Benefits of an education programme on the self-management of aerosol and airway clearance treatments for children with cystic fibrosis
Abstract
Adherence to recommended aerosol medicines and airway clearance techniques (ACT) for children with cystic fibrosis (CF) requires self-management skills. A multi-centre, randomized, controlled trial was conducted to investigate the effectiveness of a self-management education programme called 'Airways' for six- to 11-year old children with CF and their caregivers. Assessments were conducted immediately before and after the intervention period, and six and 12 months after the post-intervention assessment. The pen and paper education programme was completed by the child and caregiver together at home. Participants in the intervention and control groups had similar baseline characteristics. A per-protocol analysis was conducted and for variables that changed significantly, an additional intention-to-treat analysis was performed that included data from participants in the intervention group who withdrew from the study during the intervention period. The intervention group increased the percentage of prescribed aerosols taken (P < 0.001) and this was maintained at 12-month follow-up (P < 0.001). There was no change in the percentage of prescribed ACT performed, although when the child was unwell, caregivers in the intervention group increased the frequency and/or duration of ACT (P = 0.028) in the per-protocol analysis but not in the intention-to-treat analysis. Children in the intervention group increased their knowledge of ACT (P < 0.001) which was maintained at 12-month follow-up (P < 0.001) and felt more positively about their chest treatment regimens immediately following the intervention (P = 0.017) but not at 12-month follow-up. There were no significant changes in the control group for these variables over time. No significant changes occurred in the caregivers' reports of self-management behaviours and self-efficacy in either group. The positive results suggest that 'Airways' is a valuable educational tool for primary school-aged children with CF and their caregiver.
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Most included trials had small sample sizes; seven trials had fewer than 100 participants and many stated they were underpowered.
“Most included trials had small sample sizes; seven trials had fewer than 100 participants and many stated they were underpowered (Cottrell 1996;Downs 2006;Gur 2016;Hind 2017;Knudsen 2016;Quinn 2004;Shakkottai 2017).”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Downs 2006
10 trials (69 references) were included in this review.
“This leaves 10 trials (69 references) for inclusion in this review (Cottrell 1996;Downs 2006;Gur 2016;Hind 2017;Knudsen 2016;Quinn 2004;Quittner 2019;Riekert 2013;Shakkottai 2017;Wildman 2022).”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Downs 2006
Nine of these 10 trials could also be included in limited quantitative syntheses (meta-analyses).
“Nine of these 10 trials could also be included in limited quantitative syntheses (meta-analyses) (Cottrell 1996;Downs 2006;Gur 2016;Hind 2017;Knudsen 2016;Quinn 2004;Quittner 2019;Shakkottai 2017;Wildman 2022).”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Downs 2006
Allocation concealment was at high risk of bias in two trials (Downs 2006; Gur 2016) and unclear in five trials (Cottrell 1996; Knudsen 2016; Quittner 2019; Riekert 2013; Shakkottai 2017).
“allocation concealment was at high risk of bias in two trials (Downs 2006;Gur 2016) and unclear in five trials (Cottrell 1996;Knudsen 2016;Quittner 2019;Riekert 2013;Shakkottai 2017).”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Downs 2006
Blinding of outcome assessors was unclear in six trials (Cottrell 1996; Downs 2006; Knudsen 2016; Quinn 2004; Quittner 2019; Riekert 2013) and high risk in four trials (Gur 2016; Hind 2017; Shakkottai 2017; Wildman 2022).
“Blinding of outcome assessors was unclear in six trials (Cottrell 1996;Downs 2006;Knudsen 2016;Quinn 2004;Quittner 2019;Riekert 2013) and high risk in four trials (Gur 2016;Hind 2017;Shakkottai 2017;Wildman 2022).”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Downs 2006
The nine trials provided no description of the 'usual care' comparator, which precluded BCT coding of the control groups.
“The nine trials provided no description of the 'usual care' comparator, which precluded BCT coding of the control groups (Cottrell 1996;Downs 2006;Gur 2016;Hind 2017;Knudsen 2016;Quinn 2004;Quittner 2019;Shakkottai 2017;Wildman 2022).”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Downs 2006
Six trials had low risk of bias in relation to sequence generation.
“We judged six trials to have a low risk of bias in relation to sequence generation (Downs 2006;Hind 2017;Knudsen 2016;Quinn 2004;Quittner 2019;Wildman 2022).”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Downs 2006
One trial stratified randomisation by age and two trials by CF centre and number of IV days in the previous 12 months.
“One trial stratified randomisation by age (Downs 2006) and two trials by CF centre and number of IV days in the previous 12 months (Hind 2017;Wildman 2022).”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Downs 2006
Four trials used randomised permuted blocks, with three specifying computer-generated blocks.
“Four trials used randomised permuted blocks (Downs 2006;Hind 2017;Knudsen 2016;Wildman 2022), with three of these specifying that this was computer-generated (Hind 2017;Knudsen 2016;Wildman 2022).”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Downs 2006
Nine trials (approximately 1514 participants) contributed data to the comparison of psychological interventions versus usual care.
“Nine trials (approximately 1514 participants) contributed data to the comparison of psychological interventions versus usual care (Cottrell 1996;Downs 2006;Gur 2016;Hind 2017;Knudsen 2016;Quinn 2004;Quittner 2019;Shakkottai 2017;Wildman 2022).”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Downs 2006
An intention-to-treat analysis was conducted in the Downs 2006 trial which included data from participants in the intervention group who commenced the intervention and later withdrew (n = 8).
“An intention-to-treat analysis was conducted which included data from participants in the intervention group who commenced the intervention and later withdrew (n = 8).”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Downs 2006
In the Downs 2006 trial, 11 participants (seven in the intervention arm and four in the control arm) did not complete pre-test assessments or withdrew prior to commencing intervention, and so were not included in intention-to-treat analysis.
“However, 11 participants (seven in the intervention arm and four in the control arm) did not complete pre-test assessments or withdrew from the trial prior to commencing intervention, and so were not included in intention-to-treat analysis (Downs 2006).”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Downs 2006
Downs 2006 reported significant attrition from the trial and the potential for bias.
“Downs 2006 reported significant attrition from the trial and the potential for bias.”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Downs 2006
The remaining nine trials compared a psychological intervention to a usual care or 'treatment as usual' control group.
“The remaining nine trials compared a psychological intervention (as described below) to a usual care or 'treatment as usual' control group (Cottrell 1996;Downs 2006;Gur 2016;Hind 2017;Knudsen 2016;Quinn 2004;Quittner 2019;Shakkottai 2017;Wildman 2022).”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Downs 2006
The review authors were unable to access protocols to assess selective reporting for three trials (Cottrell 1996; Downs 2006; Quinn 2004).
“We were unable to access protocols to assess selective reporting for three trials (Cottrell 1996;Downs 2006;Quinn 2004).”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Downs 2006
The review authors identified no other potential sources of bias in six trials (Downs 2006; Hind 2017; Knudsen 2016; Quinn 2004; Shakkottai 2017; Wildman 2022).
“We identified no other potential sources of bias in six trials (Downs 2006;Hind 2017;Knudsen 2016;Quinn 2004;Shakkottai 2017;Wildman 2022).”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Downs 2006
The review authors judged six trials to have an unclear risk of bias for selective reporting (Cottrell 1996; Downs 2006; Gur 2016; Quinn 2004; Riekert 2013; Shakkottai 2017).
“We judged six trials to have an unclear risk of bias for selective reporting (Cottrell 1996;Downs 2006;Gur 2016;Quinn 2004;Riekert 2013;Shakkottai 2017).”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Downs 2006
The minimum number of BCTs used in an intervention was one (Knudsen 2016) and the maximum number was 28 (Downs 2006).
“The minimum number of BCTs used in an intervention was one (Knudsen 2016) and the maximum number was 28 (Downs 2006).”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Downs 2006
Four trials were judged high risk of bias for incomplete outcome data.
“We judged four trials to have a high risk of bias for incomplete outcome data (Cottrell 1996;Downs 2006;Knudsen 2016;Quittner 2019).”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Downs 2006
Two trials showed an increase in adherence between groups, but these were assessed using subjective measures (Downs 2006, Knudsen 2016).
“A further two trials showed an increase in adherence between groups, but these were assessed using subjective measures (e.g.standardised questionnaires or participant diaries) (Downs 2006;Knudsen 2016).”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Downs 2006
Downs 2006 did not provide details of allocation concealment in the published report, but information provided by the lead author on request states that allocation was not concealed.
“the final trial did not provide details of allocation concealment in the published report, but information provided by the lead author on request states that allocation was not concealed (Downs 2006).”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Downs 2006
Downs 2006 used 28 BCTs, the largest number of all included trials.
“This trial used 28 BCTs, the largest number of all included trials (see 'Table 1').”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Downs 2006
In Downs 2006 (n = 51), post-intervention adherence to aerosol treatments was 16.6% greater in the intervention group compared with usual care, but this was not sustained at six months and 12 months.
“Results demonstrated that post-intervention, adherence to aerosol treatments was 16.6% greater in the intervention group compared with usual care, but this was not sustained at six months and 12 months.”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Downs 2006
Two trials (Downs 2006, Gur 2016) had a high risk of bias from allocation concealment.
“We judged the remaining two trials to have a high risk of bias (Downs 2006;Gur 2016).”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Downs 2006
Four trials measured adherence using subjective measures (Cottrell 1996, Downs 2006, Gur 2016, Knudsen 2016).
“Four trials measured adherence using subjective measures (Cottrell 1996;Downs 2006;Gur 2016;Knudsen 2016).”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Downs 2006
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References 34 · Cited by 47
- Authors
- Downs, J. A., Roberts, C. M., Blackmorel, A. M., Le Souëf, P. N., & Jenkins, S. C.
- Affiliations
- Curtin University (AU)
- School of Physiotherapy, Curtin University of Technology, Western Australia
- School of Paediatrics and Child Health, University of Western Australia
- The University of Western Australia (AU)
- ORCID
- Downs, J A
- Venue
- Chronic Respiratory Disease
- Publisher
- SAGE Publications
- Published
- 2006-01
- Volume
- 3
- Issue
- 1
- Pages
- 19-27
- ISSN
- 1479-9723 (ISSN-L)
- 1479-9731
- OpenAlex
- W2133987394
- Cited by
- 47
- References
- 34
- Citations by year
- 2024: 6 · 2023: 4 · 2022: 1 · 2021: 2 · 2020: 2 · 2019: 3 · 2017: 1 · 2016: 5 · 2015: 4 · 2014: 3 · 2013: 2
- FWCI
- 1.77
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Chronic Respiratory Disease (publishedVersion)
- PubMed (publishedVersion)
- UWA Profiles and Research Repository (UWA) (submittedVersion)
- Funders
- Cystic Fibrosis Trust
- Australian Cystic Fibrosis Research Trust
- Physiotherapy Research Foundation
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Cystic Fibrosis Research Advances
- Health Sciences › Health Professions › Pharmacy › Nursing care and research
- Health Sciences › Medicine › Family Practice › Medication Adherence and Compliance
- Keywords
- cystic fibrosis, self-management education, inhalation therapy, airway clearance techniques, children, caregivers, medication adherence, self-efficacy, patient education program, primary school-aged children
- MeSH terms
- Administration, Inhalation, Aerosols, Attitude to Health, Australia, Child, Cystic Fibrosis, Female, Humans, Health Knowledge, Attitudes, Practice, Male, Patient Compliance, Patient Education as Topic, Prospective Studies, Respiratory Therapy, Self Care, Health Behavior, Caregivers, Self Efficacy
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