The ACCT2 Study Individuals With Type 2 Diabetes and Non-Western Backgrounds (ACCT2)

Study Overview
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Brief Summary
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The overall purpose of the present study is to examine the effect of implementing a 12-month person-centred and culturally sensitive intervention on glycaemic control in individuals with type 2 diabetes (T2D) and a non-Western background. We hypothesise that the intervention added to standard care will be superior for reducing HbA1c. Superiority will be claimed if the baseline corrected difference between the two groups is equal to, or surpass, the minimal important difference (5 mmol/mol) in favour of the intervention-group.

Detailed Description
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Individuals with a non-Western background have a higher prevalence of T2D and exhibit poorer glycaemic control (HbA1c levels) than those with Danish ethnic background. Research indicates that individuals with non-Western backgrounds face a number of challenges for effective diabetes management. These challenges include low health literacy, language barriers in accessing and comprehending information, adherence to medication, lifestyle factors, and limited social support. Although studies show that culturally appropriate diabetes education can enhance glycaemic control and improve health behaviours, little is known about effective strategies and methods targeting individuals with non-Western backgrounds and T2D. This suggests a strengthened and systematic effort towards the treatment of individuals with T2D and non-Western backgrounds. 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: To investigate the effect of a 1-year person-centred and culturally sensitive intervention on change in glycaemic control (HbA1c) To describe changes in cardiometabolic risk factors (including blood lipids, markers of glucose metabolism, blood pressure) 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 To describe the extent to which the intervention was conducted as planned (visits, person-centred approach, tools) 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).

Official Title
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A Person-centred and Culturally Sensitive Course of Treatment Targeting Individuals With Type 2 Diabetes and Non-Western Backgrounds (The ACCT2 Study)

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Person-centred culturally sensitive course of treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having T2D with poor glycaemic control (HbA1c ≥53 mmol/mol) and where individual treatment goal for HbA1c has not been achieved (in two consecutive measurements) 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: Age: > 75 years 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Person-centred culturally sensitive course of treatment<br>The intervention consists of a 12-month person-centred and culturally sensitive course of treatment. | Behavioral: Person-centred culturally sensitive course of treatment<br>* 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.<br>|
| No Intervention: Control<br>The control group will follow the standard care with regular visits at the T2D outpatient clinic at SDCC 3-4 times/year. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c (mmol/mol) | Assessed from blood samples in non-fasted state | Change from baseline to the end of intervention (12 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood lipids (mmol/l) | Concentrations of: Total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides | Change from baseline to the end of intervention (12 months) | 
| Systolic blood pressure (mmHg) | Measured in resting state. Blood pressure measurements are repeated three times and mean value is calculated | Change from baseline to the end of intervention (12 months) | 
| Diastolic blood pressure (mmHg) | Measured in resting state. Blood pressure measurements are repeated three times and mean value is calculated | Change from baseline to the end of intervention (12 months) | 
| Resting heart rate (bpm) | Measured in resting state | Change from baseline to the end of intervention (12 months) | 
| Marker of kidney function - Creatinine (μmmol/L) | Concentration of creatinine | Change from baseline to the end of intervention (12 months) | 
| Marker of kidney function - eGFR (mL/min) | Estimated glomerular filtration rate (eGFR) | Change from baseline to the end of intervention (12 months) | 
| Serum sodium (mmol/L) | Serum sodium concentration | Change from baseline to the end of intervention (12 months) | 
| Serum potassium (mmol/L) | Serum potassium concentration | Change from baseline to the end of intervention (12 months) | 
| Thyroid-stimulating hormone (TSH) (mIU/L) | Level of TSH assessed from blood samples | Change from baseline to the end of intervention (12 months) | 
| Marker of liver function - Alanine aminotransferase (U/L) | Concentration of alanine aminotransferase | Change from baseline to the end of intervention (12 months) | 
| C-peptide | Plasma concentration of c-peptide | Change from baseline to the end of intervention (12 months) | 
| Coefficient of variation (CV) of glucose concentrations | Measured using continous glucose monitoring | Change from baseline to the end of intervention (12 months) | 
| Screening for diabetic nephropathy - Urine albumin (mg)/creatinine (g) ratio | Measured in a urine sample | Change from baseline to the end of intervention (12 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes, Glycaemic control, Cultural Sensitivity, Diabetes self-management, Non-Western immigrants, Co-creation