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Implementing a choice of pulmonary rehabilitation models in chronic obstructive pulmonary disease (HomeBase2 trial): protocol for a cluster randomised controlled trial

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posted on 09.05.2022, 23:13 authored by Anne HollandAnne Holland, AW Jones, A Mahal, Natasha LanninNatasha Lannin, Narelle CoxNarelle Cox, G Hepworth, Paul O'HalloranPaul O'Halloran, CF McDonald
INTRODUCTION: There is compelling evidence that either centre-based or home-based pulmonary rehabilitation improves clinical outcomes in chronic obstructive pulmonary disease (COPD). There are known health service and personal barriers which prevent potentially eligible patients from accessing the benefits of pulmonary rehabilitation. The aim of this hybrid effectiveness-implementation trial is to examine the effects of offering patients a choice of pulmonary rehabilitation locations (home or centre) compared with offering only the traditional centre-based model. METHOD AND ANALYSIS: This is a two-arm cluster randomised, controlled, assessor-blinded trial of 14 centre-based pulmonary rehabilitation services allocated to intervention (offering choice of home-based or centre-based pulmonary rehabilitation) or control (continuing to offer centre-based pulmonary rehabilitation only), stratified by centre-based programme setting (hospital vs non-hospital). 490 participants with COPD will be recruited. Centre-based pulmonary rehabilitation will be delivered according to best practice guidelines including supervised exercise training for 8 weeks. At intervention sites, the home-based pulmonary rehabilitation will be delivered according to an established 8-week model, comprising of one home visit, unsupervised exercise training and telephone calls that build motivation for exercise participation and facilitate self-management. The primary outcome is all-cause, unplanned hospitalisations in the 12 months following rehabilitation. Secondary outcomes include programme completion rates and measurements of 6-minute walk distance, chronic respiratory questionnaire, EQ-5D-5L, dyspnoea-12, physical activity and sedentary time at the end of rehabilitation and 12 months following rehabilitation.Direct healthcare costs, indirect costs and changes in EQ-5D-5L will be used to evaluate cost-effectiveness. A process evaluation will be undertaken to understand how the choice model is implemented and explore sustainability beyond the clinical trial. ETHICS AND DISSEMINATION: Alfred Hospital Ethics Committee has approved this protocol. The trial findings will be published in peer-reviewed journals, submitted for presentation at conferences and disseminated to patients across Australia with support from national lung charities and societies. TRIAL REGISTRATION NUMBER: NCT04217330.

Funding

This work is supported by the Commonwealth of Australia Medical Research Future Fund grant MRF1176491. This funding source had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data or decision to submit results.

History

Publication Date

11/04/2022

Journal

BMJ open

Volume

12

Issue

4

Article Number

ARTN e057311

Pagination

(p. e057311)

Publisher

BMJ Publishing Group

ISSN

2044-6055

Rights Statement

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.