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 self-management programme or a simple, text-based website containing basic information only.
Outcomes and data collection Joint primary outcomes were glycated haemoglobin (HbA1c) and diabetes-related 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.
Trial registration number ISRCTN02123133.
- self care
- diabetes mellitus,type 2
- primary care
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Contributors EM, MS, CD, KP, MB, AF, SM, LY, CM, SP, FS and DP all contributed to the design of the trial. MS, assisted by MH and KM, designed the statistical analysis plan and undertook the analysis. SP and JL designed and undertook the health economic aspects of the trial. EM, KP, CD, JR, GA, LY and SM contributed to the development and delivery of the intervention. MK contributed PPI input. EM and MS wrote the first draft of the paper; all authors commented on this draft and approved the final version.
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.
Disclaimer The views expressed are those of the author(s)and not necessarily those of the NHS, the NIHR or the Department of Health. The funder had no role in the study design, data collection, data analysis, data interpretation or writing of the report. All authors had full access to all the data in the study and can take responsibility for the integrity of the data and data analysis. The lead author had final responsibility for the decision to submit for publication, affirms that the manuscript is an honest, accurate and transparent account of the study being reported; that no important aspects of the study have been omitted; and that there were no significant discrepancies from the published protocol.
Competing interests EM is the managing director of a not-for-profit community interest company established to disseminate HeLP-Diabetes across the NHS.
Patient consent Detail has been removed from this case description/these case descriptions to ensure anonymity. The editors and reviewers have seen the detailed information available and are satisfied that the information backs up the case the authors are making.
Ethics approval Camden and Islington National Research Ethics Service Committee.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Patient-level data, the full dataset and statistical code are available from the corresponding author. Consent for data sharing was not obtained from participants, but the potential benefits of sharing these data outweigh the potential harms as the data are anonymised.
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