Close
A randomised controlled trial of an interactive internet-based intervention compared with a standard information website to improve self-management skills in people with type 2 diabetes in primary care.
Chief Investigator: Elizabeth Murray
Statistician: Michael Sweeting & Mohammed Hudda
Trial Manager: Kingshuk Pal
Data Officer: Kerstin Modrow
The HeLP-Diabetes randomised controlled trial (RCT) is part of a programme of research that has involved developing a web based self-management programme for people with Type 2 Diabetes.
The RCT will:
- Determine the effect of HeLP-Diabetes on clinical outcomes and diabetes related emotional distress in people with Type 2 Diabetes.
- Determine the incremental cost-effectiveness of the intervention compared to usual care from the perspectives of health and personal social services and wider public sector resources.
The trial started in April 2013 and the research team will report their findings in 2016.
The research team have recruited 22 practices across England and have individually randomised 374 patients (in total) from these practices into an intervention group (who receive access to the interactive HeLP Diabetes website) or a control group (who receive access to a simple information only website). Patients have a baseline assessment and then are randomised to one of the trial websites and then receive training about the website. Participants are followed up for 12 months. The primary outcomes are change in Glycated haemoglobin (HbA1c) and diabetes related emotional distress scores (PAID) between baseline and 12 month follow up. Secondary outcomes include: change in blood pressure, BMI, lipids and anxiety and depression. A health economics analysis is included.
If you would like to find out more about the RCT please contact Kingshuk Pal, Trial Manager on 020 7794 0500 ext. 36323 or email k.pal@ucl.ac.uk
You can see the HeLP-Diabetes Statistical Analysis Plan by following the link below: