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Differing Completion Rates of DIABETES Education on Patient Reported Outcomes

NCT06419907 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-09-22

Study results available
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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.

Conditions

  • Diabetes Mellitus, Type 2
  • Patient Education as Topic

Interventions

BEHAVIORAL

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

Structured diabetes self management education programme designed to support those with type 2 diabetes self care and prevent long term associated complications.

Sponsors & Collaborators

  • St Helens & Knowsley Teaching Hospitals NHS Trust

    collaborator OTHER

  • University of Liverpool

    lead OTHER

Principal Investigators

  • Gemma A Lewis · University of Liverpool

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-16
Primary Completion
2025-05-20
Completion
2025-05-20

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06419907 on ClinicalTrials.gov