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CUlturally Sensitive TOols for Ethnic Minorities in Diabetes Self-management Education and Support (CUSTOM)

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ClinicalTrials.gov Identifier: NCT03950219
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : May 16, 2019
Sponsor:
Collaborator:
Centre for Diabetes, Copenhagen municipality
Information provided by (Responsible Party):
Nana Folmann Hempler, Steno Diabetes Center Copenhagen

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Other: Group course Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 309 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: CUlturally Sensitive TOols and Methods for Ethnic Minorities (CUSTOM): Building Bridges Between Theory and Practice in Diabetes Self-management Education and Support
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : October 2022

Arm Intervention/treatment
Experimental: Intervention, Centre for Diabetes
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.
Other: Group course
Education and support

Experimental: Intervention, 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.
Other: Group course
Education and support

No Intervention: Usual care
Usual care in 5 municipalities in the west area of Copenhagen



Primary Outcome Measures :
  1. Well-being [ Time Frame: 6 months ]
    questionnaire

  2. diabetes self-management [ Time Frame: 6 months ]
    questionnaire

  3. HbA1c [ Time Frame: 6 months ]
    blood sample



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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
  • 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.

Exclusion Criteria:

  • 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

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): NCT03950219


Contacts
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Contact: Nana F Hempler, PhD +45 40732591 nana.folmann.hempler@regionh.dk
Contact: Lone B Rasmussen, PhD +45 22857377 lone.banke.rasmussen@regionh.dk

Locations
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Denmark
Centre for Diabetes Recruiting
Copenhagen, Denmark, 1620
Contact: Charlotte Glümer, MD, PhD       FS0H@kk.dk   
Contact: Gritt-Marie H Malling    +45 2910 6797    QI4M@kk.dk   
Sponsors and Collaborators
Steno Diabetes Center Copenhagen
Centre for Diabetes, Copenhagen municipality
Investigators
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Principal Investigator: Nana F Hempler, PhD Steno Diabetes Center Copenhagen

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Responsible Party: Nana Folmann Hempler, Team leader and senior researcher, Steno Diabetes Center Copenhagen
ClinicalTrials.gov Identifier: NCT03950219     History of Changes
Other Study ID Numbers: CUSTOM
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nana Folmann Hempler, Steno Diabetes Center Copenhagen:
Diabetes self-management
Diabetes Education
Ethnic minorities
Patient empowerment
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases