Differing Completion Rates of DIABETES Education on Patient Reported Outcomes

Diabetes Mellitus, Type 2 Clinical Trial

— DIABETES-PRO  

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06419907
• Other study ID #: UoL001848
• Secondary ID: 337691
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 15, 2024
• Est. completion date: May 15, 2026

Study information

• Verified date: May 2024
• Source: University of Liverpool
• Contact: Gemma A Lewis
• Phone: 01744646668
• Email: gemma.lewis[@]liverpool.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Structured diabetes self-management education (DSME) is internationally recommended for all people with newly diagnosed type 2 diabetes and is designed to support patients in self-managing their condition and prevent associated long-term complications. DSME is proven to be as effective as pharmacotherapy in preventing diabetes associated morbidity and premature mortality but attendance at both a national and local level remains poor. Local records suggest that of those that start DSME (9%) only 12.6% complete the programme. Attendance at DSME is currently benchmarked as having completed a registration form and had at least one active engagement with a programmes content, with 'completion' measured against ≥60% completion despite landmark trials reporting outcomes based on the full completion of a programme. Little is known, of the effectiveness of DSME on the psychological and emotional health of people with diabetes who complete less than the full DSME programme.

This feasibility study will test the impact of differing completion rates of a face-to-face DSME programme on patient reported outcomes measuring self-care, diabetes distress and quality of life in people with type 2 diabetes.

Using a quantitative approach, a single centre, randomised feasibility study will be conducted, aiming to recruit 120 eligible people with type 2 diabetes due to attend a secondary care diabetes clinic in the Northwest UK for specialist support, education and advice. Participants will be randomised into one of four 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. Normal clinical care will continue. Preliminary outcomes (psychometric questionnaire scores measuring ability to self-care, diabetes distress and health related quality of life) will be evaluated at baseline and 3-4 months post-intervention. Measures of feasibility (eligibility, recruitment and retention rates) will be reported.

Whilst the current literature evidences the clear benefits for people with type 2 diabetes attending DSME programmes, there is minimal understanding of the benefits of partial DSME completion on a person's ability to self-care despite national consensus accepting 60% attendance as 'completed'. The proposed research aims to test the feasibility of conducting a full randomised control trial to evaluate the effectiveness of DSME programmes on psychometric outcomes with differing completion rates

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: May 15, 2026
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

The following patients will be excluded entry into the study:

• Lack capacity to make an informed decision.

• A diagnosis of type 1, type 3c, Maturity-onset diabetes of the young (MODY) or gestational diabetes.

• Received structured education for their diabetes within the last 12 months either online or face to face.

• Require 1:1 education support e.g., requires interpreter.

• Patients unable to attend for structured classroom education e.g., housebound.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Patient Education as Topic

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Diabetes Centre, St Helens Hospital	St Helens

Sponsors (2)

Lead Sponsor	Collaborator
University of Liverpool	St Helens & Knowsley Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Deprivation	Other preliminary data will explore whether deprivation has any impact on PROMs across the four groups.	measured at baseline
Other	diabetes duration	Other preliminary data will explore whether diabetes duration has any impact on PROMs across the four groups.	measured at baseline
Primary	Change in self-care activities outcome measure (pre and post intervention) using the Diabetes Self-Management Questionnaire - Revised (DSMQ-R) scale	Validated tool testing ability to self care in type 2 diabetes. Higher score indicates better self care (better outcome).	Measured at baseline and 3-4 months after intervention
Secondary	Change in diabetes distress (pre and post intervention) using the Problem Areas in Diabetes (PAID) tool	Validated tool measuring diabetes distress. Lower score indicates lower diabetes distress (better outcome). Score range 0-100.	Measured at baseline and 3-4 months after intervention
Secondary	• Quality of life outcome measures (pre and post intervention) using the PROMIS-Global Health V1.2 scale	Validated tool measuring health related quality of life. The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.	Measured at baseline and 3-4 months after intervention

External Links

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