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Differing Completion Rates of DIABETES Education on Patient Reported Outcomes - Trial NCT06419907

Access comprehensive clinical trial information for NCT06419907 through Pure Global AI's free database. This phase not specified trial is sponsored by University of Liverpool and is currently Not yet recruiting. The study focuses on Diabetes Mellitus, Type 2,Patient Education as Topic. Target enrollment is 120 participants.

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NCT06419907
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behavioral
Trial Details
ClinicalTrials.gov โ€ข NCT06419907
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Differing Completion Rates of DIABETES Education on Patient Reported Outcomes
A Feasibility Study Evaluating the Impact of Differing Completion Rates of a Face-to-face Diabetes Self-management Education Programme on Patient Reported Outcome Measures.

Study Focus

Type 2 Live Well (structured diabetes self management education programme)

Interventional

behavioral

Sponsor & Location

University of Liverpool

St Helens, United Kingdom

Timeline & Enrollment

N/A

May 15, 2024

May 15, 2026

120 participants

Primary Outcome

Change in self-care activities outcome measure (pre and post intervention) using the Diabetes Self-Management Questionnaire - Revised (DSMQ-R) scale

Summary

The goal of this clinical feasibility trial is to test the impact of differing completion
 rates of a face-to-face diabetes self-management education programme on patient-reported
 outcomes measuring self-care, diabetes distress and quality of life in people with type 2
 diabetes. The main question it aims to answer is:
 
 1. What is the impact of differing completion rates of DSME programmes on ability to
 self-care (primary outcome), diabetes distress and health related quality of life in type 2
 diabetes.
 
 Researchers will compare participants across four study groups (Group 1 will receive a full
 DSME programme, Group 2 will receive 60%, Group 3 will receive 10% and Group 4 will have
 delayed education) to see if patients who attend minimal aspects (10%) of diabetes
 self-management education programmes gain clinically significant improvements in ability to
 self-care compared to those who do not attend and if the nationally accepted 60 % completion
 rate is as effective as 100% completion.
 
 Participants will:
 
 - complete three validated patient reported outcome measures testing self care activities,
 diabetes distress and health related quality of life.
 
 - Attend structured diabetes self-management education of differing completion rates
 dependent on the group they have been allocated to.
 
 - repeat the same three patient reported outcome measures 2-4 months after intervention.
 For participants in group 4 this will be 3-4 months from baseline.

ICD-10 Classifications

Type 2 diabetes mellitus
Type 2 diabetes mellitus with other specified complications
Type 2 diabetes mellitus without complications
Type 2 diabetes mellitus with unspecified complications
Type 2 diabetes mellitus with multiple complications

Data Source

ClinicalTrials.gov

NCT06419907

Non-Device Trial