Abstract
Introduction The benefits achieved during pulmonary rehabilitation (PR) are known to be sustained for 6–12 months after the initial programme. Several maintenance trials have been conducted but were heterogeneous in terms of duration, frequency and labour cost. There is no consensus on one best strategy. SPACE FOR COPD (Self-management Programme of Activity, Coping and Education for Chronic Obstructive Pulmonary Disease) is a home-based self-management programme, which has been shown previously to be effective in primary and secondary care settings and is to be tested here as a maintenance programme. The aim is to evaluate the efficacy of the SPACE FOR COPD programme (manual and group sessions), on exercise tolerance and mental well-being, compared with usual care following PR in patients with COPD.
Methods and analysis A prospective, multicentre, single-blinded randomised controlled trial requiring 116 participants with a clinical diagnosis of COPD who have finished PR within 4 weeks will be randomised 1:1 to either a usual care group or a SPACE FOR COPD programme group. The intervention comprises a home-based manual and 4, 2-hour group sessions adopting motivational interviewing techniques over 12 months. The primary outcome is endurance capacity measured by the Endurance Shuttle Walking Test at 12 months. Secondary outcomes are: maximal exercise capacity, health-related quality of life, mood, patient activation, physical activity, lung function and healthcare costs. The measures will be taken at baseline, 6 and 12 months. Patient interviews and staff focus groups will be conducted to explore barriers, facilitators and views about the intervention at the end of the study. A framework analysis will be used for the interpretation of qualitative data.
Ethics and dissemination The trial was granted ethical approval from Health Research Authority and Health and Care Research Wales (HCRW19/EM/0267 on 10 October 2019). Results will be made available to all stakeholders through a dissemination event, conferences and peer-reviewed publications.
Trial registration number ISRCTN30110012.
Methods and analysis A prospective, multicentre, single-blinded randomised controlled trial requiring 116 participants with a clinical diagnosis of COPD who have finished PR within 4 weeks will be randomised 1:1 to either a usual care group or a SPACE FOR COPD programme group. The intervention comprises a home-based manual and 4, 2-hour group sessions adopting motivational interviewing techniques over 12 months. The primary outcome is endurance capacity measured by the Endurance Shuttle Walking Test at 12 months. Secondary outcomes are: maximal exercise capacity, health-related quality of life, mood, patient activation, physical activity, lung function and healthcare costs. The measures will be taken at baseline, 6 and 12 months. Patient interviews and staff focus groups will be conducted to explore barriers, facilitators and views about the intervention at the end of the study. A framework analysis will be used for the interpretation of qualitative data.
Ethics and dissemination The trial was granted ethical approval from Health Research Authority and Health and Care Research Wales (HCRW19/EM/0267 on 10 October 2019). Results will be made available to all stakeholders through a dissemination event, conferences and peer-reviewed publications.
Trial registration number ISRCTN30110012.
| Original language | English |
|---|---|
| Article number | e055513 |
| Number of pages | 10 |
| Journal | BMJ Open |
| Volume | 12 |
| Early online date | 25 Apr 2022 |
| DOIs | |
| Publication status | Published - 25 Apr 2022 |
Bibliographical note
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/.Funder
The trial was granted ethical approval from Health Research Authority and Health and Care Research Wales (HCRW) with Research Ethics Committee number 19/ EM/0267 on 10 October 2019. The first participant was recruited on 18 October 2019. The study is sponsored by University Hospitals of Leicester NHS Trust and funded by National Institute for Health Research with grant number PB-PG-0317-20032. Amendments to protocol will go through HCRW and sponsor before enforcement. Funding Information: Funding This work was funded by the National Institute for Health Research (NIHR) Research for Patient Benefit Programme, grant number (PB-PG-0317-20032) and supported by the NIHR Leicester Biomedical Research Centre (BRC)-Respiratory. Publisher Copyright: © 2022 BMJ Publishing Group. All rights reserved.Keywords
- Chronic airways disease
- Protocols & guidelines
- QUALITATIVE RESEARCH
- REHABILITATION MEDICINE
- RESPIRATORY MEDICINE (see Thoracic Medicine)
ASJC Scopus subject areas
- General Medicine