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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 [with consumer summary]
Ainsworth B, Greenwell K, Stuart B, Raftery J, Mair F, Bruton A, Yardley L, Thomas M
BMJ Open 2019 Nov;9(11):e032465
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

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 to 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.
Reproduced with permission from the BMJ Publishing Group.

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