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.
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: 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).
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.
Steno Diabetes Center Copenhagen
Herlev, Denmark
RECRUITINGChange in HbA1c (mmol/mol)
Assessed from blood samples in non-fasted state
Time frame: Change from baseline to the end of intervention (12 months)
Blood lipids (mmol/l)
Concentrations of: Total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides
Time frame: 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
Time frame: 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
Time frame: Change from baseline to the end of intervention (12 months)
Resting heart rate (bpm)
Measured in resting state
Time frame: Change from baseline to the end of intervention (12 months)
Marker of kidney function - Creatinine (μmmol/L)
Concentration of creatinine
Time frame: Change from baseline to the end of intervention (12 months)
Marker of kidney function - eGFR (mL/min)
Estimated glomerular filtration rate (eGFR)
Time frame: Change from baseline to the end of intervention (12 months)
Serum sodium (mmol/L)
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
Serum sodium concentration
Time frame: Change from baseline to the end of intervention (12 months)
Serum potassium (mmol/L)
Serum potassium concentration
Time frame: Change from baseline to the end of intervention (12 months)
Thyroid-stimulating hormone (TSH) (mIU/L)
Level of TSH assessed from blood samples
Time frame: Change from baseline to the end of intervention (12 months)
Marker of liver function - Alanine aminotransferase (U/L)
Concentration of alanine aminotransferase
Time frame: Change from baseline to the end of intervention (12 months)
C-peptide
Plasma concentration of c-peptide
Time frame: Change from baseline to the end of intervention (12 months)
Coefficient of variation (CV) of glucose concentrations
Measured using continous glucose monitoring
Time frame: 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
Time frame: Change from baseline to the end of intervention (12 months)