Type of study
IMPROVE is a cluster randomised controlled clinical trial taking place at PR centres across England. Each PR centre (cluster) that is taking part will be randomly assigned to one of two groups, either ‘intervention’ or ‘control.’
PR centres in the control group will provide their PR service as they usually would.
PR centres in the intervention group will use PR-buddies as well as providing their PR service as usual.
The main thing we will be measuring is how many of the patients referred for PR end up completing it. By comparing the completion rate for the intervention group with the completion rate for the control group, we will be able to see whether PR-buddies help more people to complete PR.
Methods and timeline
Stage 1:
Set-up
Complete
Secure ethical approval and finalise the trial protocol.
Develop a set of teaching materials that intervention sites can use to train a group of PR-buddies. This will be based on the training that was given during our earlier feasibility study.
Recruit pulmonary rehabilitation centres to take part in the trial.
Stage 2:
Internal Pilot
Complete
Conduct an internal pilot with at least 8 initial PR centres.
At the end of the internal pilot, an Independent Trial Steering Committee will decide whether the trial continues. The decision will depend on the success of the pilot.
Stage 3:
Main Trial
Current
Divide 30 PR centres into intervention and control groups to continue the main trial. The principle measured outcome will be the rate of completion of PR at centres in the Intervention group (with PR-buddies) vs the rate of PR completion at centres in the Control group (operating their PR services as normal without PR-buddies).
Stage 4:
Analysis and Reflection
Evaluate the main outcomes and many other aspects of the trial, such as the training given to PR-buddies, PR staff training, and how the intervention was received by patients, the volunteer PR-buddies and the patients that they supported. The economics of the intervention will also be evaluated.
How patients and the public will be involved with the trial
Our advisory group of COPD patient volunteers has been closely involved in developing the PR-buddy intervention and will be involved throughout the trial. You can read about how they helped us with preparing videos for the PR-buddy training in our news feed.
What we hope the IMPROVE trial will achieve
We hope to improve quality of life for people with COPD by increasing the number of referred patients completing PR.
How we will communicate about the trial
The findings will be disseminated through public meetings, charitable and professional associations, a trial website including the latest news from the trial, scientific publications and conference presentations.
