NCT06419907Completed
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.
Source: ClinicalTrials.gov · Last updated 22 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 120 (actual)
- First submitted
- 9 May 2024
- Start date
- 16 May 2024
- Primary completion date
- 20 May 2025
- Lead sponsor
- University of Liverpool
- Diseases
- Type 2 diabetes
- NCT number
- NCT06419907
What you commit to
- Study type: Interventional
- Participants enrolled: 120
- From 16 May 2024 to the primary completion date, 20 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received structured education for their diabetes within the last 12 months either online or face to face.
Other illness
- A diagnosis of type 1, type 3c, Maturity-onset diabetes of the young (MODY) or gestational diabetes.
Other
- The following patients will be excluded entry into the study:
- Lack capacity to make an informed decision.
- Require 1:1 education support e.g., requires interpreter.
- Patients unable to attend for structured classroom education e.g., housebound.
Who the study is looking for
- All patients with a diagnosis of type 2 diabetes aged ≥18 years of age referred to the Diabetes centre who are able to provide informed consent and are responsible for daily management of their diabetes will be screened for entry into the study
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Diabetes Centre, St Helens Hospital Coordinator of this site? Confirm its status | St Helens | United Kingdom | Unknown status |
Related publications
- Randomised Controlled Feasibility Trial of Face-To-Face Diabetes Self-Management Education Shows High Completion Rates Are Needed to Improve Patient-Reported Outcomes.Diabetes Obes Metab · 2026 · PMID 42203730
This page is information, not medical advice. Discuss any trial with your doctor.