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

ISRCTN	ISRCTN13051922
DOI	https://doi.org/10.1186/ISRCTN13051922
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	268185
Protocol serial number	CPMS: 43111; IRAS: 268185
Sponsors	King's College London, King's College Hospital NHS Foundation Trust
Funder	National Institute for Health Research

Submission date: 04/10/2019
Registration date: 08/10/2019
Last edited: 30/07/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Part of standard care for people with chronic obstructive pulmonary disease (COPD) is pulmonary rehabilitation: an exercise and education-focused intervention. People with COPD also living with frailty (1 in 5) who complete pulmonary rehabilitation experience significant improvements in health outcomes. However, they also have twice the odds of not completing this intervention compared to non-frail people with COPD. Integrating a comprehensive geriatric assessment at the start of pulmonary rehabilitation may better support people living with COPD and frailty to complete their rehabilitation and get connected with other services relevant to their needs. However, before testing this intervention in an effectiveness trial, the researchers need to address uncertainties around the intervention and trial delivery. The aim of this study is to determine the feasibility of conducting a randomised controlled trial of a comprehensive geriatric assessment for people with COPD and frailty starting pulmonary rehabilitation.

Who can participate?
Patients aged 50 or older with COPD and frailty who have been referred for outpatient pulmonary rehabilitation

What does the study involve?
Participants are randomly allocated to a control group (usual care) or intervention group (usual care plus comprehensive geriatric assessment). In addition to usual care, people in the intervention group receive a geriatrician-led multidimensional assessment of their needs, to develop individual recommendations and a care plan. This plan is actioned between the geriatrics and rehabilitation teams, in collaboration with local services. This may include, for example, a medication review, nutritional support, cognitive assessment, and/or an occupational therapy home assessment. All participants will complete a short physical assessment and questionnaires at baseline, 3 months post-randomisation and 6 months post-randomisation. Interviews will also be conducted with 10-15 patients and 5-10 staff.

What are the possible benefits and risks of participating?
This is a very low-risk study. Having an extra appointment and completing the questionnaires and the short physical test may be tiring for some. It is not known whether participants will benefit directly from participating. However, participants will be able to share their views and experiences in a way that will help to improve future care and research.

Where is the study run from?
1. King's College London & King's College Hospital NHS Foundation Trust (UK)
2. Guy's and St Thomas' NHS Foundation Trust (UK)
3. Royal Brompton and Harefield NHS Foundation Trust (UK)
4. Hillingdon Hospitals NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
December 2017 to February 2023

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Lisa Brighton
lisa.brighton@kcl.ac.uk

Contact information

Ms Lisa Brighton
Scientific

Cicely Saunders Institute of Palliative Care Policy and Rehabilitation
King’s College London
Bessemer Road
London
SE5 9PJ
United Kingdom

ORCID ID	0000-0003-0516-0102
Phone	+44 (0)20 7848 5041
Email	lisa.brighton@kcl.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled feasibility trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Breathe Plus: Feasibility trial of a comprehensive geriatric assessment for people with chronic obstructive pulmonary disease and frailty starting pulmonary rehabilitation
Study acronym	Breathe Plus
Study objectives	The study aim is to determine the feasibility of conducting a randomised controlled trial of an integrated comprehensive geriatric assessment for people with chronic obstructive pulmonary disease (COPD) and frailty starting pulmonary rehabilitation. Objectives are as follows: For people with COPD and frailty starting pulmonary rehabilitation: 1. To further define and understand the fidelity of implementation of a comprehensive geriatric assessment, including how it differs from and impacts on usual care 2. To explore the acceptability of the intervention for patients and staff 3. To refine the programme theory around the integration of a comprehensive geriatric assessment for this population 4. To estimate the appropriateness of the proposed eligibility criteria and recruitment processes in successfully retaining participants in the trial 5. To estimate the risk of contamination and unblinding in the trial 6. To explore the appropriateness and acceptability of proposed outcome measures and trial processes to patients and staff
Ethics approval(s)	Approved 26/09/2019, London City and East Research Ethics Committee (Bristol Research Ethics Committee Centre, Whitefriars, Level 3, Block B, Lewins Mead, Bristol, BS1 2NT, UK; Tel: +44 (0)2071048033/53; Email: nrescommittee.london-cityandeast@nhs.net), ref: 19/LO/1402
Health condition(s) or problem(s) studied	People living with chronic obstructive pulmonary disease and frailty
Intervention	Participants will be randomly allocated (1:1) to a control group (usual care) or an intervention group (usual care + comprehensive geriatric assessment). Participants will be randomised by minimisation (a hybrid system with a 20% simple randomisation element) using an independent web-based system created by the King’s College London Clinical Trial Unit. Intervention group: In addition to usual care, people in the intervention group will receive a geriatrician-led multidimensional assessment of their needs, in order to develop individual recommendations and a care plan. This will take place as a single appointment as soon as possible after the participant’s pre-pulmonary rehabilitation assessment. This plan will be actioned between the geriatrics and pulmonary rehabilitation teams, in collaboration with local services. This may include, for example, a medication review, nutritional support, cognitive assessment, and/or an occupational therapy home assessment. Follow-up data-collection timepoints will be at 3 months and 6 months post-randomisation.
Intervention type	Other
Primary outcome measure(s)	Feasibility outcomes include: 1. Percentage of comprehensive geriatric assessment recommendations that are implemented at 6 months 2. Acceptability of the intervention to patients and staff based on qualitative interviews 3. Percentage screened eligible, and percentage eligible recruited at trial completion 4. Percentage of participants retained at 3 months and at 6 months 5. Percentage of participants where contamination occurs (i.e. control group participants receiving a comprehensive geriatric assessment) at 6 months 6. Percentage of participants where data collection blinding is maintained at 6 months 7. Level of missing data on patient outcome questionnaires at baseline, 3 and 6 months
Key secondary outcome measure(s)	The following outcomes will be measured at baseline, 3 and 6 months: 1. Physical frailty assessed using short physical performance battery 2. Activities of daily living assessed using Manchester Respiratory Activities of Daily Living questionnaire 3. Health-related quality of life assessed using Chronic Respiratory Questionnaire 4. Health Status assessed using Euro-Qol 5D-5L 5. Anxiety and depression assessed using Hospital Anxiety and Depression Scale 6. Loneliness assessed using De Jong Gierveld Loneliness Scale 7. Service use assessed using Client Service Receipt Inventory
Completion date	28/02/2023

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	60
Total final enrolment	31
Key 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
Key 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
Date of first enrolment	01/11/2019
Date of final enrolment	30/04/2022

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

King's College London & King's College Hospital NHS Foundation Trust

Denmark Hill
London
SE5 9RS
United Kingdom

Guy's and St Thomas' NHS Foundation Trust

Great Maze Pond
London
SE1 9RT
United Kingdom

Royal Brompton and Harefield NHS Foundation Trust

Uxbridge
London
UB9 6JH
United Kingdom

Hillingdon Hospitals NHS Foundation Trust

Uxbridge
London
UB8 3NN
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		29/07/2024	30/07/2024	Yes	No
Protocol article		29/03/2021	06/04/2021	Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

30/07/2024: Publication reference added.
24/08/2023: The intention to publish date was changed from 31/08/2023 to 01/04/2024.
17/02/2023: The contact confirmed the record is up to date.
21/11/2022: The following changes have been made:
1. The final enrolment number has been added.
2. The overall trial end date has been changed from 30/11/2022 to 28/02/2023 and the plain English summary updated accordingly.
3. The intention to publish date has been changed from 31/05/2023 to 31/08/2023.
16/11/2021: The recruitment end date was changed from 01/11/2021 to 30/04/2022.
06/04/2021: Publication reference added.
21/09/2020: The following changes were made to the trial record:
1. The recruitment resumed.
2. The recruitment end date was changed from 01/11/2020 to 01/11/2021.
3. The overall end date was changed from 30/11/2021 to 30/11/2022.
4. The intention to publish date was changed from 31/05/2022 to 31/05/2023.
5. The plain English summary was updated to reflect these changes.
24/04/2020: Due to current public health guidance, recruitment for this study has been paused.
07/10/2019: Trial's existence confirmed by the NIHR.