Clinical trial NCT06419907: 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.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Patient Education as Topic
Keywords: health education
patient reported outcome measures
type 2 diabetes mellitus
patient education as topic
Lead sponsor: University of Liverpool
Sponsor class: OTHER
Collaborators: name: St Helens & Knowsley Teaching Hospitals NHS Trust
First posted: 2024-05-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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.

Primary outcomes:
measure: Change in self-care activities outcome measure (pre and post intervention) using the Diabetes Self-Management Questionnaire - Revised (DSMQ-R) scale
timeFrame: Measured at baseline and 3-4 months after intervention
Secondary outcomes:
measure: Change in diabetes distress (pre and post intervention) using the Problem Areas in Diabetes (PAID) tool
timeFrame: Measured at baseline and 3-4 months after intervention
measure: • Quality of life outcome measures (pre and post intervention) using the PROMIS-Global Health V1.2 scale
timeFrame: Measured at baseline and 3-4 months after intervention
Other outcomes:
measure: Deprivation
timeFrame: measured at baseline
measure: diabetes duration
timeFrame: measured at baseline
Locations:
city: St Helens
country: United Kingdom
facility: Diabetes Centre, St Helens Hospital
Study officials:
affiliation: University of Liverpool
name: Gemma A Lewis
role: PRINCIPAL_INVESTIGATOR
References: