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Evaluation of Diabetes and WELLbeing Programme (DWELL)

C

Canterbury Christ Church University

Status

Completed

Conditions

Type 2 Diabetes Treated With Insulin
Type 2 Diabetes

Treatments

Behavioral: DWELL (Diabetes and WELLbeing) Programme

Study type

Interventional

Funder types

Other

Identifiers

NCT04274660
10065G00484 (Other Identifier)
2S01-058 DWELL

Details and patient eligibility

About

This study evaluates the impact of 'DWELL' - a 12-week psycho-social education programme designed to help people with type 2 diabetes to better self-manage their condition. Up to 600 patients will participate in the programme, while a non-intervention group will receive routine care for their diabetes

Full description

The DWELL (Diabetes and WELLbeing) 12-week programme has been designed to incorporate specific elements of diabetes education and is underpinned by motivational interviewing to ensure it is tailored to individuals. Each of the four elements of the programme - education, nutrition, physical activity and wellbeing - have been carefully selected based on previous research into diabetes education. The Canterbury Christ Church University (CCCU) DWELL Team are responsible for the evaluation of DWELL, which will explore whether the combination of the programme elements is effective in improving self-management. Additionally, a process evaluation and cost effectiveness analysis will be conducted alongside participant outcomes

The programme will be delivered at five sites (two in the UK, one in Belgium, one in France, one in the Netherlands). The CCCU DWELL research team will be responsible for quality assurance, management and analysis of data, sample size assessment and reporting of adverse events. Each delivery site is responsible for adhering to their own Standard Operating Procedures.

Enrollment

594 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Clinical diagnosis of type 2 diabetes
  • Over the age of 18

Exclusion criteria

  • Under the age of 18
  • Pregnant women
  • Individuals who do not have the mental capacity to participate

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

594 participants in 2 patient groups

DWELL Intervention
Experimental group
Description:
People with type 2 diabetes participating in the 12-week DWELL (Diabetes and WELLbeing) Programme
Treatment:
Behavioral: DWELL (Diabetes and WELLbeing) Programme
DWELL non-intervention/Control
No Intervention group
Description:
People with type 2 diabetes who are receiving routine care from their GP and healthcare team. People with type 2 diabetes will continue to receive routine standard care. Routine care in this respect constitutes usual health and social care or any other nationally or locally commissioned education programmes

Trial contacts and locations

5

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Central trial contact

Sharon Manship, MSc, MA

Data sourced from clinicaltrials.gov

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