Dataset Information

Feasibility trial of a digital self-management intervention 'My Breathing Matters' to improve asthma-related quality of life for UK primary care patients with asthma.

ABSTRACT:

Objective

To assess the feasibility of a randomised controlled trial (RCT) and acceptability of an asthma self-management digital intervention to improve asthma-specific quality of life in comparison with usual care.

Design and setting

A two-arm feasibility RCT conducted across seven general practices in Wessex, UK.

Participants

Primary care patients with asthma aged 18 years and over, with impaired asthma-specific quality of life and access to the internet.

Interventions

'My Breathing Matters' (MBM) is a digital asthma self-management intervention designed using theory, evidence and person-based approaches to provide tailored support for both pharmacological and non-pharmacological management of asthma symptoms.

Outcomes

The primary outcome was the feasibility of the trial design, including recruitment, adherence and retention at follow-up (3 and 12 months). Secondary outcomes were the feasibility and effect sizes of specific trial measures including asthma-specific quality of life and asthma control.

Results

Primary outcomes: 88 patients were recruited (target 80). At 3-month follow-up, two patients withdrew and six did not complete outcome measures. At 12 months, two withdrew and four did not complete outcome measures. 36/44 patients in the intervention group engaged with MBM (median of 4 logins, range 0-25, IQR 8). Consistent trends were observed to improvements in asthma-related patient-reported outcome measures.

Conclusions

This study demonstrated the feasibility and acceptability of a definitive RCT that is required to determine the clinical and cost-effectiveness of a digital asthma self-management intervention.

Trial registration number

ISRCTN15698435.

SUBMITTER: Ainsworth B

PROVIDER: S-EPMC6858238 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Publications

Feasibility trial of a digital self-management intervention 'My Breathing Matters' to improve asthma-related quality of life for UK primary care patients with asthma.

Ainsworth Ben B Greenwell Kate K Stuart Beth B Raftery James J Mair Frances F Bruton Anne A Yardley Lucy L Thomas Mike M

BMJ open 20191112 11

<h4>Objective</h4>To assess the feasibility of a randomised controlled trial (RCT) and acceptability of an asthma self-management digital intervention to improve asthma-specific quality of life in comparison with usual care.<h4>Design and setting</h4>A two-arm feasibility RCT conducted across seven general practices in Wessex, UK.<h4>Participants</h4>Primary care patients with asthma aged 18 years and over, with impaired asthma-specific quality of life and access to the internet.<h4>Intervention ...[more]

PMID: 31722952

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Project description:BackgroundAsthma control in adolescents is low with half of the young people in a London study identified as having suboptimal control when measured using the Asthma Control Test. Control of asthma symptoms can be improved by addressing barriers to good self-management, such as poor understanding of asthma and adherence to medication. The aim of this study was therefore to develop the My Asthma in School (MAIS) intervention for the improvement of asthma control and self-management in adolescents and to test its initial feasibility. The intervention intended to combine a strong focus on theory with a design specifically aimed to engage adolescents.MethodsThe intervention development was based on previous qualitative and quantitative findings, and on guidelines from the Medical Research Council for the development of complex interventions. The COM-B (Capability, Opportunity, Motivation-Behaviour) model was applied to inform the design of intervention elements. Behavioural targets were identified from existing barriers to good asthma self-management and were then used to guide the development of engaging intervention elements, which were described using the Behavioural Change Technique (BCT) Taxonomy version 1. Adolescents were involved throughout this process. The MAIS intervention was tested in a feasibility phase in London secondary schools with adolescents aged between 11 and 13.ResultsThe complex school-based MAIS intervention comprised a first school visit from a theatre group, who conducted a workshop with all year 7-8 students and addressed peer understanding and attitudes to asthma. The second visit included four self-management workshops for adolescents with asthma, including games, short-films and role play activities. Forty different types of techniques to change behaviour were applied, totalling 163 instances of BCT use across intervention elements, addressing all areas of capability, opportunity and motivation. In this initial feasibility study, 1814 adolescents with and without asthma from nine schools received the theatre intervention visit; 23 adolescents with asthma from one of the schools attended the workshop visit. The intervention was found acceptable and engaging, and 91.4% of participants agreed that the workshops changed how they think or feel about asthma.ConclusionThis study demonstrates development and initial feasibility of a complex theory-based intervention, and how it can combine engaging media and interactive elements, to achieve a multi-directional approach to behavioural change. However more work is needed to assess the feasibility of trial processes, including recruitment and delivery format of the workshops.

Project description:BackgroundAsthma is a chronic disease requiring effective self-management to control it and prevent mortality. The use of theory-informed digital interventions promoting asthma self-management is increasing. However, there is limited knowledge concerning how and to what extent psychological theory has been applied to the development of digital interventions, or how using theory impacts outcomes.ObjectiveThe study aimed to examine the use and application of theory in the development of digital interventions to enhance asthma self-management and to evaluate the effectiveness of theory-based interventions in improving adherence, self-management, and clinical outcomes.MethodsElectronic databases (CENTRAL, MEDLINE, EMBASE, and PsycINFO) were searched systematically using predetermined terms. Additional studies were identified by scanning references within relevant studies. Two researchers screened titles and abstracts against predefined inclusion criteria; a third resolved discrepancies. Full-text review was undertaken for relevant studies. Those meeting inclusion criteria were assessed for risk of bias using the Cochrane Collaboration tool. The review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Study outcomes were classified as medication adherence, self-management, asthma control, clinical markers of health, quality of life, other quality of life outcomes, and health care utilization. Effectiveness was calculated as an average outcome score based on the study's reported significance. The Theory Coding Scheme (TCS) was used to establish the extent to which each intervention had applied theory and which theoretical constructs or behavioral determinants were addressed. Associations between TCS scores and asthma outcomes were described within a narrative synthesis.ResultsFourteen studies evaluating 14 different digital interventions were included in this review. The most commonly cited theories were Social Cognitive Theory, Health Belief Model, and Self-Efficacy Theory. A greater use of theory in the development of interventions was correlated with effective outcomes (r=.657; P=.01): only the 3 studies that met >60% of the different uses of theory assessed by the TCS were effective on all behavioral and clinical outcomes measured. None of the 11 studies that met ≤60% of the TCS criteria were fully effective; however, 3 interventions were partially effective (ie, the intervention had a significant impact on some, but not all, of the outcomes measured). Most studies lacked detail on the theoretical constructs and how they were applied to the development and application of the intervention.ConclusionsThese findings suggest that greater use of theory in the development and application of digital self-management interventions for asthma may increase their effectiveness. The application of theory alone may not be enough to yield a successful intervention, and other factors (eg, the context in which the intervention is used) should be considered. A systematic approach to the use of theory to guide the design, selection, and application of intervention techniques is needed.

Project description:Supported self-management reduces asthma-related morbidity and mortality. This paper is on a feasibility study, and observing the change in clinical and cost outcomes of pictorial action plan use is part of assessing feasibility as it will help us decide on outcome measures for a fully powered RCT. We conducted a pre-post feasibility study among adults with physician-diagnosed asthma on inhaled corticosteroids at a public primary-care clinic in Malaysia. We adapted an existing pictorial asthma action plan. The primary outcome was asthma control, assessed at 1, 3 and 6 months. Secondary outcomes included reliever use, controller medication adherence, asthma exacerbations, emergency visits, hospitalisations, days lost from work/daily activities and action plan use. We estimated potential cost savings on asthma-related care following plan use. About 84% (n = 59/70) completed the 6-months follow-up. The proportion achieving good asthma control increased from 18 (30.4%) at baseline to 38 (64.4%) at 6-month follow-up. The proportion of at least one acute exacerbation (3 months: % difference -19.7; 95% CI -34.7 to -3.1; 6 months: % difference -20.3; 95% CI -5.8 to -3.2), one or more emergency visit (1 month: % difference -28.6; 95% CI -41.2 to -15.5; 3 months: % difference -18.0; 95% CI -32.2 to -3.0; 6 months: % difference -20.3; 95% CI -34.9 to -4.6), and one or more asthma admission (1 month: % difference -14.3; 95% CI -25.2 to -5.3; 6 months: % difference -11.9; 95% CI -23.2 to -1.8) improved over time. Estimated savings for the 59 patients at 6-months follow-up and for each patient over the 6 months were RM 15,866.22 (USD3755.36) and RM268.92 (USD63.65), respectively. Supported self-management with a pictorial asthma action plan was associated with an improvement in asthma control and potential cost savings in Malaysian primary-care patients.Trial registration number: ISRCTN87128530; prospectively registered: September 5, 2019, http://www.isrctn.com/ISRCTN87128530 .

Project description:BackgroundReliance on short-acting β-2 agonists and nonadherence to maintenance medication are associated with poor clinical outcomes in asthma. Digital health solutions could support optimal medication use and therefore disease control in patients with asthma; however, their use in community settings has not been determined.ObjectiveThe primary objective of this study is to investigate community implementation of the Turbu+ program designed to support asthma self-management, including adherence to budesonide and formoterol (Symbicort) Turbuhaler, a combination inhaler for both maintenance therapy or maintenance and reliever therapy. The secondary objective is to provide health care professionals with insights into how patients were using their medication in real life.MethodsPatients with physician-diagnosed asthma were prescribed budesonide and formoterol as maintenance therapy, at a dose of either 1 inhalation twice daily (1-BID) or 2 inhalations twice daily (2-BID), or as maintenance and reliever therapy (1-BID and reliever or 2-BID and reliever in a single inhaler), and they received training on Turbu+ in secondary care centers across Italy. An electronic device attached to the patients' inhaler for ≥90 days (data cutoff) securely uploaded medication use data to a smartphone app and provided reminders, visualized medication use, and motivational nudge messages. Average medication adherence was defined as the proportion of daily maintenance inhalations taken as prescribed (number of recorded maintenance actuations per day or maintenance inhalations prescribed per day) averaged over the monitoring period. The proportion of adherent days was defined as the proportion of days when all prescribed maintenance inhalations were taken on a given day. The Wilcoxon test was used to compare the proportion of adherent days between patients in the maintenance regimen and patients in the maintenance and reliever regimen of a given dose.ResultsIn 661 patients, the mean (SD) number of days monitored was 217.2 (SD 109.0) days. The average medication adherence (maintenance doses taken/doses prescribed) was 70.2% (108,040/153,820) overall and was similar across the groups (1-BID: 6332/9520, 66.5%; 1‑BID and reliever: 43,578/61,360, 71.0%; 2-BID: 10,088/14,960, 67.4%; 2-BID and reliever: 48,042/67,980, 70.7%). The proportion of adherent days (prescribed maintenance doses/doses taken in a given day) was 56.6% (31,812/56,175) overall and was higher with maintenance and reliever therapy (1-BID and reliever vs 1-BID: 18,413/30,680, 60.0% vs 2510/4760, 52.7%; P<.001; 2-BID and reliever vs 2-BID: 8995/16,995, 52.9% vs 1894/3740, 50.6%; P=.02). Rates of discontinuation from the Turbu+ program were significantly lower with maintenance and reliever therapy compared with maintenance therapy alone (P=.01).ConclusionsOverall, the high medication adherence observed during the study might be attributed to the electronic monitoring and feedback mechanism provided by the Turbu+ program.

Dataset Information

Feasibility trial of a digital self-management intervention 'My Breathing Matters' to improve asthma-related quality of life for UK primary care patients with asthma.

Objective

Design and setting

Participants

Interventions

Outcomes

Results

Conclusions

Trial registration number

Publications

Feasibility trial of a digital self-management intervention 'My Breathing Matters' to improve asthma-related quality of life for UK primary care patients with asthma.

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