study. In the experimental group, mean FEV1 percentage predicted Table 2 Distribution of frequency of mild exacerbations Number of exacerbations
Experimental group
Control group
N 0–2 3–5 6–10 >10
14 4 3 5 2
15 5 3 5 2
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(S.D.) increased from 100 (13) to 110 (10), in the control group from 105 (17) to 110 (16). PD20 methacholine median (quartiles) increased likewise in both groups: from 32 (8, 55) to 63 (42, 127) in the experimental group, and from 23 (3, 61) to 57 (48, 139) in the control group.
4. Discussion and conclusion With regard to the first study question—the possibility of teaching patients to recognise prodromal signs—the results showed that recognition of prodromal signs was poor. The second study question regarded compliance to self-treatment instructions of doubling inhalation medication during one week. Only in 25% of the cases, the dose of ICS was doubled as advised; 50% did this erratically (inadequate number of days and/or dose) and 25% not at all. The third research question regarded the effect of instructions to double inhaled corticosteroids during one week at first prodromal signs on primary and secondary outcome measures and showed no significant decrease of number or severity of asthma attacks. We conclude that the use of prodromal signs as a signal for change in asthma medication, is not feasible for all children with asthma. In the following, we will discuss these results in connection to the corresponding literature and to clinical implications. 4.1. Discussion First, recognising prodromal signs requires correct symptom perception. Recent studies [15,16] suggest that symptom perception is a highly individual and subjective experience, where psychological factors may play a bigger role than ‘objective’ airway obstruction. This implies that due to individual differences in experiencing prodromal signs the instructions of physicians to adapt medication according to first symptoms will not always be executed. Secondly, non-acceptance of the illness may have stopped patients from reacting to early symptoms. Recently Bonner et al. [17] emphasised that families’ readiness to react in time to symptoms and to manage asthma actively, is a developmental process of acceptance of the illness. They name four stages of acceptance of asthma, as a prerequisite to adequate perception of symptoms and concomitant self regulation. The four stages go from avoidance to accept asthma and its symptoms (stage 1), to asthma acceptance (stage 2), to compliance of asthma medication (stage 3) and finally to asthma self-regulation (stage 4). Possibly both incorrect symptom perception and insufficient acceptance of the asthma in this study have been crucial in not executing self-treatment instructions. The issue of poor compliance to inhalation medication in children with asthma may have played a role in our negative results of study question 2. Several studies on compliance [4,18–22] focussed on poor adherence to daily inhalation medication. No study was done in children regarding
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adherence to instructions of adding as needed medication. In adults, with asthma, a randomised study on the effects of a self-treatment instructional program indicated that improvements in the clinical outcome of asthma were poor, although patients in the self-treatment group did show better scores in subjective outcome measures such as perceived control of asthma and self-confidence than patients in the control group [23]. Recently Thoonen [24] found positive results of a self treatment plan in adult patients with less severe asthma. Only the study of Volovitz et al. [9] concerned children (aged 1–14 years). They found similar results to our study, emphasising the need of compliance to the self-treatment plan in order to find any positive result of the increased medication. Another aspect influencing compliance and results may be the developmental level of children. A certain abstraction level is needed in order to really understand how taking (extra) inhalation medication before an exacerbation has occurred can effect airway organs. Children aged 4–8 years cannot have a good understanding of this connection, but even in parents this is not always adequate [25]. Our focus was on parents when children were under 8 years and on children when above 8 years. Perhaps our instructions to patients in the experimental group was not sufficiently adapted to the level of development and understanding of both children and their parents. These developmental aspects earn more attention in instructions to chronic ill patients. Finally, certain illness beliefs [5], such as the hope of parents that symptoms would disappear spontaneously without having to add medication or the fear of side effects of medication, may have played a role in waiting to give extra medication. Mostly young parents participated in our study who were not yet familiar with the process of how asthma exacerbations begin and its preceding prodromal signs. A recent review [27] on the complexity of medication compliance summarises the above by underlining the importance of a multi-component approach to enhance adherence to medication regimens. They believe a one method program to increase compliance will not be sufficient and they favour an approach containing seven variables which are all important determinants of compliance. These variables include, besides enhancing knowledge of asthma and medication efficacy, consideration of illness beliefs and of the personal symptom perception strategies, anxiety level and self-efficacy, as well as patientphysician congruence. The third study question concerned the effect of doubling the dose of ICS at the start of prodromal signs on frequency and severity of asthma attacks, a method which was advocated for several years in the asthma guidelines but not yet studied sufficiently in children with asthma [6–8,26]. The lack of significant differences makes it disputable whether it is useful to incorporate an advice to double the dose of ICS at prodromal signs in asthma guidelines. Recent studies [9,28] concluded that doubling the dose of inhaled corticosteroid at the start of an asthma exacerbation turned
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Table 3 Asthma-related morbidity during the study year
Hospital admissions because of asthma Number of severe exacerbations Number of mild exacerbations Number of days with symptomsa Number of nights with symptomsa Number of days with disabilitiesa Number of days of absence from schoola Number of days parents were absent from worka a
Experimental group (n = 14)
Control group
p-value (n = 15)
0 2 85 55 (39) 37 (33) 21 (23) 6 (11) 3 (8)
1 6 87 54 (51) 43 (42) 15 (26) 5 (6) 1 (1)
1.0 0.2 0.9 0.6 0.8 0.4 0.9 0.7
Mean (S.D.).
out to be not as effective as expected. Most studies (all on small groups) of doubling ICS have been published during or after the start of our project and so results were not yet known to us when we started this study. Due to our and other studies, the common guideline advice of doubling ICS is not being given anymore now but a more individualised stepwise approach of increasing as needed medication is advocated. We encountered several methodological difficulties during our study. First, the number of patients, the assumption that more attacks would occur in ‘steroid naive’ than in those who are on inhaled steroids already for several years made us decide to exclude those children who were already on daily inhaled steroids (ICS). Based on investigation of medical records in the two previous years, a number of about 75 steroid naive children was expected to be included within one year which would be sufficient according to power analysis. However, it turned out to be extremely difficult to find enough ‘steroid-naive’ patients. This recruitment problem may be explained by a recent change in prescription habits of Dutch general practitioners who used to be reluctant to prescribe ICS until a few years ago. Furthermore, apparently not all asthma exacerbations are preceded by prodromal signals [26,28]. In our study, almost half of the exacerbations in the experimental group was not preceded by prodromes which was unexpected. Finally, there may have been too small a difference between the program for the experimental group in comparison to the control group, as both received extended instructions on asthma and medication. In conclusion, the use of prodromal signs to start off self-treatment activities in order to prevent asthma exacerbations is not feasible for all children with asthma. Poor symptom perception, poor compliance and no full acceptance of the illness all influence the use of a stepwise self-treatment program. 4.2. Practical implications Practical implications of this study relate to selftreatment instructions as a part of a self-management plan. Self-treatment in chronic ill children requires individualised and repeated instructions by health care providers. Focus should be on several prerequisites which are conditional to
an effective self-treatment plan: first, giving attention to acceptance of the illness and developmental level of child and parents, secondly, using a multi-facetted program to enhance compliance to self-treatment regimens. Individually tailored instructions by health care providers imply taking time to teach parents and children how prodromal signs present themselves. In young parents, one should realise that it may take several months for parents to know which prodromal signs are specific for their child, thus causing a delay in their increasing medication despite instructions. Compliance to the self-treatment plan should be enhanced by talking with patients about their beliefs of the illness and the (possible side-) effects of increasing medication when no exacerbation has occurred yet, about their perception of symptoms and their feeling of selfefficacy to act in time [27,29]. Periodical follow-up visits, ideally to the same doctor (and specialised nurse), may help parents and children in this difficult process of recognising early symptoms, of acting in time and according to selftreatment instructions. These issues seem to be important in self-treatment plans for all those patients with chronic illnesses who need to adapt their medication according to their symptoms.
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