Web-based support for self-management of diabetes
| ISRCTN | ISRCTN43587048 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43587048 |
| Secondary identifying numbers | 14189 |
- Submission date
- 26/03/2013
- Registration date
- 26/03/2013
- Last edited
- 25/01/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
University Road
Southampton
SO17 1BJ
United Kingdom
| I.Muller@soton.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Process of Care |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Developing and testing accessible web-based support for patient self-management of diabetes |
| Study objectives | 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(s) | NRES London Hampstead Committee,18/03/2013, ref: 13/LO/0316 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/07/2014 |
| Completion date | 01/07/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 120 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 250; UK Sample Size: 250 |
| Key inclusion criteria | 1. Adults (male & female; upper age limit 120 years; lower age limit 18 years) with Type 2 diabetes 2. Able to consent |
| Key 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 |
| Date of first enrolment | 01/07/2014 |
| Date of final enrolment | 01/07/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SO17 1BJ
United Kingdom
Sponsor information
University/education
Aldermoor Health Centre
Southampton
SO17 1BJ
England
United Kingdom
| Website | http://www.southampton.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/01ryk1543 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7
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 | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 23/01/2017 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
25/01/2017: Publication reference added.
30/04/2014: The overall trial end date was changed from 31/01/2015 to 01/07/2015.
17/04/2014: The overall trial start date was changed from 31/05/2013 to 01/07/2014.
