Breathe Plus: a trial to test the feasibility of including a comprehensive assessment at the start of lung rehabilitation for people living with chronic obstructive pulmonary disease and frailty
Not Applicable
Completed
- Conditions
- People living with chronic obstructive pulmonary disease and frailtyRespiratory
- Registration Number
- ISRCTN13051922
- Lead Sponsor
- King's College London
- Brief Summary
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33816606/ (added 06/04/2021) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39076524/ (added 30/07/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 31
Inclusion Criteria
1. Adults aged 50 years or older
2. Physician diagnosis of chronic obstructive pulmonary disease (in line with GOLD criteria)
3. Referred for outpatient pulmonary rehabilitation (in line with BTS guidelines)
4. Rockwood Clinical Frailty Scale score of 5 or more
Exclusion Criteria
1. Lacking mental capacity to provide informed consent
2. Unable to communicate verbally and respond to questions in written English (or unavailability of interpreters to enable this)
3. Currently receiving specialist geriatric services, or has in previous month, or due to in coming month
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility outcomes include:<br>1. Percentage of comprehensive geriatric assessment recommendations that are implemented at 6 months<br>2. Acceptability of the intervention to patients and staff based on qualitative interviews<br>3. Percentage screened eligible, and percentage eligible recruited at trial completion<br>4. Percentage of participants retained at 3 months and at 6 months<br>5. Percentage of participants where contamination occurs (i.e. control group participants receiving a comprehensive geriatric assessment) at 6 months<br>6. Percentage of participants where data collection blinding is maintained at 6 months<br>7. Level of missing data on patient outcome questionnaires at baseline, 3 and 6 months
- Secondary Outcome Measures
Name Time Method The following outcomes will be measured at baseline, 3 and 6 months:<br>1. Physical frailty assessed using short physical performance battery<br>2. Activities of daily living assessed using Manchester Respiratory Activities of Daily Living questionnaire<br>3. Health-related quality of life assessed using Chronic Respiratory Questionnaire<br>4. Health Status assessed using Euro-Qol 5D-5L<br>5. Anxiety and depression assessed using Hospital Anxiety and Depression Scale<br>6. Loneliness assessed using De Jong Gierveld Loneliness Scale<br>7. Service use assessed using Client Service Receipt Inventory