Integrating Comprehensive Geriatric Assessment for people with COPD and frailty starting pulmonary rehabilitation: the Breathe Plus feasibility trial protocol.

One in five people with COPD also lives with frailty. People living with both COPD and frailty are at increased risk of poorer health and outcomes, and face challenges to completing pulmonary rehabilitation. Integrated approaches that are adapted to the additional context of frailty are required. The aim of the present study is to determine the feasibility of conducting a randomised controlled trial of an integrated Comprehensive Geriatric Assessment for people with COPD and frailty starting pulmonary rehabilitation. This is a multicentre, mixed-methods, assessor-blinded, randomised, parallel group, controlled feasibility trial ("Breathe Plus"; ISRCTN13051922). We aim to recruit 60 people aged ≥50 with both COPD and frailty referred for pulmonary rehabilitation. Participants will be randomised 1:1 to receive usual pulmonary rehabilitation, or pulmonary rehabilitation with an additional Comprehensive Geriatric Assessment. Outcomes (physical, psycho-social and service use) will be measured at baseline, 90 days and 180 days. We will also collect service and trial process data, and conduct qualitative interviews with a sub-group of participants and staff. We will undertake descriptive analysis of quantitative feasibility outcomes (recruitment, retention, missing data, blinding, contamination, fidelity), and framework analysis of qualitative feasibility outcomes (intervention acceptability and theory, outcome acceptability). Recommendations on progression to a full trial will comprise integration of quantitative and qualitative data, with input from relevant stakeholders. This study has been approved by a UK Research Ethics Committee (ref.: 19/LO/1402). This protocol describes the first study testing the feasibility of integrating a Comprehensive Geriatric Assessment alongside pulmonary rehabilitation, and testing this intervention within a mixed-methods randomised controlled trial.
Competing Interests: Conflict of interest: L.J. Brighton has nothing to disclose. Conflict of interest: C.J. Evans has nothing to disclose. Conflict of interest: M. Farquhar has nothing to disclose. Conflict of interest: K. Bristowe has nothing to disclose. Conflict of interest: A. Kata has nothing to disclose. Conflict of interest: J. Higman has nothing to disclose. Conflict of interest: M. Ogden has nothing to disclose. Conflict of interest: C. Nolan reports personal fees from Novartis outside the submitted work. Conflict of interest: D. Yi has nothing to disclose. Conflict of interest: W. Gao has nothing to disclose. Conflict of interest: M. Koulopoulou has nothing to disclose. Conflict of interest: S. Hasan has nothing to disclose. Conflict of interest: C. Steves has nothing to disclose. Conflict of interest: W.D-C. Man reports grants from the National Institute for Health Research and the British Lung Foundation, personal fees from Jazz Pharmaceuticals and Mundipharma, grants from Pfizer, personal fees from Novartis, and nonfinancial support from GSK, outside the submitted work. Conflict of interest: M. Maddocks has nothing to disclose.
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