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Evaluation of Diabetes and WELLbeing Programme (DWELL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04274660
Recruitment Status : Recruiting
First Posted : February 18, 2020
Last Update Posted : February 18, 2020
Sponsor:
Collaborators:
Interreg 2 Seas Mers Zeeen
Medway Community Healthcare
Blackthorn Trust
Arteveldehogeschool
Kinetic Analysis
Centre Hospitalier Douai
Information provided by (Responsible Party):
Canterbury Christ Church University

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Type 2 Diabetes Treated With Insulin Behavioral: DWELL (Diabetes and WELLbeing) Programme Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
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).

Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Diabetes and WELLbeing (DWELL) Programme for People With Type 2 Diabetes
Actual Study Start Date : September 8, 2017
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DWELL Intervention
People with type 2 diabetes participating in the 12-week DWELL (Diabetes and WELLbeing) Programme
Behavioral: DWELL (Diabetes and WELLbeing) Programme
12-week psychoeducational programme

No Intervention: DWELL non-intervention/Control
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



Primary Outcome Measures :
  1. Change in diabetes self-management as assessed by the Diabetes Self-Care Activities Measure [ Time Frame: Baseline, end of programme (3 months), 6 months after programme, 12 months after programme ]
    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.


Secondary Outcome Measures :
  1. Change in quality of life as assessed by the Short Form Health Survey (SF-12) [ Time Frame: Baseline, end of programme (3 months), 6 months after programme, 12 months after programme ]
    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)

  2. Change in levels of physical activity as assessed by the International Physical Activity Questionnaire (IPAQ) [ Time Frame: Baseline, end of programme (3 months), 6 months after programme, 12 months after programme ]
    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.

  3. Change in illness perception as assessed by the Illness Perception Questionnaire (IPQ-R) [ Time Frame: Baseline, end of programme (3 months), 6 months after programme, 12 months after programme ]
    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)

  4. Change in psychosocial self-efficacy as assessed by the Diabetes Empowerment Scale (DES-SF) [ Time Frame: Baseline, end of programme (3 months), 6 months after programme, 12 months after programme ]
    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.

  5. Change in eating behaviour as assessed by the Dutch Eating Behaviour Questionnaire (DEBQ) [ Time Frame: Baseline, end of programme (3 months), 6 months after programme, 12 months after programme ]
    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)

  6. Change in Body Mass Index (BMI) as assessed by height and weight [ Time Frame: Baseline, end of programme (3 months), 6 months after programme, 12 months after programme ]
    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

  7. Change in waist circumference [ Time Frame: Baseline, end of programme (3 months), 6 months after programme, 12 months after programme ]
    Changes in waist circumference will be measured and reported in cm where a lower measurement indicates an improvement for this outcome

  8. Change in average blood glucose levels as assessed by Hemoglobin A1c levels (HbA1c) [ Time Frame: Baseline, end of programme (3 months), 6 months after programme, 12 months after programme ]
    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

  9. Quality Adjusted Life Years (QALYs) [ Time Frame: 2.5 years ]
    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.

  10. Cost effectiveness [ Time Frame: 2.5 years ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04274660


Contacts
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Contact: Sharon Manship, MSc, MA 01634 894472 sharon.manship@canterbury.ac.uk

Locations
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Belgium
Arteveldehogeschool Recruiting
Ghent, Belgium, 9000
Contact: Ruben Vanbosseghem    +32 9 234 90 00    ruben.vanbosseghem@arteveldehs.be   
France
Centre Hosptalier Douai Recruiting
Douai, France, 59507
Contact: Marie Duezcalzada    +33 3 27 94 70 00    Marie.Duezcalzada@ch-douai.fr   
Netherlands
Kinetic Analysis Recruiting
Breda, 's-Hertogenbosch, Netherlands, 5211 DA
Contact: Maarten Gijssel    +31 6 21566017    mpe.gijssel@kinetic-analysis.com   
United Kingdom
Medway Community Healthcare Recruiting
Gillingham, Kent, United Kingdom, ME8 0PZ
Contact: Julie Webster    01634 334620    julie.webster1@nhs.net   
Blackthorn Trust Recruiting
Maidstone, Kent, United Kingdom, ME16 9AN
Contact: Nathalie Belmas    01622 828382    nathalie@blackthorn.org.uk   
Sponsors and Collaborators
Canterbury Christ Church University
Interreg 2 Seas Mers Zeeen
Medway Community Healthcare
Blackthorn Trust
Arteveldehogeschool
Kinetic Analysis
Centre Hospitalier Douai
Investigators
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Principal Investigator: Eleni Hatzidimitriadou, PhD Canterbury Christ Church University

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Responsible Party: Canterbury Christ Church University
ClinicalTrials.gov Identifier: NCT04274660    
Other Study ID Numbers: 2S01-058 DWELL
10065G00484 ( Other Identifier: Canterbury Christ Church University )
First Posted: February 18, 2020    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymous participant data relating to results in publications with regards to primary and secondary outcome measures will be shared through publishing platforms. Anonymised individual participant datasets may be shared via a suitable public data repository. A final report of the evaluation study will be made available via the Canterbury Christ Church University DWELL Project web page.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame:

It is anticipated that the study protocol will be published in a suitable academic journal by 31 December 2020. Individual participant data sets relating to the study will be made available via an appropriate data repository starting 6 months after formal publication of results.

The final report of the evaluation study will be available on Canterbury Christ Church University DWELL Project web page by 31 December 2020.

Access Criteria: Anonymised participant data sets relating to publications will be shared through the control measures of the publishing journals, such as full access to subscribers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases