Evaluating the impact of differing completion rates of a face‐to‐face DIABETES self‐management education programme on Patient Reported Outcome measures ( DIABETES PRO ): A feasibility trial protocol

Gemma Lewis*, Greg Irving, John Wilding, Kevin Hardy

*Corresponding author for this work

Research output: Contribution to journalArticle (journal)peer-review

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Abstract

Introduction: Structured diabetes self‐management education (DSME) is internationally recommended for people with type 2 diabetes to support self‐management and to prevent associated long‐term complications. ‘Attendance’ at DSME is currently benchmarked as having completed a registration form and at least one active engagement with programme content, and ‘completion’ measured against ≥60% completion, despite landmark trials reporting outcomes based on the full completion of a programme. Little is known about the effectiveness of DSME on the psychological and emotional health of people with diabetes who complete less than the full DSME programme. We report a protocol for a single‐centre randomised feasibility study to assess the impact of differing completion rates of a face‐to‐face DSME programme on patient reported outcomes of self‐care, diabetes distress and quality of life in people with type 2 diabetes. Methods: A randomised feasibility study in 120 people with type 2 diabetes due to attend a secondary care diabetes clinic in the North West UK for DSME. Participants will be randomised into one of the four groups: Group 1 full DSME programme, Group 2 60%, Group 3 10% and Group 4 0% (delayed education). Psychometric questionnaire scores will be evaluated at baseline and 3–4 months post‐intervention. Measures of feasibility (eligibility, recruitment and retention rates) will be reported. Ethics and Dissemination: The DIABETES‐PRO study was approved by the London–Surrey Borders Research Ethics Committee (24/LO/0235). Results will be shared with study participants and published in peer‐reviewed journals. Trial Registration: Clinicaltrials.gov NCT06419907.
Original languageEnglish
Number of pages8
JournalDiabetic Medicine
Early online date5 Sept 2024
DOIs
Publication statusE-pub ahead of print - 5 Sept 2024

Keywords

  • patient education as topic
  • patient reported outcome measures
  • type 2 diabetes mellitus
  • health education

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