Differing Completion Rates of DIABETES Education on Patient Reported Outcomes

Sponsor
University of Liverpool
Study ID
NCT06419907
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Type 2 Live Well (structured diabetes self management education programme) — BEHAVIORAL
    Structured diabetes self management education programme designed to support those with type 2 diabetes self care and prevent long term associated complications.

Study Details

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.

Key Dates

Start date
May 16, 2024
Status verified
Aug 2024
Primary completion
May 20, 2025
Completion
May 20, 2025

Study Design

Enrollment
120 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Group 1
    100% of a face to face 6 hour structured diabetes self management education session
  • Experimental: Group 2
    60% of a face to face 6 hour structured diabetes self management education session. Total attendance will be 3 hours 36 minutes.
  • Experimental: Group 3
    10% of a face to face 6 hour structured diabetes self management education session. Total attendance will be 36 minutes.
  • Active Comparator: Group 4
    Will not attend a face to face 6 hour structured diabetes self management education session

Primary Outcome Measure

Change in DSMQ Diabetes Self Management Questionnaire Measuring Diabetes Self Management Skills Pre and Post Intervention [ Time Frame: 3-4 months post baseline ]

Related Studies