Differing Completion Rates of DIABETES Education on Patient Reported Outcomes (DIABETES-PRO)

September 1, 2025 updated by: University of Liverpool

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • St Helens, United Kingdom, WA93DA
        • Diabetes Centre, St Helens Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
100% of a face to face 6 hour structured diabetes self management education session
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.
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.
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.
Experimental: Group 3
10% of a face to face 6 hour structured diabetes self management education session. Total attendance will be 36 minutes.
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.
Active Comparator: Group 4
Will not attend a face to face 6 hour structured diabetes self management education session
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.

What is the study measuring?

Primary Outcome Measures

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

Diabetes self management questionnaire with good interrater reliability. Higher score indicates better self management. 20 item questionnaire, scale 0-10 with some items reversed scored. Total score added together and then divided by 60. Scores can range form 0-10. A higher score indicates better self management.

To calculate the change between baseline and follow up (4 months) we calculated the value at follow up minus baseline score.
3-4 months post baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Diabetes Distress (Pre and Post Intervention) Using the Problem Areas in Diabetes (PAID) Tool
Time Frame: Measured at baseline and 3-4 months after intervention

Validated tool measuring diabetes distress. Lower score indicates lower diabetes distress (better outcome). 20 item questionnaire, scale 0-100. Scores ≥40 indicate risk of emotional burnout.

To calculate the change between baseline and follow up (4 months) we calculated the value at follow up minus baseline score.
Measured at baseline and 3-4 months after intervention
• Mental Health Quality of Life Outcome Measures (Pre and Post Intervention) Using the PROMIS-Global Health V1.2 Scale
Time Frame: 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.

T-score <50 worse than average, >50 better than average.

To calculate the change between baseline and follow up (4 months) we calculated the value at follow up minus baseline score.
Measured at baseline and 3-4 months after intervention
Physical Health Quality of Life Outcome Measures (Pre and Post Intervention) Using the PROMIS-Global Health V1.2 Scale
Time Frame: 3-4 months post baseline

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.

T-score <50 worse than average, >50 better than average.

To calculate the change between baseline and follow up (4 months) we calculated the value at follow up minus baseline score.
3-4 months post baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deprivation
Time Frame: measured at baseline
Other preliminary data will explore whether deprivation has any impact on PROMs across the four groups.
measured at baseline
diabetes duration
Time Frame: measured at baseline
Other preliminary data will explore whether diabetes duration has any impact on PROMs across the four groups.
measured at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Liverpool

Collaborators

St Helens & Knowsley Teaching Hospitals NHS Trust

Investigators

  • Principal Investigator: Gemma A Lewis, University of Liverpool

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2024

Primary Completion (Actual)

May 20, 2025

Study Completion (Actual)

May 20, 2025

Study Registration Dates

First Submitted

May 9, 2024

First Submitted That Met QC Criteria

May 14, 2024

First Posted (Actual)

May 17, 2024

Study Record Updates

Last Update Posted (Actual)

September 22, 2025

Last Update Submitted That Met QC Criteria

September 1, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UoL001848
  • 337691 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All metadata records for the qualitative data will be uploaded onto the University research data repository. All records will be anonymised and identified by study number only in order to maintain confidentiality.

IPD Sharing Time Frame

Data will be available following the end of study and completion of associated publications and PhD thesis submission.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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