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Type 2 DiabetesDWELLNCT04274660

Evaluation of Diabetes and WELLbeing Programme

A study testing DWELL (Diabetes and WELLbeing) Programme in people with Type 2 Diabetes and Type 2 Diabetes Treated With Insulin, run by Canterbury Christ Church University at 5 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
DWELL (Diabetes and WELLbeing) Programme
Could I receive a placebo?
No, everyone receives an active treatment
How many people
594 participants
Where
5 sitesin 4 countries
Study dates
8 Sep 2017to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

5 sites in 4 countries.

5 sites in 4 countries

United Kingdom2 sites

  • Medway Community Healthcare

    Gillingham, Kent, ME8 0PZ

  • Blackthorn Trust

    Maidstone, Kent, ME16 9AN

Other trials in United Kingdom

Belgium1 site

  • Arteveldehogeschool

    Ghent, 9000

Other trials in Belgium

France1 site

  • Centre Hosptalier Douai

    Douai, 59507

Other trials in France

Netherlands1 site

  • Kinetic Analysis

    Breda, 's-Hertogenbosch, 5211 DA

Other trials in Netherlands

About this study

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

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

Read the 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.

Being tested
DWELL (Diabetes and WELLbeing) Programme
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DWELL (Diabetes and WELLbeing) ProgrammeBehavioural

    12-week psychoeducational programme

Study groups in NCT04274660
Study groupRoleWhat they receive
DWELL InterventionExperimentalPeople with type 2 diabetes participating in the 12-week DWELL (Diabetes and WELLbeing) Programme
Receives: Behavioral: DWELL (Diabetes and WELLbeing) Programme
DWELL non-intervention/ControlNo interventionPeople 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, end of programme (3 months), 6 months after programme, 12 months after programme

Secondary outcomes (10)

  1. 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)

    Measured: Baseline, end of programme (3 months), 6 months after programme, 12 months after programme

  2. 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.

    Measured: Baseline, end of programme (3 months), 6 months after programme, 12 months after programme

  3. 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)

    Measured: Baseline, end of programme (3 months), 6 months after programme, 12 months after programme

  4. 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.

    Measured: Baseline, end of programme (3 months), 6 months after programme, 12 months after programme

  5. 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)

    Measured: Baseline, end of programme (3 months), 6 months after programme, 12 months after programme

  6. 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

    Measured: Baseline, end of programme (3 months), 6 months after programme, 12 months after programme

  7. 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

    Measured: Baseline, end of programme (3 months), 6 months after programme, 12 months after programme

  8. 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

    Measured: Baseline, end of programme (3 months), 6 months after programme, 12 months after programme

  9. 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.

    Measured: 2.5 years

  10. 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

    Measured: 2.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2020
  2. Study start8 Sep 2017
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Factorial
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)
Enrolment
594 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04274660
Sponsor's protocol ID
2S01-058 DWELL
Other IDs
10065G00484
Acronym
DWELL
Status last verified
Feb 2023
First submitted
5 Feb 2020
Last updated
14 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

  • 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.

  • 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.

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing DWELL (Diabetes and WELLbeing) Programme in people with Type 2 Diabetes and Type 2 Diabetes Treated With Insulin, run by Canterbury Christ Church University at 5 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United Kingdom, Belgium, France, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04274660, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.

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