Evaluating a group-based maintenance self-management intervention for patients with COPD
| ISRCTN | ISRCTN30110012 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30110012 |
| Secondary identifying numbers | 109551; CPMS: 42162 |
- Submission date
- 03/05/2019
- Registration date
- 12/08/2019
- Last edited
- 25/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Chronic obstructive pulmonary disease describes a group of lung conditions that make it difficult to empty air out of the lungs because the airways are narrowed. Patients suffer from shortness of breath and tend to avoid activities which make them breathless, causing muscles to waste and weaken. An added problem is that patients often have repeated chest infections, some requiring hospital admission. This is detrimental for the patient and costly for the health service.
Pulmonary Rehabilitation is a package of supervised exercise and education which is known to improve physical and mental well-being, as well as preventing hospital
admissions in patients with COPD. However the benefits of rehabilitation do not last and patients talk about a feeling of 'abandonment' at the end of the programme. The aim of this research is to test a new maintenance (on-going support) programme for patients with COPD.
Who can participate?
COPD patients aged over 18 who have completed pulmonary rehabilitation in the past 4 weeks.
What does the study involve?
In this study, we will divide people into 2 groups at the end of rehabilitation. One group will receive best usual care including referral to a community exercise programme if wanted. The second group will receive best usual care plus the new maintenance programme. In this programme, patients will work through a booklet and attend group sessions for 12-months to gain support from patients and staff. All patients will do several tests over 12-months to measure physical and mental well-being. We will also interview patients and staff about their experiences of the programme.
What are the possible benefits and risks of participating?
If successful, the new maintenance programme has the potential to preserve and enhance the benefits of rehabilitation for the patient. This may reduce hospital admissions, saving the health service money.
This study was developed in response to patient feedback and with the support of patient representatives. The findings of the study will be announced at conferences, in publications and at patient groups.
Where is the study run from?
1. Glenfield General Hospital, UK
2. Harefield Hospital, UK
When is the study starting and how long is it expected to run for?
August 2019 to September 2023
Who is funding the study?
National Institute for Health Research (NIHR)
Who is the main contact?
1. Mr Khaled Alqahtani (public),
kada5@leicester.ac.uk
2. Dr Linzy Houchen-Wolloff (scientific),
linzy.houchen@uhl-tr.nhs.uk
Contact information
Public
Centre for Exercise and Rehabilitation Science
NIHR Leicester Biomedical Research Centre – Respiratory
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom
 ORCID ID |
0000-0001-5235-8467 |
|---|---|
| Phone | 01162582762 |
| kada5@leicester.ac.uk |
Scientific
Centre for Exercise and Rehabilitation Science
NIHR Leicester Biomedical Research Centre – Respiratory
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom
| ORCID ID |
0000-0003-4940-8835 |
|---|---|
| Phone | 01162582762 |
| linzy.houchen@uhl-tr.nhs.uk |
Scientific
Centre for Exercise and Rehabilitation Science (CERS)
NIHR Leicester Biomedical Research Centre (BRC)-Respiratory
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom
| ORCID ID |
0000-0002-9834-0366 |
|---|---|
| Phone | 0116 258 3388 |
| sally.singh@uhl-tr.nhs.uk |
Scientific
Royal Brompton and Harefield NHS Foundation Trust
Harefield Hospital
Hill End Road
Harefield
UB9 6JH
United Kingdom
| Phone | 020 3733 4165 |
|---|---|
| W.Man@rbht.nhs.uk |
Scientific
Mary Seacole Building
Brunel University London
Kingston Lane
Uxbridge
UB8 3PN
United Kingdom
| ORCID ID |
0000-0001-9067-599X |
|---|---|
| Phone | 020 3733 4165 |
| Claire.nolan@brunel.ac.uk |
Study information
| Study design | Prospective multicentre randomized controlled trial with blinded quantitative outcomes |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | https://www.leicestershospitals.nhs.uk/aboutus/departments-services/pulmonary-rehabilitation/research-and-development/current-studies/ |
| Scientific title | SPACE FOR COPD© delivered as a maintenance programme on Pulmonary Rehabilitation discharge: a randomised controlled trial evaluating the long-term effects on exercise tolerance and mental wellbeing |
| Study acronym | SPACE maintenance |
| Study objectives | Those completing the maintenance programme after Pulmonary Rehabilitation (PR) will have sustained improvements in endurance walking time at 12 months, compared to those receiving usual care alone, following PR. |
| Ethics approval(s) | Approved 10/10/2019, Leicester Central REC, (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS; +44 (0)207 104 8234; NRESCommittee.EastMidlands-LeicesterCentral@nhs.net), ref: 19/EM/0267 |
| Health condition(s) or problem(s) studied | Chronic obstructive pulmonary disease |
| Intervention | Current interventions as of 10/06/2021: Eligible and willing participants will be consented and then randomised to either usual care or the SPACE FOR COPD maintenance programme. Randomisation will be 1:1 into the two groups, and will be done using a concealed allocation web-based programme (sealedenvelope.com). Randomisation codes will be blocked per site, so that there are even numbers of intervention and control patients at each site, delivered in a timely appropriate manner (i.e. enough intervention participants recruited consecutively to one site to enable a group session to run). Those randomised to the intervention will be introduced to the SPACE FOR COPD© manual at their first group session. The SPACE FOR COPD© manual is divided into four stages and has 176 pages, providing an exercise programme and covering several education topics, with goal-setting text, case studies, and activities to encourage problem solving and support behaviour change. The text is interspersed with photographs, diagrams and ‘top tips’ boxes. There is a single A4 sheet action plan with a sputum colour chart to manage exacerbations. For the purposes of this trial, another single page insert will be devised to facilitate longer-term goal setting. The content has been approved by the Plain English Campaign and received the Crystal Mark for clarity of British English (appropriate for an eight year old to read). The manual will be introduced by Health Care Professionals (HCP), who have expertise in the management of COPD, the SPACE FOR COPD© programme and skills in motivational interviewing. HCPs will advise patients on how to use the manual and follow it independently at home. Participants will be expected to complete an exercise diary at home. Once at home, patients will have the opportunity to contact their HCP with questions via telephone. There will be follow-up maintenance group sessions (5-10 participants per group), at the recruiting centres or online based on a previously successful format. The aims of these group sessions are to discuss progress, address barriers, to increase motivation to maintain/ enhance healthy lifestyle behaviours and to encourage social support and not re-provide rehabilitation. Using motivational interviewing (MI) techniques, the sessions would involve the clinician facilitating the patients to identify barriers and facilitators to maintaining exercise, express empathy, support self-efficacy and roll with resistance. The teams at Leicester and London have worked together on previous projects and London are familiar with the SPACE FOR COPD programme. These groups will occur 4 times over 12-months, divided as follow: • At month 1 (introduction/ group responsibilities/ goal setting), • At months 4 (exacerbation management/ goal setting), • At month 7 (mood management and goal setting) and • At month 10 (question and answer/ keeping going). Each session will last for 2 hours at the recruiting centre or online. Patients will be sent reminders about group sessions by their preferred method (e.g. text, email, or letter). There will also be an embedded qualitative component of the trial. All eligible participants will be offered the chance to take part in the trial at the end of their Pulmonary Rehabilitation programme. Qualitative interviews will be performed in willing subjects (described later), at 12-months (or earlier if there is attrition to the programme). Previous interventions: Eligible and willing participants will be consented and then randomised to either usual care or the SPACE FOR COPD maintenance programme. Randomisation will be 1:1 into the two groups, and will be done using a concealed allocation web-based programme (sealedenvelope.com). Randomisation codes will be blocked per site, so that there are even numbers of intervention and control patients at each site, delivered in a timely appropriate manner (i.e. enough intervention participants recruited consecutively to one site to enable a group session to run). Those randomised to the intervention will be introduced to the SPACE FOR COPD© manual at their first group session. The SPACE FOR COPD© manual is divided into four stages and has 176 pages, providing an exercise programme and covering several education topics, with goal-setting text, case studies, and activities to encourage problem solving and support behaviour change. The text is interspersed with photographs, diagrams and ‘top tips’ boxes. There is a single A4 sheet action plan with a sputum colour chart to manage exacerbations. For the purposes of this trial, another single page insert will be devised to facilitate longer-term goal setting. The content has been approved by the Plain English Campaign and received the Crystal Mark for clarity of British English (appropriate for an eight year old to read). The manual will be introduced by Health Care Professionals (HCP), who have expertise in the management of COPD, the SPACE FOR COPD© programme and skills in motivational interviewing. HCPs will advise patients on how to use the manual and follow it independently at home. Participants will be expected to complete an exercise diary at home. Once at home, patients will have the opportunity to contact their HCP with questions via telephone. There will be follow-up maintenance group sessions (5-10 participants per group), at the recruiting centres based on a previously successful format. The aims of these group sessions are to discuss progress, address barriers, to increase motivation to maintain/ enhance healthy lifestyle behaviours and to encourage social support and not re-provide rehabilitation. Using motivational interviewing (MI) techniques, the sessions would involve the clinician facilitating the patients to identify barriers and facilitators to maintaining exercise, express empathy, support self-efficacy and roll with resistance. The teams at Leicester and London have worked together on previous projects and London are familiar with the SPACE FOR COPD programme. These groups will occur 4 times over 12-months, divided as follow: • At month 1 (introduction/ group responsibilities/ goal setting), • At months 4 (exacerbation management/ goal setting), • At month 7 (mood management and goal setting) and • At month 10 (question and answer/ keeping going). Each session will last for 2 hours at the recruiting centre and refreshments will be provided. Patients will be sent reminders about group sessions by their preferred method (e.g. text, email, or letter). There will also be an embedded qualitative component of the trial. All eligible participants will be offered the chance to take part in the trial at the end of their Pulmonary Rehabilitation programme. Qualitative interviews will be performed in willing subjects (described later), at 12-months (or earlier if there is attrition to the programme). |
| Intervention type | Behavioural |
| Primary outcome measure | Endurance walking distance at 12 months in those who have completed the maintenance programme compared to usual care (measured by Endurance Shuttle Walking Test). |
| Secondary outcome measures | At 12-months: 1. Maximum walking distance measured using incremental Shuttle Walking Test distance 2. Quality of life measured using EQ-5D 3. Anxiety and depression measured using the Hospital Anxiety and Depression Scale 4. Physical activity measured over 7 days using accelerometer devices (e.g. steps, calories, and MET levels). 5. Symptoms (breathlessness, fatigue, sputum production, cough, sleep, chest tightness) measured using the Chronic Respiratory Disease Questionnaire 6. Patient activation (knowledge, skills and confidence to manage COPD) measured using the Patient Activation Measure (PAM-13) questionnaire 7. Forced Expiratory Volume in 1 second (FEV1) measured using a spirometer. 8. Adherence to the SPACE FOR COPD maintenance programme in terms of sessions attended, completion of the programme and exercise diary entries. 9. Data for future health economic analysis in both groups; including hospital admissions, health care contacts, medication use and mortality collected from patient self-report. Qualitative outcomes: 10. To understand the patient experience of SPACE FOR COPD; to identify facilitators and barriers of the package to maintain health and well-being. 11. To work with staff, managers and commissioners involved in the delivery of SPACE FOR COPD as a maintenance option to explore how, if successful, this programme could be rolled-out more widely. |
| Overall study start date | 01/10/2018 |
| Completion date | 30/09/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 116 |
| Total final enrolment | 116 |
| Key inclusion criteria | 1. 18 years and older 2. Completed PR within the last 4 weeks 3. Clinical diagnosis of COPD 4. Able to read and write English to the age of an eight-year-old |
| Key exclusion criteria | 1. Significant disability which limits the daily physical activity |
| Date of first enrolment | 18/10/2019 |
| Date of final enrolment | 31/05/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Leicester
LE3 9QP
United Kingdom
Harefield
UB9 6JH
United Kingdom
Sponsor information
University/education
University Hospitals of Leicester NHS Trust
Research & Innovation Office
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
England
United Kingdom
| Phone | 01162584199 |
|---|---|
| David.Hetmanski@uhl-tr.nhs.uk | |
| Website | https://www.leicestershospitals.nhs.uk/contact/ |
"ROR" |
https://ror.org/02fha3693 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/03/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | In order to have a well-structured dissemination plan, we have adopted the Scientist Knowledge Translation Plan. It guides researchers through the stages of developing a dissemination strategy including clarifying ‘key messages’ identifying ways to transmit those messages and designing an evaluation plan. See here for details: http://ktdrr.org/training/webcasts/webcast5/webcast_ktplan_101013r.pdf Audiences for this trial are commissioning organisations (such as CCGs, STPs and NHS England), HCPs providing rehabilitation, patients and the public, external statutory organisations (such as the Department of Health, NICE, CLAHRCs), and Academia. They will be involved throughout the research process to better shape the outcomes and have it easily translated to the community at the end of the trial. The delivery of the trial outcomes will be communicated via face-to-face. Moreover, it will include, but not limited to, development of links with key organisations, use of electronic media, and publications including full and plain English summary reports. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from (Linzy Houchen-Wolloff, Linzy.Houchen@uhl-tr.nhs.uk, anonymised quantitative and qualitative data, after all publications are completed). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 25/04/2022 | 10/08/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Abstract results | 19/05/2024 | 24/07/2024 | No | No | |
| Basic results | 24/07/2024 | 25/07/2024 | No | No |
Additional files
Editorial Notes
25/07/2024: Basic results uploaded.
24/07/2024: Abstract added.
04/10/2023: The following changes were made:
1. The overall study end date was changed from 30/09/2022 to 30/09/2023 and the plain English summary has been updated accordingly.
2. The intention to publish date was changed from 15/01/2024 to 01/03/2024.
06/12/2022: A contact email was updated.
11/11/2022: The following changes were made to the trial record:
1. The intention to publish date was changed from 31/03/2023 to 15/01/2024.
2. The total final enrolment was added.
10/08/2022: Publication reference added.
08/02/2022: Ethics approval details updated, the recruitment start date was changed from 01/09/2019 to 18/10/2019.
10/06/2021: The following changes have been made:
1. The overall trial end date has been changed from 31/05/2022 to 30/09/2022 and the plain English summary has been updated accordingly.
2. Intention to publish date has been changed from 31/12/2022 to 31/03/2023.
3. The scientific contact has been updated.
4. The interventions have been updated.
18/01/2021: Recruitment to this study is no longer paused.
05/08/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/07/2020 to 31/05/2021.
2. The overall end date was changed from 30/09/2021 to 31/05/2022.
3. The intention to publish date was changed from 01/01/2022 to 31/12/2022.
4. The plain English summary was updated to reflect these changes.
15/04/2020: Due to current public health guidance, recruitment for this study has been paused.
05/11/2019: The ethics approval was added.
12/08/2019: Trial's existence confirmed by the NIHR.
