Condition category
Respiratory
Date applied
04/10/2019
Date assigned
08/10/2019
Last edited
08/10/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

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 November 2021

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

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

Trial website

Contact information

Type

Scientific

Primary contact

Ms Lisa Brighton

ORCID ID

http://orcid.org/0000-0003-0516-0102

Contact details

Cicely Saunders Institute of Palliative Care Policy and Rehabilitation
King’s College London
Bessemer Road
London
SE5 9PJ
United Kingdom
+44 (0)20 7848 5041
lisa.brighton@kcl.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS: 43111; IRAS: 268185

Study information

Scientific title

Breathe Plus: Feasibility trial of a comprehensive geriatric assessment for people with chronic obstructive pulmonary disease and frailty starting pulmonary rehabilitation

Acronym

Breathe Plus

Study hypothesis

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

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

Study design

Randomised controlled feasibility trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet.

Condition

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

Phase

Drug names

Primary outcome measure

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

Secondary outcome measures

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

Overall trial start date

01/12/2017

Overall trial end date

30/11/2021

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant 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

Recruitment start date

01/11/2019

Recruitment end date

01/11/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College London & King's College Hospital NHS Foundation Trust
Denmark Hill
London
SE5 9RS
United Kingdom

Trial participating centre

Guy's and St Thomas' NHS Foundation Trust
Great Maze Pond
London
SE1 9RT
United Kingdom

Trial participating centre

Royal Brompton and Harefield NHS Foundation Trust
Uxbridge
London
UB9 6JH
United Kingdom

Trial participating centre

Hillingdon Hospitals NHS Foundation Trust
Uxbridge
London
UB8 3NN
United Kingdom

Sponsor information

Organisation

King's College London

Sponsor details

James Clerk Maxwell Building
57 Waterloo Road
London
SE1 8WA
United Kingdom
+44 (0)20 7848 3224
reza.razavi@kcl.ac.uk

Sponsor type

University/education

Website

https://www.kcl.ac.uk/

Organisation

King's College Hospital NHS Foundation Trust

Sponsor details

R&I Office
King's College Hospital NHS Foundation Trust
161 Denmark Hill
London
SE5 8EF
United Kingdom
+44 (0)20 3299 1980
kch-tr.research@nhs.net

Sponsor type

Hospital/treatment centre

Website

https://www.kch.nhs.uk/research/setting-up/contact-research-office

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The researchers will use a broad strategy to disseminate their findings. This will include:
1. A plain English summary for participants who opt to receive this on their consent form
2. Sharing of scientific findings via open-access publications in journals and presentation at international meetings
3. Plain English summaries of findings for public bodies and websites (e.g. Applied Research Collaborative, British Lung Foundation)
4. Online pages about the project on our website (www.csi.kcl.ac.uk)
5. Use of social media (e.g. Twitter, YouTube, blogs)
6. Public engagement via talks and open public events at the Cicely Saunders Institute and our collaborating sites
7. Additional documents (e.g. protocol, participant information sheet, consent form) are available on reasonable request to the chief investigator

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

31/05/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

07/10/2019: Trial's existence confirmed by the NIHR.