Abstract
Objective To determine the effectiveness of a web-based self-management programme for people with type 2 diabetes in improving glycaemic control and reducing diabetes-related distress. Methods and design Individually randomised two-arm controlled trial. Setting 21 general practices in England. Participants Adults aged 18 or over with a diagnosis of type 2 diabetes registered with participating general practices. Intervention and comparator Usual care plus either Healthy Living for People with Diabetes (HeLP-Diabetes), an interactive, theoretically informed, web-based selfmanagement programme or a simple, text-based website containing basic information only. Outcomes and data collection Joint primary outcomes were glycated haemoglobin (HbA1c) and diabetesrelated distress, measured by the Problem Areas in Diabetes (PAID) scale, collected at 3 and 12 months after randomisation, with 12 months the primary outcome point. Research nurses, blind to allocation collected clinical data; participants completed self-report questionnaires online. Analysis The analysis compared groups as randomised (intention to treat) using a linear mixed effects model, adjusted for baseline data with multiple imputation of missing values. Results Of the 374 participants randomised between September 2013 and December 2014, 185 were allocated to the intervention and 189 to the control. Final (12 month) follow-up data for HbA1c were available for 318 (85%) and for PAID 337 (90%) of participants. Of these, 291 (78%) and 321 (86%) responses were recorded within the predefined window of 10-14 months. Participants in the intervention group had lower HbA1c than those in the control (mean difference -0.24%; 95% CI -0.44 to -0.049; p=0.014). There was no significant overall difference between groups in the mean PAID score (p=0.21), but prespecified subgroup analysis of participants who had been more recently diagnosed with diabetes showed a beneficial impact of the intervention in this group (p = 0.004). There were no reported harms. Conclusions Access to HeLP-Diabetes improved glycaemic control over 12 months.
| Original language | English |
|---|---|
| Article number | e016009 |
| Number of pages | 12 |
| Journal | BMJ Open |
| Volume | 7 |
| Issue number | 9 |
| DOIs | |
| Publication status | Published - 1 Sept 2017 |
Funding
1Research Department of Primary Care and Population Health, University College London, London, UK 2Department of Public Health and Primary Care, Cardiovascular Epidemiology Unit, University of Cambridge, Cambridge, UK 3Department of Psychology, University of Bath, Bath, UK 4Population Health Research Institute, St George’s, University of London, London, UK 5Department of Health Sciences, University of York, York, UK 6Whittington Health, London, UK 7Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK 8Department of Clinical, Educational and Health Psychology, Centre for Behaviour Change, University College London, London, UK 9Department of Psychology, University of Southampton, Southampton, UK 10Faculty of Health Sciences, University of Southampton, Southampton, UK Acknowledgements We gratefully acknowledge the permission to use under license the validated behaviour change modules for weight loss (POWeR), alcohol reduction (DownYour Drink) and smoking cessation (StopAdvisor) and the diabetes module from Healthtalk online in HeLP-Diabetes. We are grateful to Orla O’Donnell for outstanding project management, Fiona Giles for administrative support, all our PPI who contributed to the development, maintenance and delivery of the intervention and/or the management and oversight of the trial, staff at the participating practices, Primary Care Research Network (PCRN) staff and all our participants. Funding This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (grant reference number RP-PG-0609-10135). Work conducted at the Cardiovascular Epidemiology Unit, University of Cambridge by MS and MH was additionally funded by the UK Medical Research Council (MR/ L003120/1), British Heart Foundation (RG/13/13/30194) and UK National Institute for Health Research Cambridge Biomedical Research Centre. AF is an NIHR Senior Investigator and receives funding from Oxford NIHR Biomedical Research Centre.
ASJC Scopus subject areas
- General Medicine
