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.
- quality of life
- primary care
- breathing retraining
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Twitter @benainsworth, @FrancesMair
Contributors LY, MT and AB conceived the idea for the study. LY, MT, JR, FM, BS and AB secured funding for the study. BA, LY, AB, BS and MT developed the intervention and designed the trial with input from Asthma UK and FM. BA and KG managed the trial on a day-to-day basis with support from LY and MT. BS and JR planned and carried out the statistical analysis. BA drafted the manuscript with assistance and final approval from all authors. LY is the guardian of the data.
Funding This article presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research (PGfAR) Programme (Grant Reference Number RP-PG-1211-20001). My Breathing Matters was developed using LifeGuide software, which was partly funded by the NIHR Southampton Biomedical Research Centre (BRC). LY is an NIHR Senior Investigator and during the study BA was supported by an NIHR School of Primary Care (SPCR) Fellowship. AB was funded by the National Institute for Health Research (NIHR) Senior Research Fellowship (SRF-2012-05-120).
Disclaimer The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.
Competing interests Neither MT nor any member of his close family has any shares in pharmaceutical companies. In the last 3 years, he has received speaker’s honoraria for speaking at sponsored meetings or satellite symposia at conferences from the following companies marketing respiratory and allergy products: GSK, Novartis. He has received honoraria for attending advisory panels with; Boehringer Inglehiem, GSK, Novartis. He is a recent a member of the BTS SIGN Asthma guideline steering group and the NICE Asthma Diagnosis and Monitoring guideline development group. BA, KG, JR, BS, LY, FM and AB have no competing interests.
Patient consent for publication Not required.
Ethics approval The study was approved by NHS South Central—Berkshire Research Ethics Committee, 16/01/2017, ref: 16/SC/0614.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available on reasonable request.
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