A web-based self management programme (HeLP-Diabetes) for people with type 2 diabetes in primary care
| ISRCTN | ISRCTN02123133 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02123133 |
| Secondary identifying numbers | 13563 |
- Submission date
- 12/02/2013
- Registration date
- 14/02/2013
- Last edited
- 11/09/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
Type 2 diabetes is one of the commonest long term health conditions in the UK, affecting over 2 million adults. Many people with type 2 diabetes need help and support to live a healthy, happy life. The NHS recommends that every person with type 2 diabetes should have the opportunity to attend a self-management course on diabetes when first told they have diabetes, and once a year thereafter. But not everybody who needs these courses gets them - either because there are not enough courses locally, or because the courses are hard to get to, or because patients aren't offered them. An additional way of helping people with diabetes get the support and information they need to live a healthy, happy life is through the internet. We have developed two websites (one complex; one simple) offering help and support for people with type 2 diabetes. The aims of thise study are to see if either website improves people's wellbeing and clinical outcomes and if they are cost-effective compared to usual care.
Who can participate?
The HeLP-Diabetes study aims to recruit about 400 people with type 2 diabetes, aged 18 or over from General Practices across England.
What does the study involve?
Participants will be asked to complete a baseline assessment. This involves completing some questionnaires online and the practice nurse taking some clinical measurements like height, weight and blood pressure. The nurse will also take a blood sample to measure HbA1c and cholesterol levels. After this assessment has been completed participants will be randomly (by chance) allocated to use one of two websites. One website will be more complicated with lots of online tips and tools to help them manage their diabetes while the other will be simpler, focusing on the essential information everybody with type 2 diabetes needs to know. Participants will be asked to use the website as much or as little as they like for 12 months. Their use of the website (number of logins, pages visited) will be automatically recorded by the computer. After 3 months and 12 months they will be asked to complete the same questionnaires again and to see the practice nurse again to check their blood pressure and weight, and to take some blood tests (HbA1c and cholesterol). At the end of the study, HbA1c levels and measures of well-being will be compared in people asked to use the complicated website versus those asked to use the simpler, information only website.
What are the possible benefits and risks of participating?
Participants will have the opportunity to use a web-based education site (HeLP-Diabetes) for people with type 2 diabetes for a year. There is some research evidence to show that people who are given diabetes related information have better health outcomes than people who receive no information. It is very unlikely that participants will be at risk as a result of taking part in the study. The information on both websites has been developed by a team of doctors, nurses, dieticians and researchers. It reflects current best practice in the NHS.
Where is the study run from?
University College London in collaboration with The Whittington NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
It is anticipated that General Practice recruitment will start in March 2013 until September 2013. Participant recruitment will then start for another 6 months (September 2013 - March 2014). Participants will be enrolled on the study for one year.
Who is funding the study?
National Institute of Health Research Programme Grant for applied research (UK)
Who is the main contact?
Dr Charlotte Dack
c.dack@ucl.ac.uk
Contact information
Scientific
Department of Primary Care and Population Sciences
Hampstead Campus
Rowland Hill Street
London
NW3 2PF
United Kingdom
| c.dack@ucl.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Randomised controlled trial of a web-based self management programme (HeLP-Diabetes) for people with type 2 diabetes in primary care |
| Study acronym | HeLP-Diabetes |
| Study hypothesis | The trialists have developed a web-based self-management programme for people with type 2 diabetes (called HeLP-Diabetes). The aim is to determine the effectiveness and cost-effectiveness of HeLP-Diabetes through a randomised controlled trial in general practice. Participants will be randomised to using either the HeLP-Diabetes programme or a comparator website (information only). A pilot study will run for 6 months prior to the main RCT. |
| Ethics approval(s) | Camden and Islington National Research Ethics Committee, 06/12/2012, ref: 12LO1571 |
| Condition | Type 2 diabetes |
| Intervention | Comparator website: This will be an information only website created by the study team to compare with HeLP-Diabetes HeLP-Diabetes: HeLP-Diabetes is a web-based self-management programme we have developed for adults with type 2 diabetes Follow Up Length: 12 month(s) |
| Intervention type | Other |
| Primary outcome measure | Glycaemic control (HbA1c) and health-related quality of life, measured by the Problem Areas in Diabetes (PAID) scale Timepoint(s): Baseline, 3 months, 12 months |
| Secondary outcome measures | 1. Body mass index (BMI); Timepoint(s): Baseline, 3 months, 12 months 2. Completion of "9 essential processes"; Timepoint(s): 12 months 3. Cost of developing intervention; Timepoint(s): Baseline, 3 months, 12 months 4. Cost of supported access; Timepoint(s): Baseline, 3 months, 12 months 5. Costs of maintaining and updating the intervention; Timepoint(s): Baseline, 3 months, 12 months 6. Costs of training NHS staff in using intervention and training patients to use intervention; Timepoint(s): Baseline, 3 months, 12 months 7. Disability Management Self Efficacy Scale (DMSES); Timepoint(s): Baseline, 3 months, 12 months 8. Diabetes Treatment Satisfaction Questionnaire change version (DTSQc); Timepoint(s): 12 months 9. DTSQs; Timepoint(s): Baseline, 3 months, 12 months 10. EQ-5D to calculate Quality-Adjusted Life Years (QALYs); Timepoint(s): Baseline, 3 months, 12 months 11. Hospital Anxiety and Depression Scale (HADS); Timepoint(s): Baseline, 3 months, 12 months 12. Health service utilisation during the study period; Timepoint(s): Baseline, 3 months, 12 months 13. Systolic and diastolic blood pressure; Timepoint(s): Baseline, 3 months, 12 months 14. Total cholesterol and HDL; Timepoint(s): Baseline, 3 months, 12 months 15. Use of website; Timepoint(s): Throughout |
| Overall study start date | 01/03/2013 |
| Overall study end date | 01/09/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | UK Sample Size: 398 |
| Participant inclusion criteria | 1. Adults, male and female, aged 18 or over 2. With type 2 diabetes |
| Participant exclusion criteria | 1. Unable to provide informed consent, e.g. due to psychosis, dementia or severe learning difficulties 2. Terminally ill with less that 12 months life expectancy 3. Unable to use a computer due to severe mental or physical impairment 4. Insufficient mastery of spoken English to use the intervention 5. Current participation in a trial of an alternative self-management programme |
| Recruitment start date | 01/03/2013 |
| Recruitment end date | 01/03/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
NW3 2PF
United Kingdom
Sponsor information
University/education
c/o Dave Wilson
Joint Research Office (part of the Research Support Centre)
UCL
1st Floor, Maple House - Suite B
149 Tottenham Court Road
London
W1T 7DN
England
United Kingdom
| david.wilson@ucl.ac.uk | |
| Website | http://www.ucl.ac.uk |
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Government
No information available
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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 29/12/2015 | Yes | No | |
| Results article | results | 27/09/2017 | Yes | No | |
| Results article | cost-effectiveness results | 08/06/2018 | Yes | No | |
| Results article | results | 01/09/2018 | Yes | No |
Editorial Notes
11/09/2018: Publication reference added.
11/06/2018: Publication reference added.
19/10/2017: Publication reference added.
