NCT06419907

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.
University of Liverpool·ClinicalTrials.gov·behavioralNot yet recruiting
View on ClinicalTrials.gov
Study focus
Drug/Device/Intervention
Type 2 Live Well (structured diabetes self management education programme)
Study type
Interventional
Intervention type
behavioral
Sponsor & location
Primary sponsor
University of Liverpool
Location
St Helens, United Kingdom
Timeline & enrollment
Phase
N/A
Start date
May 15, 2024
End date
May 15, 2026
Enrollment
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 mellitusType 2 diabetes mellitus with other specified complicationsType 2 diabetes mellitus without complicationsType 2 diabetes mellitus with unspecified complicationsType 2 diabetes mellitus with multiple complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06419907
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.