The ACCT2 Study Individuals With Type 2 Diabetes and Non-Western Backgrounds (ACCT2)
NCT ID: NCT06147245
Last Updated: 2024-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
96 participants
INTERVENTIONAL
2023-11-09
2025-12-31
Brief Summary
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Detailed Description
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Overall, the ACCT2 study consists of three phases; 1) Need assessment, 2) Intervention development and testing, and 3) Randomized controlled trial (RCT). The aim of the present study (RCT) is to examine the effectiveness of a 12-month person-centred and culturally sensitive intervention on glycaemic control in individuals with T2D and a non-Western background (speaking either Urdu, Arabic or Turkish as native language). Participants will attend 6 visits at Steno Diabetes Center Copenhagen (SDCC): Visit 1 (baseline), visit 2 (two weeks after baseline), visit 3 (4 weeks after baseline), visit 4 (4 months after baseline), visit 5 (7-8 months after baseline), visit 6 (12 months after baseline).
The specific objectives are:
1. To investigate the effect of a 1-year person-centred and culturally sensitive intervention on change in glycaemic control (HbA1c)
2. To describe changes in cardiometabolic risk factors (including blood lipids, markers of glucose metabolism, blood pressure)
3. To describe changes in patient-reported outcomes including overall health, well-being, quality of life, social support, diabetes management, diabetes distress, health behaviour, health literacy, medicine adherence, time-below-range (TBR), time-above-range (TAB), time-in-range (TIR), body weight and use of antidiabetic medicine
4. To describe the extent to which the intervention was conducted as planned (visits, person-centred approach, tools)
5. To explore participants' experiences with following the intervention and acceptance of it, including how a person-centred and culturally sensitive approach worked for them as well as the use of using technology for diabetes monitoring (sub-population).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Person-centred culturally sensitive course of treatment
The intervention consists of a 12-month person-centred and culturally sensitive course of treatment.
Person-centred culturally sensitive course of treatment
12-month person-centred and culturally sensitive intervention: Participants will attend 6 visits at SDCC including visits with a diabetes nurse, physician and dietitian. The course of treatment is focusing on extended time in consultations, use of technology for diabetes monitoring, meeting the same healthcare professionals, awareness of language barriers and use of accurate communication and dialogue tools in participants native language.
Control
The control group will follow the standard care with regular visits at the T2D outpatient clinic at SDCC 3-4 times/year.
No interventions assigned to this group
Interventions
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Person-centred culturally sensitive course of treatment
12-month person-centred and culturally sensitive intervention: Participants will attend 6 visits at SDCC including visits with a diabetes nurse, physician and dietitian. The course of treatment is focusing on extended time in consultations, use of technology for diabetes monitoring, meeting the same healthcare professionals, awareness of language barriers and use of accurate communication and dialogue tools in participants native language.
Eligibility Criteria
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Inclusion Criteria
* Having a non-Western background speaking either Urdu, Arabic or Turkish as native language
* Already in a course of treatment at the outpatient T2D clinic at SDCC
Exclusion Criteria
* Residing part-time in Denmark
* Marker of kidney function - estimated glomerular filtration rate (eGFR) below 30 mL/min
* Having severe mental disorders
* Having disabilities inhibiting physical attendance
* Participant's general condition contraindicates continuing the study, as judged by the investigator or a medical expert
* Participant's withdrawal of the informed consent
18 Years
75 Years
ALL
No
Sponsors
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Steno Diabetes Center Copenhagen
OTHER
Responsible Party
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Principal Investigators
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Ulla Bjerre-Christensen, MD
Role: PRINCIPAL_INVESTIGATOR
Steno Diabetes Center Copenhagen
Natasja B Martinsen, PhD
Role: STUDY_DIRECTOR
Steno Diabetes Center Copenhagen
Locations
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Steno Diabetes Center Copenhagen
Herlev, , Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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Bjerre N, Christensen L, Hoeiberg C, Ottosson C, Jensen MK, Kildsig N, Moller TK, Termannsen AD, Ewers B, Hollender-Schou B, Grue RM, Bjerre-Christensen U, Jansen S, Akram K. Effectiveness of a Person-Centered and Culturally Sensitive Course of Treatment in Arabic-, Turkish-, and Urdu-Speaking Individuals With Type 2 Diabetes (the ACCT2 Study): Protocol for a Pragmatic Randomized Controlled Trial. JMIR Res Protoc. 2025 Jun 5;14:e67319. doi: 10.2196/67319.
Other Identifiers
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H-23042245
Identifier Type: -
Identifier Source: org_study_id