Differing Completion Rates of DIABETES Education on Patient Reported Outcomes

Not Applicable

• Conditions: Diabetes Mellitus, Type 2; Patient Education as Topic
• Interventions: Behavioral: Type 2 Live Well (structured diabetes self management education programme)

• Registration Number: NCT06419907
• Lead Sponsor: University of Liverpool

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2024-05-09
• Study First Submitted QC: 2024-05-14
• Study Start: 2024-05-16
• Study First Posted: 2024-05-17
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-21
• Primary Completion: 2025-11-01
• Study Completion: 2026-05-15

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 120

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Type 2 Live Well (structured diabetes self management education programme)	100% of a face to face 6 hour structured diabetes self management education session
Group 2	Type 2 Live Well (structured diabetes self management education programme)	60% of a face to face 6 hour structured diabetes self management education session. Total attendance will be 3 hours 36 minutes.
Group 3	Type 2 Live Well (structured diabetes self management education programme)	10% of a face to face 6 hour structured diabetes self management education session. Total attendance will be 36 minutes.
Group 4	Type 2 Live Well (structured diabetes self management education programme)	Will not attend a face to face 6 hour structured diabetes self management education session

Primary Outcome Measures

Name	Time	Method
Change in self-care activities outcome measure (pre and post intervention) using the Diabetes Self-Management Questionnaire - Revised (DSMQ-R) scale	Measured at baseline and 3-4 months after intervention	Validated tool testing ability to self care in type 2 diabetes. Higher score indicates better self care (better outcome).

Secondary Outcome Measures

Name	Time	Method
• Quality of life outcome measures (pre and post intervention) using the PROMIS-Global Health V1.2 scale	Measured at baseline and 3-4 months after intervention	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.
Change in diabetes distress (pre and post intervention) using the Problem Areas in Diabetes (PAID) tool	Measured at baseline and 3-4 months after intervention	Validated tool measuring diabetes distress. Lower score indicates lower diabetes distress (better outcome). Score range 0-100.

Trial Locations

Locations (1)

Diabetes Centre, St Helens Hospital; 🇬🇧 St Helens, United Kingdom