Improving completion of pulmonary rehabilitation with PR-buddies (IMPROVE)
- Conditions
- Chronic obstructive pulmonary diseaseRespiratory
- Registration Number
- ISRCTN12658458
- Lead Sponsor
- King's College London
- Brief Summary
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38500191/ (added 22/03/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1577
Category A - Inclusion criteria of participating pulmonary rehabilitation sites:
1. > 200 pulmonary rehabilitation referrals per year to allow for at least 35 (17.5%) participants to be recruited over six months.
2. Conduct routine baseline and final pulmonary rehabilitation session data including uptake and completion rates, quality of life assessment (COPD Assessment Test-CAT or Chronic Respiratory Questionnaire -CRQ-SAS), exercise tests (Six Minute Walking Distance - 6MWD or Intermittent Shuttle Walk Test - ISWT), and well-being assessment (General Anxiety Disorder Assessment 7 – GAD7) and (Patient Health Questionnaire 9 -PHQ9 or Hospital Anxiety and Depression Scale HADS).
3. Completion rate < = 55% determined by count based on appropriate referrals received. Referrals of non-COPD chest problems and patients with significant other disabilities that prevent participation should not be included in the completion rate denominator. The decision to limit inclusion to sites with a completion rate of 55% or less relates to the priority given to service inequalities and the need for the NHS to have a threshold for the introduction of the intervention. Including all sites may diminish the opportunity to show a difference in those services in greatest need.
4. Agree to randomisation to intervention or usual care
5. Agree to include all eligible patients in the invitation to be randomised for the PRB intervention or usual care.
6. Agree to release three pulmonary rehabilitation staff for training (not simultaneously) over 2 days with an additional half-day remote training
7. Agree that two pulmonary rehabilitation staff will undertake intervention delivery
8. Agree on the third pulmonary rehabilitation staff member to have a backup role in event of a colleague becoming ill or leaving the service during recruitment and LHW training.
9. At least two of three participating staff members to be a registered healthcare professional (HCP)
10. If the third member is a non-HCP then should be at least Band 4 NHS pay scale
11. All team members to have at least one year’s experience in pulmonary rehabilitation
Category B - Inclusion criteria of intervention site participating team members:
1. Aged 18 years or over
2. Be employed member of staff within the pulmonary rehabilitation service at the intervention site whether NHS or non-NHS service
3. Willing to undertake 2½ days of training to train, recruit, manage and support PRBs
4. Willing to manage and support PRBs over a nine-month period
5. Willing to take part in research activities including keeping accurate records
Category C - Inclusion criteria of pulmonary rehabilitation buddy volunteers:
1. Aged 18 years or over
2. COPD diagnosis and pulmonary rehabilitation completion within the previous year
3. Volunteer for the role
4. Willing to undertake training and be supervised by the pulmonary rehabilitation team
5. Willing to support at least 6 pulmonary rehabilitation patients over 9 months
6. Able to travel independently
7. Agree to use encrypted smartphones (after training) for recording conversations with supported patients
Category D - Inclusion criteria of participating patients:
1. Aged 18 years or over.
2. COPD diagnosis
3. Referred to pulmonary rehabilitation service
4. Medical Research Council (MRC) breathlessness score > 2
5. Consent to be randomised to intervention or usual care arm of the trial
6. Consent to receive telephone contact by PRB and to mee
Category A - Exclusion criteria of participating pulmonary rehabilitation sites:
1. Unable to join trial until after June 2023
2. Unable to identify at least three members of staff for the trial willing to consent to participation
3. Local trust R&D office unwilling to support the trial
Category B - Exclusion criteria of pulmonary rehabilitation site participating staff:
1. Will not be employed in their post for the duration of the trial at the site in question
Category C - Exclusion criteria of pulmonary rehabilitation buddy volunteers
1. Unable to participate for the duration of the trial at the site in question
2. Unable to travel independently to meet referred patients
3. Unable or unwilling to use a smart mobile phone
4. Unable to give valid consent
5. Failed DBS check
Category D - Exclusion criteria of participating patients
1. Poorly controlled angina on minimal exertion
2. Myocardial infarction in 6 weeks prior to commencement of the programme
3. Breathlessness as a result of cardiac disease.
4. Uncontrolled hypertension
5. Any medical problem that severely restricts exercise or compliance with the programme e.g. severe arthritis or dementia
6. Unable to give valid consent
7. Unable to join until after month 20 of the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method