Differing Completion Rates of DIABETES Education on Patient Reported Outcomes

NCT06419907 | Completed Results

• 2 other identifiers: UoL001848337691
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Patient Education as Topic

Keywords

health education; patient reported outcome measures; type 2 diabetes mellitus; patient education as topic

Outcome Measures

Primary Outcomes (1)

• Change in DSMQ Diabetes Self Management Questionnaire Measuring Diabetes Self Management Skills Pre and Post Intervention

  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 Outcomes (3)

• 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

• • Mental Health 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

• Physical Health Quality of Life Outcome Measures (Pre and Post Intervention) Using the PROMIS-Global Health V1.2 Scale

  3-4 months post baseline

Study Arms (4)

Group 1

ACTIVE COMPARATOR

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)

Group 2

EXPERIMENTAL

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)

Group 3

EXPERIMENTAL

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)

Group 4

ACTIVE COMPARATOR

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)

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.

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Liverpool: lead
• St Helens & Knowsley Teaching Hospitals NHS Trust: collaborator

Study Sites (1)

Diabetes Centre, St Helens Hospital

St Helens, WA93DA, United Kingdom

Location

Related Publications (1)

• Lewis G, Irving G, Wilding J, Hardy K. Evaluating the impact of differing completion rates of a face-to-face DIABETES self-management education programme on Patient Reported Outcome measures (DIABETES PRO): A feasibility trial protocol. Diabet Med. 2024 Dec;41(12):e15430. doi: 10.1111/dme.15430. Epub 2024 Sep 5.

  PMID: 39235931 DERIVED

Related Links

• Secure online environment for University of Liverpool Researchers to deposit, share and promote data and information

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Health Education

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

Recruitment from primary care was less effective than anticipated due to challenges in contacting eligible patients and low interest in DSME, consistent with national trends. While recruitment through specialty clinics was more successful, this approach alone lacks scalability for larger trials. Although overall retention and attendance were high, the study sample was predominantly white British, limiting the generalisability of findings to more diverse populations.

Results Point of Contact

• Title: Gemma Lewis
• Organization: University of Liverpool

gemma.lewis@liverpool.ac.uk

01744 646668

Study Officials

• Gemma A Lewis

  University of Liverpool

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 17, 2024
• Study Start: May 16, 2024
• Primary Completion: May 20, 2025
• Study Completion: May 20, 2025
• Last Updated: September 22, 2025
• Results First Posted: September 22, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available following the end of study and completion of associated publications and PhD thesis submission.

Locations

GB (1)