CUlturally Sensitive TOols for Ethnic Minorities in Diabetes Self-management Education and Support
CUSTOM
CUlturally Sensitive TOols and Methods for Ethnic Minorities (CUSTOM): Building Bridges Between Theory and Practice in Diabetes Self-management Education and Support
1 other identifier
observational
309
1 country
1
Brief Summary
The CUSTOM research project represents a complex intervention. The project aim of the intervention is, through the delivery of culturally sensitive Diabetes self-management education and support, to support ethnic minorities with type 2 diabetes in making health-promoting decisions about their care and gaining insight into their goals, values and motivation to improve their daily diabetes self-management. The target group comprises ethnic minorities whose native language is Arabic, Urdu or Turkish.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2019
CompletedFirst Submitted
Initial submission to the registry
May 13, 2019
CompletedFirst Posted
Study publicly available on registry
May 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedOctober 22, 2020
October 1, 2020
1.8 years
May 13, 2019
October 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Well-being
questionnaire
6 months
diabetes self-management
questionnaire
6 months
HbA1c
blood sample
6 months
Study Arms (2)
Intervention, Centre for Diabetes or local setting
Group-based course in diabetes education including 6 sessions of approximately 3 hours. Sessions are constructed around themes such as; diabetes knowledge and complication, mental health, diet, physical activity, Ramadan, medicine and include practical exercises such as blood sugar measurements, walking etc.
Usual care
Usual care in 5 municipalities in the west area of Copenhagen
Interventions
Eligibility Criteria
Referred to rehabilitation by the GP and has type 2 diabetes
You may qualify if:
- Clinical diagnosis of type 2 diabetes
- Ability to give written consent
- Ability and willingness to attend and participate in a group-based education programme.
- First language is Arabic, Turkish or Urdu.
You may not qualify if:
- Physical illness that could seriously reduce their life expectancy and ability to participate in the trial
- Mental illness that could reduce their ability to participate in the trial
- Significant alcohol or substance misuse which could limit the participants ability to participate in the trial
- A primary diagnosis of learning disability
- Pregnancy, breastfeeding or plans of pregnancy during the study period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre for Diabetes
Copenhagen, 1620, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nana F Hempler, PhD
Steno Diabetes Center Copenhagen
Central Study Contacts
Study Design
- Study Type
- observational
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Team leader and senior researcher
Study Record Dates
First Submitted
May 13, 2019
First Posted
May 15, 2019
Study Start
March 1, 2019
Primary Completion
December 31, 2020
Study Completion
October 1, 2022
Last Updated
October 22, 2020
Record last verified: 2020-10