## Protocol Section
### Identification Module
**NCT ID:** NCT06419907

**Acronym:** DIABETES-PRO

**Brief Title:** Differing Completion Rates of DIABETES Education on Patient Reported Outcomes

**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.

#### Organization Study ID Info
**ID:** UoL001848
#### Organization
**Class:** OTHER
**Full Name:** University of Liverpool
#### Secondary ID Infos
**Domain:** IRAS
**ID:** 337691
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2026-05-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-11-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-15

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** St Helens & Knowsley Teaching Hospitals NHS Trust

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Liverpool

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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

### Conditions Module

**Conditions:**

- Diabetes Mellitus, Type 2

- Patient Education as Topic

**Keywords:**

- health education

- patient reported outcome measures

- type 2 diabetes mellitus

- patient education as topic

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 120

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 100% of a face to face 6 hour structured diabetes self management education session

**Intervention Names:**

- Behavioral: Type 2 Live Well (structured diabetes self management education programme)

**Label:** Group 1

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** 60% of a face to face 6 hour structured diabetes self management education session. Total attendance will be 3 hours 36 minutes.

**Intervention Names:**

- Behavioral: Type 2 Live Well (structured diabetes self management education programme)

**Label:** Group 2

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** 10% of a face to face 6 hour structured diabetes self management education session. Total attendance will be 36 minutes.

**Intervention Names:**

- Behavioral: Type 2 Live Well (structured diabetes self management education programme)

**Label:** Group 3

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Will not attend a face to face 6 hour structured diabetes self management education session

**Intervention Names:**

- Behavioral: Type 2 Live Well (structured diabetes self management education programme)

**Label:** Group 4

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group 1

- Group 2

- Group 3

- Group 4

**Description:** Structured diabetes self management education programme designed to support those with type 2 diabetes self care and prevent long term associated complications.

**Name:** Type 2 Live Well (structured diabetes self management education programme)

**Type:** BEHAVIORAL

### Outcomes Module

#### Other Outcomes

**Description:** Other preliminary data will explore whether deprivation has any impact on PROMs across the four groups.

**Measure:** Deprivation

**Time Frame:** measured at baseline

**Description:** Other preliminary data will explore whether diabetes duration has any impact on PROMs across the four groups.

**Measure:** diabetes duration

**Time Frame:** measured at baseline

#### Primary Outcomes

**Description:** Validated tool testing ability to self care in type 2 diabetes. Higher score indicates better self care (better outcome).

**Measure:** Change in self-care activities outcome measure (pre and post intervention) using the Diabetes Self-Management Questionnaire - Revised (DSMQ-R) scale

**Time Frame:** Measured at baseline and 3-4 months after intervention

#### Secondary Outcomes

**Description:** Validated tool measuring diabetes distress. Lower score indicates lower diabetes distress (better outcome). Score range 0-100.

**Measure:** 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

**Description:** 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.

**Measure:** • 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

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** gemma.lewis@liverpool.ac.uk

**Name:** Gemma A Lewis

**Phone:** 01744646668

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** St Helens

**Contacts:**

***Contact 1:***

- **Name:** Gemma A Lewis

- **Phone:** 01744646668

- **Role:** CONTACT

***Contact 2:***

- **Name:** Gemma A Lewis

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United Kingdom

**Facility:** Diabetes Centre, St Helens Hospital

**Zip:** WA93DA

#### Overall Officials

**Official 1:**

**Affiliation:** University of Liverpool

**Name:** Gemma A Lewis

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**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.

**Info Types:**

- STUDY_PROTOCOL

- SAP

**IPD Sharing:** YES

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

### References Module

#### See Also Links

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

**URL:** https://datacat.liverpool.ac.uk/

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes Mellitus

- ID: M7119

- Name: Diabetes Mellitus, Type 2

- Relevance: HIGH

- As Found: Diabetes Mellitus, Type 2

- ID: M21089

- Name: Facies

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000003924

- Term: Diabetes Mellitus, Type 2

### Misc Info Module

- Version Holder: 2024-05-31
