RESUMO
BACKGROUND: The purpose of this 6-month intervention pilot feasibility randomised trial was to test sending brief messages using mobile phones to promote self-management through taking medication as prescribed to people with type 2 diabetes. This was to inform the design and conduct of a future large-scale United Kingdom-based clinical trial and establish the feasibility of recruitment, the technology used, follow-up, and data collection. METHODS: A multicentre individually randomised, controlled parallel group trial in primary care, recruiting adults (≥ 35 years) with type 2 diabetes in England. Consenting participants were randomly allocated to receive short message system text messages up to four times a week, or usual care, for a period of 6 months; messages contained behavioural change techniques targeting medication use. The primary outcome was the rate of recruitment to randomisation of participants to the trial with a planned rate of 22 participants randomised per month. The study also aimed to establish the feasibility of follow-up at 6 months, with an aim of retaining more than 80% of participants. Data, including patient-reported measures, were collected at baseline and the end of the 6-month follow-up period, and a notes review was completed at 24 months. RESULTS: The trial took place between 26 November 2018 and 30 September 2019. In total 209 participants were randomly allocated to intervention (n = 103) or usual care (n = 106). The maximum rate of monthly recruitment to the trial was 60-80 participants per month. In total, 12,734 messages were sent to participants. Of these messages, 47 were identified as having failed to be sent by the service provider. Participants sent 2,864 messages to the automated messaging system. Baseline data from medical records were available for > 90% of participants with the exception of cholesterol (78.9%). At 6 months, a further HbA1c measurement was reported for 67% of participants. In total medical record data were available at 6 months for 207 (99.0%) of participants and completed self-report data were available for 177 (84.7%) of participants. CONCLUSION: The feasibility of a large-scale randomised evaluation of brief message intervention for people with type 2 diabetes appears to be high using this efficient design. Failure rate of sending messages is low, rapid recruitment was achieved among people with type 2 diabetes, clinical data is available on participants from routine medical records and self-report of economic measures was acceptable. TRIAL REGISTRATION: ISCTRN ISRCTN13404264. Registered on 10 October 2018.
RESUMO
OBJECTIVES: The aim of structured education for type 2 diabetes is to improve knowledge, skills and confidence in self-management. It is recommended in the UK for everyone who is newly diagnosed with type 2 diabetes. We developed an on-line programme called HeLP-Diabetes: Starting Out to address poor uptake of face-to-face structured education. The aim of this paper is to describe the intervention in line with the Template for Intervention Description and Replication guide, which calls for better reporting of interventions. METHODS: The Template for Intervention Description and Replication guide provided the item headings for the description. These included the theoretical underpinning, materials, procedures, providers, and mode of delivery. RESULTS: The programme was developed to meet NICE requirements for structured education and therefore followed a structured curriculum with four sessions covering content such as what diabetes is and how it is treated, possible complications, and how lifestyle changes can improve health. Content was delivered in text, images and video, and behaviour change techniques, self-assessment and feedback were used to help people target key health behaviours. The programme was delivered entirely online, but the team were available for support via telephone. Email feedback and reminders were sent. CONCLUSIONS: The TIDieR checklist allowed us to provide a clear structure for the description of the intervention. However, it could not capture the full complexity of the programme, and intervention developers considering using it in the future may find that it needs to be adapted to make it more specific to their intervention.
