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

IF 3.2 3区医学 Q2 ENDOCRINOLOGY & METABOLISM

Diabetic Medicine Pub Date : 2024-09-05 DOI:10.1111/dme.15430

Gemma Lewis, Greg Irving, John Wilding, Kevin Hardy

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引用次数: 0

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.

Abstract Image

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评估面对面 DIABETES 自我管理教育计划不同完成率对患者报告结果测量（DIABETES PRO）的影响：可行性试验方案。

导言：国际上建议 2 型糖尿病患者接受有组织的糖尿病自我管理教育（DSME），以支持自我管理并预防相关的长期并发症。目前，"参加 "糖尿病自我管理教育的基准是完成注册表和至少一次积极参与课程内容，而 "完成 "的衡量标准是完成率≥60%，尽管具有里程碑意义的试验报告结果是基于课程的全部完成。对于未完成全部 DSME 计划的糖尿病患者，DSME 对其心理和情绪健康的影响鲜为人知。我们报告了一项单中心随机可行性研究的方案，以评估面对面 DSME 项目的不同完成率对患者报告的 2 型糖尿病患者自我护理结果、糖尿病困扰和生活质量的影响：方法：对英国西北部一家二级医疗糖尿病诊所的 120 名 2 型糖尿病患者进行随机可行性研究。参与者将被随机分为四组：第一组为完整的 DSME 计划，第二组为 60%，第三组为 10%，第四组为 0%（延迟教育）。心理测量问卷得分将在基线和干预后 3-4 个月进行评估。将对可行性（合格率、招募率和保留率）进行评估：DIABETES-PRO 研究已获得伦敦-萨里边境研究伦理委员会的批准（24/LO/0235）。研究结果将与研究参与者共享，并在同行评审期刊上发表：试验注册：Clinicaltrials.gov NCT06419907。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Diabetic Medicine 医学-内分泌学与代谢

CiteScore

7.20

自引率

5.70%

发文量

229

审稿时长

3-6 weeks

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.”