Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Ingrid Muller
ORCID ID
http://orcid.org/0000-0001-9341-6133
Contact details
University of Southampton
University Road
Southampton
SO17 1BJ
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
18909
Study information
Scientific title
Digital interventions to promote physical activity for people with chronic obstructive pulmonary disease (COPD)
Acronym
Study hypothesis
Can interactive digital materials enhance people with COPDs engagement and motivation to increase physical activity compared to standard written materials?
Ethics approval
Newcastle and North Tyneside REC, 24/04/2015, ref: 15/NE/0153
Study design
Feasibility randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Internet
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Chronic obstructive pulmonary disease
Intervention
An interactive digital intervention to promote physical activity will be compared to standard online written materials.
Intervention type
Other
Phase
Drug names
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 trial start date
15/07/2015
Overall trial end date
01/02/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients with COPD aged 18 years or more, who are able to consent.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 100; UK Sample Size: 100
Participant 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
Recruitment start date
01/10/2015
Recruitment end date
01/02/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Southampton
University Road
Southampton
SO17 1BJ
United Kingdom
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
Study results will be published in peer-reviewed journals and disseminated at academic conferences.
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list