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
Year: 2024
Type: article
Study design: Study Protocol
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.
Source: Diabetic Medicine
DOI: 10.1111/dme.15430
Authors: Gemma Lewis, Greg Irving, John Wilding, Kevin Hardy
Institutions: University of Liverpool, St Helens Hospital, Edge Hill University
Language: English
Subfield: Endocrinology, Diabetes and Metabolism
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,640
OpenAlex ID: W4402268395
