Digital interventions for chronic obstructive pulmonary disease (COPD)
| ISRCTN | ISRCTN75958874 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75958874 |
| Secondary identifying numbers | 18909 |
- Submission date
- 26/08/2015
- Registration date
- 27/08/2015
- Last edited
- 19/03/2018
- 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 used to refer to a number of progressive devastating and debilitating lung diseases, which includes chronic bronchitis, emphysema and chronic obstructive airways disease. People that have COPD typically feel breathless after physical activity, have a persistent cough with phlegm and suffer frequently from chest infections. There is no cure for the condition, but making lifestyle changes (such as stopping smoking) and taking medications (inhalers and/or tablets) can alleviate symptoms. Staying physically active is vital for successful self-management of COPD, although people with COPD often find that they are not as physically active as they were. This research will answer key questions regarding how best to develop and deliver an accessible digital health intervention aimed at motivating people with COPD to increase their level of physical activity, building on our previous experience of developing web-based materials for people with varied levels of literacy, health literacy and computer skills.
Who can participate?
People with COPD from participating GP practices in the Southampton area.
What does the study involve?
This study compares different types of online materials for people with COPD to see which is more helpful. To find this out, participants are randomly allocated into one of two groups. Those in group 1 are given access to an interactive web-based programme. Those in group 2 are given access to standard online written materials. All participants are then assessed in terms of their attitude towards physical activity and whether they will do more, how easy they found using the website, how much they liked using the website and also how much they know about their condition.
What are the possible benefits and risks of participating?
We don’t expect the study to involve any risk to participants. They may not like the website, but they will be able to log off or close the browser if that is the case. Potential benefits are that participants may learn new information about COPD and be motivated to improve their self-management.
Where is the study run from?
University of Southampton (UK)
When is the study starting and how long is it expected to run for?
July 2015 to February 2016
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Ingrid Muller
Contact information
Scientific
University of Southampton
University Road
Southampton
SO17 1BJ
United Kingdom
 ORCID ID |
0000-0001-9341-6133 |
|---|
Study information
| Study design | Feasibility randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Digital interventions to promote physical activity for people with chronic obstructive pulmonary disease (COPD) |
| Study objectives | Can interactive digital materials enhance people with COPDs engagement and motivation to increase physical activity compared to standard written materials? |
| Ethics approval(s) | Newcastle and North Tyneside REC, 24/04/2015, ref: 15/NE/0153 |
| Health condition(s) or problem(s) studied | Chronic obstructive pulmonary disease |
| Intervention | An interactive digital intervention to promote physical activity will be compared to standard online written materials. |
| Intervention type | Other |
| Primary outcome measure | Attitudes and intentions to physical activity; Timepoint(s): immediately post-intervention |
| Secondary outcome measures | 1. User engagement 2. Enablement 3. Website satisfaction 4. COPD knowledge |
| Overall study start date | 15/07/2015 |
| Completion date | 01/02/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 100; UK Sample Size: 100 |
| Key inclusion criteria | Patients with COPD aged 18 years or more, who are able to consent. |
| Key exclusion criteria | 1. Inability to read / speak English 2. Potential difficulties, for instance; severe mental health problems, palliative care, recent bereavement, known opposition to involvement in research or inability to complete research measures |
| Date of first enrolment | 01/10/2015 |
| Date of final enrolment | 01/02/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Southampton
SO17 1BJ
United Kingdom
Sponsor information
University/education
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
England
United Kingdom
"ROR" |
https://ror.org/01ryk1543 |
|---|
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 | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Study results will be published in peer-reviewed journals and disseminated at academic conferences. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
19/03/2018: No publications found, verifying study status with principal investigator.
