COPD Pal Phase 2: A self-management app for Chronic Obstructive Pulmonary Disease. A pilot study
| ISRCTN | ISRCTN14530045 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14530045 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 235302 |
| Protocol serial number | IRAS 235302 |
| Sponsor | Hywel Dda University Health Board |
| Funder | Llywodraeth Cymru |
- Submission date
- 16/12/2020
- Registration date
- 17/12/2020
- Last edited
- 20/09/2023
- 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 (COPD) is the name for a group of lung conditions that cause breathing difficulties. COPD is responsible for 3 million deaths worldwide every year. In the UK, the condition costs the NHS over £500 million. Even though people with COPD need to use many healthcare services, they spend a very small amount of time (about 1%) of their time with a healthcare professional. The rest of the time, people with COPD need to self-manage their condition, which includes exercising, taking medication, and being aware of their symptoms. To encourage better self-management, Bond Digital Health have created a mobile phone app called COPD Pal that helps people with COPD keep track of their condition.
We have designed this study to help us to look at how people use COPD Pal and to look at how safe it is, so that we can design larger studies in the future.
Who can participate?
Adults over 18 years with COPD
What does the study involve?
Participants will be asked to use COPD Pal over 6 weeks. Participants will be asked to complete a questionnaire about self-management at the beginning and end of the study, we will record information about any COPD exacerbations they have had prior to and during the study and there will be a feedback form to fill in, asking questions about their experience of using COPD Pal.
What are the possible benefits and risks of participating?
Taking part in the study may help you with managing your COPD and associated symptoms. It will also help develop the app, which may help future patients.
There is no additional risk associated with participating in this study apart from the time needed to access the app. There is a small chance that you feel tired whilst using the app or completing the questionnaires. In which case, please take as many breaks as you need and take part at your own pace.
Where is the study run from?
Prince Philip Hospital (UK)
When is the study starting and how long is it expected to run for?
November 2019 to July 2020
Who is funding the study?
Llywodraeth Cymru (Welsh government) (UK)
Who is the main contact?
Sarah Rees, sarah.rees7@wales.nhs.uk
Contact information
Public
Hywel Dda University Health Board
Bryngwyn Mawr
Dafen
Llanelli
SA14 8QF
United Kingdom
| Phone | +44 (0)1554 899108 |
|---|---|
| sarah.rees7@wales.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre interventional non-randomized trial |
| Secondary study design | Non randomised study |
| Participant information sheet | ISRCTN14530045_PIS_V2.0_19Dec2019.doc |
| Scientific title | COPD Pal Phase 2: Assessing the uptake, engagement, and safety of a self-management app for Chronic Obstructive Pulmonary Disease. A pilot expediency study in a real-world setting |
| Study acronym | COPD Pal Phase 2 |
| Study objectives | This project aims to answer the research question: ‘For people with COPD, is a self-management mobile phone app safe and feasible and do people engage?’ Secondary objectives include: 1. Determine feasibility of large-scale trial based on recruitment to and completion of the study. 2. Determine user engagement and frequency of use of app 3. Safety of using the app in terms of impact on clinical outcomes 4. Usability and acceptability of using the app |
| Ethics approval(s) | Approved 13/01/2020, Wales REC 4, (Health and Care Research Wales Support and Delivery Centre, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, UK; +44 (0)2920 230457; Wales.REC4@wales.nhs.uk) ref: 19/WA/0347 |
| Health condition(s) or problem(s) studied | Chronic obstructive pulmonary disease |
| Intervention | Participants will be given a mobile smart phone with the COPD Pal app and instructed in its use. At baseline participants will be asked to complete the UCOPD questionnaire and data on COPD exacerbations (including hospital/GP attendances) and steroid/antibiotic use over the previous three months will be collected. Participants will be asked to use COPD Pal for 6 weeks before returning for a follow up visit where they will complete the UCOPD questionnaire, provide data on COPD exacerbations (including hospital/GP attendances) and use of steroids/antibiotics, and complete a feedback questionnaire. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | COPD Pal app |
| Primary outcome measure(s) |
1. Acceptable recruitment is defined as >50% of eligible people consenting to participate and follow-up data available for the self-management questionnaire (UCOPD) for >60% of enrolled participants at the end of the study period |
| Key secondary outcome measure(s) |
1. HRQoL measured using the COPD Assessment Test at baseline and weekly within the app for 6 weeks |
| Completion date | 27/07/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 30 |
| Total final enrolment | 25 |
| Key inclusion criteria | 1. Willing and able to sign informed consent 2. Clinical diagnosis of COPD as defined by GOLD, i.e. greater than 40 years old, ≥10 pack years smoking history, post-bronchodilator FEV1/FVC ratio of 0.7, with FEV1 less than 80% predicted 3. Life expectancy greater than 6 months |
| Key exclusion criteria | 1. Cognitive, visual, or motor impairment that would affect ability to see or use a smart phone 2. Current hospital inpatient or nursing home resident |
| Date of first enrolment | 20/01/2020 |
| Date of final enrolment | 16/02/2020 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Dafen
Llanelli
SA14 8QF
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 current data sharing plans for this study are unknown and will be available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 24/02/2021 | 11/11/2021 | Yes | No | |
| HRA research summary | 20/09/2023 | No | No | ||
| Participant information sheet | version V2.0 | 19/12/2019 | 17/12/2020 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version V2.0 | 19/12/2019 | 17/12/2020 | No | No |
Additional files
- ISRCTN14530045_PIS_V2.0_19Dec2019.doc
- uploaded 17/12/2020
- ISRCTN14530045_PROTOCOL_V2.0_19Dec2019.pdf
- uploaded 17/12/2020
Editorial Notes
20/09/2023: A link to the HRA research summary was added.
11/11/2021: Publication reference added.
17/12/2020: 1. Trial’s existence confirmed by Health and Care Research Wales.
2. Uploaded protocol (not peer reviewed) Version 2.0, 19 December 2019.
3. The participant information sheet was uploaded as an additional file.
