Gemma Lewis, Greg Irving, John Wilding, Kevin Hardy
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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.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>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.</p>\n </section>\n \n <section>\n \n <h3> Ethics and Dissemination</h3>\n \n <p>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.</p>\n </section>\n \n <section>\n \n <h3> Trial Registration</h3>\n \n <p>Clinicaltrials.gov NCT06419907.</p>\n </section>\n </div>","PeriodicalId":11251,"journal":{"name":"Diabetic Medicine","volume":"41 12","pages":""},"PeriodicalIF":3.2000,"publicationDate":"2024-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/dme.15430","citationCount":"0","resultStr":"{\"title\":\"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\",\"authors\":\"Gemma Lewis, Greg Irving, John Wilding, Kevin Hardy\",\"doi\":\"10.1111/dme.15430\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Introduction</h3>\\n \\n <p>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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>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. 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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
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.
期刊介绍：
Diabetic Medicine, the official journal of Diabetes UK, is published monthly simultaneously, in print and online editions.
The journal publishes a range of key information on all clinical aspects of diabetes mellitus, ranging from human genetic studies through clinical physiology and trials to diabetes epidemiology. We do not publish original animal or cell culture studies unless they are part of a study of clinical diabetes involving humans. Categories of publication include research articles, reviews, editorials, commentaries, and correspondence. All material is peer-reviewed.
We aim to disseminate knowledge about diabetes research with the goal of improving the management of people with diabetes. The journal therefore seeks to provide a forum for the exchange of ideas between clinicians and researchers worldwide. Topics covered are of importance to all healthcare professionals working with people with diabetes, whether in primary care or specialist services.
Surplus generated from the sale of Diabetic Medicine is used by Diabetes UK to know diabetes better and fight diabetes more effectively on behalf of all people affected by and at risk of diabetes as well as their families and carers.”
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