NCT04274660

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
594

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
4 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 8, 2017

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 18, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2023

Enrollment Period

5.3 years

First QC Date

February 5, 2020

Last Update Submit

February 13, 2024

Conditions

Type 2 DiabetesType 2 Diabetes Treated With Insulin

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (10)

  • Change in quality of life as assessed by the Short Form Health Survey (SF-12)

    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)

    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)

    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)

    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)

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

  • +5 more secondary outcomes

Study Arms (2)

DWELL Intervention

EXPERIMENTAL

People with type 2 diabetes participating in the 12-week DWELL (Diabetes and WELLbeing) Programme

Behavioral: DWELL (Diabetes and WELLbeing) Programme

DWELL non-intervention/Control

NO INTERVENTION

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

Interventions

DWELL (Diabetes and WELLbeing) ProgrammeBEHAVIORAL

12-week psychoeducational programme

DWELL Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Arteveldehogeschool

Ghent, 9000, Belgium

Location

Centre Hosptalier Douai

Douai, 59507, France

Location

Kinetic Analysis

Breda, 's-Hertogenbosch, 5211 DA, Netherlands

Location

Medway Community Healthcare

Gillingham, Kent, ME8 0PZ, United Kingdom

Location

Blackthorn Trust

Maidstone, Kent, ME16 9AN, United Kingdom

Location

Related Publications (4)

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Health

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

  • Eleni Hatzidimitriadou, PhD

    Canterbury Christ Church University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2020

First Posted

February 18, 2020

Study Start

September 8, 2017

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

February 14, 2024

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, 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 March 2023.
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.

Locations

NL(1)FR(1)BE(1)GB(2)