Evaluation of Diabetes and WELLbeing Programme

Study Overview
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Brief Summary
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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 800 patients will participate in the programme, while a non-intervention group will receive routine care for their diabetes

Detailed Description
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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.

Official Title
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Evaluation of the Diabetes and WELLbeing (DWELL) Programme for People With Type 2 Diabetes

Conditions
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Type 2 Diabetes, Type 2 Diabetes Treated With Insulin

Intervention / Treatment
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* Behavioral: DWELL (Diabetes and WELLbeing) Programme


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Interventional 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DWELL Intervention<br>People with type 2 diabetes participating in the 12-week DWELL (Diabetes and WELLbeing) Programme | Behavioral: DWELL (Diabetes and WELLbeing) Programme<br>* 12-week psychoeducational programme<br>|
| No Intervention: DWELL non-intervention/Control<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in diabetes self-management as assessed by the Diabetes Self-Care Activities Measure | Changes in self-management and self-care will be measured using the Diabetes Self-Care Activities Measure at four time points. The SDSCA assesses aspects of the diabetes regimen. Higher scores indicate greater taking of prescribed medication and undertaking footcare regime. | Baseline, end of programme (3 months), 6 months after programme, 12 months after programme | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life as assessed by the Short Form Health Survey (SF-12) | Changes in health related quality of life will be measured using the Short Form Health Survey (SF-12) at four time points. SF-12 measures eight health domains to assess physical health (min 6, max 20 - higher scores indicate better physical health) and mental health (min 6, max 24 - higher scores indicate better mental health) | Baseline, end of programme (3 months), 6 months after programme, 12 months after programme | 
| Change in levels of physical activity as assessed by the International Physical Activity Questionnaire (IPAQ) | Changes in levels of physical activity will be measured using the International Physical Activity Questionnaire (IPAQ) at four time points. IPAQ collects information on physical activity participation in three domains as well as sedentary behaviour. There is no min or max score - participants indicate how much exercise they do per week which is converted into MET minutes. Greater MET minutes indicate greater levels of physical activity. | Baseline, end of programme (3 months), 6 months after programme, 12 months after programme | 
| Change in illness perception as assessed by the Illness Perception Questionnaire (IPQ-R) | Changes in perception and attitudes towards type 2 diabetes will be measured using the Illness Perception Questionnaire (IPQ-R) at four time points. IPQ-R measures an individual's beliefs and feelings about their illness. The IPQ-R is split into 7 sub-scales: Timeline (min 6, max 30 - higher scores indicate participants expect diabetes to last longer); Consequences (min 6, max 30 - higher scores indicate perceived worse consequences of diabetes); Personal Control (min 6, max 30 - higher scores indicate higher perceived control over diabetes); Treatment Control (min 5, max 25 - higher scores indicate higher perceived effect of treatment); Illness Coherence (min 5, max 25 - higher scores indicate better perceived understanding of illness); Timeline Cyclical (min 4, max 20 - higher scores indicate greater unpredictability of diabetes symptoms); Emotional Representations (min 6, max 30 - higher scores indicate more negative emotions associated with diabetes) | Baseline, end of programme (3 months), 6 months after programme, 12 months after programme | 
| Change in psychosocial self-efficacy as assessed by the Diabetes Empowerment Scale (DES-SF) | Changes in self-efficacy will be measured using the Diabetes Empowerment Scale (DES-SF) at four time points. DES-SF measures changes in psychosocial self-efficacy. Minimum score is 8, max is 40. Higher scores indicate greater sense of empowerment to self-manage condition. | Baseline, end of programme (3 months), 6 months after programme, 12 months after programme | 
| Change in eating behaviour as assessed by the Dutch Eating Behaviour Questionnaire (DEBQ) | Changes in eating behaviour will be measured using the Dutch Eating Behaviour Questionnaire (DEBQ) at four time points. DEBQ assesses three distinct eating behaviours in adults: Emotional Eating (min 10, max 50 - higher scores indicate the patient makes more effort to restrain eating) ; External Eating (min 13, max 65 - higher scores indicate patient eats more for emotional reasons); Restrained Eating (min 10, max 50 - higher scores indicate more motivated to eat by external factors, such as the smell and look of food) | Baseline, end of programme (3 months), 6 months after programme, 12 months after programme | 
| Change in Body Mass Index (BMI) as assessed by height and weight | Changes in height and weight will be combined to report BMI in kg/m^2 where a lower score indicates an improvement for this outcome | Baseline, end of programme (3 months), 6 months after programme, 12 months after programme | 
| Change in waist circumference | Changes in waist circumference will be measured and reported in cm where a lower measurement indicates an improvement for this outcome | Baseline, end of programme (3 months), 6 months after programme, 12 months after programme | 
| Change in average blood glucose levels as assessed by Hemoglobin A1c levels (HbA1c) | Changes in blood glucose (sugar) levels will be assessed by reports of HbA1c blood test results, where a lower score indicates improvement in this outcome | Baseline, end of programme (3 months), 6 months after programme, 12 months after programme | 
| Quality Adjusted Life Years (QALYs) | Health related quality of life will be measured using the EuroQol Five Dimensions (EQ-5D-5L). The EQ-5D contains 5 sub-scales with a min score of 1 and max score of 3. Higher scores indicate worse mobility, worse ability to self-care, worse ability to perform usual activities, more pain and more anxiety. Utility values will also be multiplied by the time spent in each state to generate QALYs. 1 QALY is equivalent to perfect health while less than perfect health carries a QALY between 0 and 1. The higher the number of QALYs gained the better the health outcomes for people living with type 2 diabetes. | 2.5 years | 
| Cost effectiveness | The cost of Quality Adjusted Life Years (QALYs) of people with type 2 diabetes in the intervention group will be compared with the control group to illustrate cost effectiveness of the DWELL Programme | 2.5 years |