Plain English Summary
Background and study aims
The aim of this study is to look for better ways to make web-pages to help people with diabetes. New web-pages have been developed and this study tests whether or not these are easier to use than standard information.
Who can participate?
Adults with type 2 diabetes
What does the study involve?
This study compares different types of web-pages for people with diabetes to see which is more helpful. To find this out, participants are randomly allocated into two groups and each group is given different web-pages to look at. This study takes about 30 minutes in total. Participants answer a questionnaire, are shown the web-pages, and afterwards fill in another questionnaire.
What are the possible benefits and risks of participating?
Taking part in this study will help identify better ways to make web-pages to help people with diabetes. The main risk is that participants may not like the web-pages.
Where is the study run from?
This study is organised by researchers at the University of Southampton, but the study will be carried out over the internet.
When is the study starting and how long is it expected to run for?
July 2014 to July 2015
Who is funding the study?
This study is part of a bigger project to improve the health of people with diabetes that is funded by the European Council.
Who is the main contact?
Dr Ingrid Muller
I.Muller@soton.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Ingrid Muller
ORCID ID
Contact details
University Road
Southampton
SO17 1BJ
United Kingdom
-
I.Muller@soton.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
14189
Study information
Scientific title
Developing and testing accessible web-based support for patient self-management of diabetes
Acronym
Study hypothesis
The aim of this work-package is to develop and trial web-based support suitable for people with lower levels of health literacy. In particular, it will examine the potential for web-based materials and tools to provide enhanced support (compared with standard written materials) by:
1. Tailoring the material to the particular needs, abilities and perspective of the user
2. Employing engaging audio-visual presentation and quiz formats
3. Providing simple interactive tools to support self-management tasks (e.g. guidance for choosing and planning lifestyle changes).
Ethics approval
NRES London Hampstead Committee,18/03/2013, ref: 13/LO/0316
Study design
Randomised; Interventional; Design type: Process of Care
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Quality of life
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Diabetes
Intervention
Current interventions as of 17/04/2014:
1. Interactive web-based materials: web-based-materials that are tailored, interactive and includes interactive tools
2. Static web-based materials: static version of the interactive web-based materials
Previous interventions:
1. Interactive web-based materials: web-based-materials that are tailored, interactive and includes interactive tools
2. Standard written materials: materials currently available
3. Static web-based materials: static version of the interactive web-based materials
Intervention type
Other
Phase
Phase I/II
Drug names
Primary outcome measure
Current primary outcome measures as of 17/04/2014:
User engagement, measured by intervention completion rates
Previous primary outcome measures:
Patient enablement; Timepoint(s): immediately post intervention
Secondary outcome measures
Current secondary outcome measures as of 17/04/2014:
1. Physical activity attitudes and intentions
2. Patient enablement
3. Website satisfaction
4. Diabetes and physical activity knowledge
All of these will be measured immediately post intervention
Previous secondary outcome measures:
1. Comprehension and satisfaction with materials; Timepoint(s): immediately post intervention
2. Health literacy; Timepoint(s): immediately post intervention
3. Intention to take part in physical activity; Timepoint(s): immediately post intervention
Overall trial start date
01/07/2014
Overall trial end date
01/07/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adults (male & female; upper age limit 120 years; lower age limit 18 years) with Type 2 diabetes
2. Able to consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 250; UK Sample Size: 250
Participant exclusion criteria
GPs will screen lists of potential participants to exclude individuals where there may be potential difficulties, for instance:
1. Severe mental health problems
2. Palliative care
3. Recent bereavement
4. Known opposition to involvement in research or inability to complete research measures, e.g. learning disability, inability to read/speak English
Recruitment start date
01/07/2014
Recruitment end date
01/07/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Road
Southampton
SO17 1BJ
United Kingdom
Sponsor information
Organisation
University of Southampton (UK)
Sponsor details
Aldermoor Health Centre
Southampton
SO17 1BJ
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Seventh Framework Programme
Alternative name(s)
EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28115299