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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Locations
Denmark
Study Type
Observational
Intervention
Group course
Sponsored by
Steno Diabetes Center Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes self-management, Diabetes Education, Ethnic minorities, Patient empowerment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre for DiabetesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Arm Label

Intervention, Centre for Diabetes or local setting

Usual care

Arm Description

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 in 5 municipalities in the west area of Copenhagen

Outcomes

Primary Outcome Measures

Well-being
questionnaire
diabetes self-management
questionnaire
HbA1c
blood sample

Secondary Outcome Measures

Full Information

First Posted
May 13, 2019
Last Updated
October 20, 2020
Sponsor
Steno Diabetes Center Copenhagen
Collaborators
Center for Diabetes, Copenhagen Municipality
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1. Study Identification

Unique Protocol Identification Number
NCT03950219
Brief Title
CUlturally Sensitive TOols for Ethnic Minorities in Diabetes Self-management Education and Support
Acronym
CUSTOM
Official Title
CUlturally Sensitive TOols and Methods for Ethnic Minorities (CUSTOM): Building Bridges Between Theory and Practice in Diabetes Self-management Education and Support
Study Type
Observational

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Steno Diabetes Center Copenhagen
Collaborators
Center for Diabetes, Copenhagen Municipality

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The CUSTOM research project represents a complex intervention. The project aim of the intervention is, through the delivery of culturally sensitive DSMES, 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. The intervention has been developed in collaboration with the target group and health care professionals from Centre for Diabetes (CfD) in Copenhagen Municipality. CUSTOM will explore feasibility and effectiveness of the intervention including the mechanisms through which outcomes occur and contexts where outcomes are likely to be replicable. The intervention builds on the framework of complex interventions(26), and is designed as an pragmatic randomised controlled trial in three arms. Focus on fidelity, appropriateness and acceptability of the developed intervention. What factors and structures are necessary to facilitate DSMES access and retention among the target group? Which methods and tools supporting diabetes decision making and problem solving are acceptable and feasible among the target group? What educational strategies promote Health Care Professionals' (HCPs') communication with the target group? Focus on exploring effectiveness of the intervention, the mechanisms through which outcomes occur and contexts where outcomes are likely to be replicable. To what extent does the intervention lead to better outcomes (e.g., HbA1c and participant-reported outcomes) than 'usual care' for the target group and what mechanisms for the effect of the intervention can be identified? And are there differences according to the setting, of which the intervention is delivered; a) in a community health centre and b) a local community setting. What characterizes contexts that are most conducive to positive outcomes? What barriers and possibilities exist related to implementing culturally sensitive DSMES in different municipal settings targeting ethnic minority groups? Which contextual factors determine whether the identified mechanisms lead to intended outcomes? What are the long-term effects of the intervention on measured outcomes? Study design CUSTOM is considered a complex intervention due to many interacting components in its design, complex behaviour changes in those delivering and receiving the intervention, many stakeholders, and highly variable outcomes. The trial will be undertaken as a pragmatic trial using cluster randomisation. The trial will be tested in three arms: Participants will be randomised into 3 arms Group A: Centre for Diabetes, Copenhagen Municipality, n = 103 Group B: Local community setting in Tingbjerg, Copenhagen Municipality, n = 103 Group C: Usual care in the west area of Copenhagen, municipalities of Høje-Taastrup, Hvidovre, Albertslund, Brøndby and Ishøj, n = 103 Figure 1 Study Design 9. Interventions 9.1 Group A and B: Group A and B will receive the same interventions but in different contexts - a local community setting and a diabetes care centre. The intervention will be pilot tested in the local community and if necessary adjusted to local contexts. Using a design-based research, the intervention has been developed in collaboration with researchers, the target group and healthcare professionals from Centre for Diabetes (CfD) in Copenhagen Municipality. The group-based course will include 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. The healthcare professionals delivering the education consists of an interdisciplinary team of both a nurse, dietitian, physiotherapist, a translator and a peer educator. The CUSTOM intervention consists of three elements: philosophy/values, educator behaviours and 12 specific dialogue tools. These three elements are all equally important in the organisation and completion of a good and culturally sensitive diabetes education targeting ethnic minorities. The intervention is based on the concept CUSTOM which is developed with regards to the healthcare professionals' approaches, methods and existing educational activities. The concept consists of 12 health education tools accompanied by a comprehensive guide. The success of the tools developed in CUSTOM rely on the values held by the suppliers of the education and by the health care professional's competences to apply the specific dialogue tools.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes self-management, Diabetes Education, Ethnic minorities, Patient empowerment

7. Study Design

Enrollment
309 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention, Centre for Diabetes or local setting
Arm Description
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.
Arm Title
Usual care
Arm Description
Usual care in 5 municipalities in the west area of Copenhagen
Intervention Type
Other
Intervention Name(s)
Group course
Intervention Description
Education and support
Primary Outcome Measure Information:
Title
Well-being
Description
questionnaire
Time Frame
6 months
Title
diabetes self-management
Description
questionnaire
Time Frame
6 months
Title
HbA1c
Description
blood sample
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Study Population Description
Referred to rehabilitation by the GP and has type 2 diabetes
Sampling Method
Probability Sample
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nana F Hempler, PhD
Phone
+45 40732591
Email
nana.folmann.hempler@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Lone B Rasmussen, PhD
Phone
+45 22857377
Email
lone.banke.rasmussen@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nana F Hempler, PhD
Organizational Affiliation
Steno Diabetes Center Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Diabetes
City
Copenhagen
ZIP/Postal Code
1620
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte Glümer, MD, PhD
Email
FS0H@kk.dk
First Name & Middle Initial & Last Name & Degree
Gritt-Marie H Malling
Phone
+45 2910 6797
Email
QI4M@kk.dk

12. IPD Sharing Statement

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

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