Clinical trial NCT04274660: Evaluation of Diabetes and WELLbeing Programme
Official title: Evaluation of the Diabetes and WELLbeing (DWELL) Programme for People With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Type 2 Diabetes Treated With Insulin
Lead sponsor: Canterbury Christ Church University
Sponsor class: OTHER
Collaborators: name: Medway Community Healthcare
name: Blackthorn Trust
name: Arteveldehogeschool
name: Kinetic Analysis
name: Centre Hospitalier de Douai
name: The Health and Europe Centre
First posted: 2020-02-18
Enrollment: 594
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Participants will be invited to take part in the 12-week DWELL Programme (the intervention) based on their eligibility as per the inclusion criteria. They will all receive the psycho-social education element in addition to two motivational interviews. Each element will be evaluated alone and in combination.

The non-intervention group will be recruited in one of two ways - they will either be people with type 2 diabetes who do not wish to participate in the 12-week programme, or they are receiving routine care (which, for UK participants, is a locally commissioned 6-week programme).
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in diabetes self-management as assessed by the Diabetes Self-Care Activities Measure
timeFrame: Baseline, end of programme (3 months), 6 months after programme, 12 months after programme
Secondary outcomes:
measure: Change in quality of life as assessed by the Short Form Health Survey (SF-12)
timeFrame: Baseline, end of programme (3 months), 6 months after programme, 12 months after programme
measure: Change in levels of physical activity as assessed by the International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline, end of programme (3 months), 6 months after programme, 12 months after programme
measure: Change in illness perception as assessed by the Illness Perception Questionnaire (IPQ-R)
timeFrame: Baseline, end of programme (3 months), 6 months after programme, 12 months after programme
measure: Change in psychosocial self-efficacy as assessed by the Diabetes Empowerment Scale (DES-SF)
timeFrame: Baseline, end of programme (3 months), 6 months after programme, 12 months after programme
measure: Change in eating behaviour as assessed by the Dutch Eating Behaviour Questionnaire (DEBQ)
timeFrame: Baseline, end of programme (3 months), 6 months after programme, 12 months after programme
measure: Change in Body Mass Index (BMI) as assessed by height and weight
timeFrame: Baseline, end of programme (3 months), 6 months after programme, 12 months after programme
measure: Change in waist circumference
timeFrame: Baseline, end of programme (3 months), 6 months after programme, 12 months after programme
measure: Change in average blood glucose levels as assessed by Hemoglobin A1c levels (HbA1c)
timeFrame: Baseline, end of programme (3 months), 6 months after programme, 12 months after programme
measure: Quality Adjusted Life Years (QALYs)
timeFrame: 2.5 years
measure: Cost effectiveness
timeFrame: 2.5 years
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Arteveldehogeschool
city: Douai
country: France
facility: Centre Hosptalier Douai
city: Breda
country: Netherlands
facility: Kinetic Analysis
state: 's-Hertogenbosch
city: Gillingham
country: United Kingdom
facility: Medway Community Healthcare
state: Kent
city: Maidstone
country: United Kingdom
facility: Blackthorn Trust
state: Kent
Study officials:
affiliation: Canterbury Christ Church University
name: Eleni Hatzidimitriadou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hatzidimitriadou, E., Manship, S., Thompson, T., Morris, R., Moore, J. and Hulbert, S. 2023. Evalatuation study of the diabetes and welbeing (DWELL) - Report 1: Evaluation methodology. Canterbury, UK Canterbury Christ Church University.
citation: Hatzidimitriadou, E., Manship, S., Thompson, T., Morris, R., Moore, J., Hulbert, S. and Saloniki, E.-C. 2023. Evaluation study of diabetes and wellbeing (DWELL) - Report 2: Participant outcomes. Canterbury, UK Canterbury Christ Church University.
citation: Hatzidimitriadou, E., Manship, S., Thompson, T., Morris, R., Moore, J. and Hulbert, S. 2023. Evaluation study of Diabetes and Wellbeing (DWELL) - Report 3: Process evaluation. Canterbury Canterbury Christ Church University.
citation: Hatzidimitriadou, E., Manship, S., Thompson, T., Morris, R., Moore, J., Hulbert, S. and Saloniki, E.-C. 2023. Evaluation study of diabetes and wellbeing (DWELL) - Report 4: Workforce training and cost effectiveness. Canterbury. UK Canterbury Christ Church University.