An interventional study of Person-centred culturally sensitive course of treatment in Type 2 Diabetes, sponsored by Steno Diabetes Center Copenhagen. Status unknown at 1 site in Denmark. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-12-02.
Sponsored by Steno Diabetes Center Copenhagen · Not applicable, Interventional, and Treatment
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:
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This study's planned enrollment of 96 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
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Exclusion Criteria:
The intervention consists of a 12-month person-centred and culturally sensitive course of treatment.
Behavioral: Person-centred culturally sensitive course of treatment
The control group will follow the standard care with regular visits at the T2D outpatient clinic at SDCC 3-4 times/year.
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.
Change 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)
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)
Time-in-range (% 3.9-10.0 mmol/l)
Measured using continous glucose monitoring
Time frame: Change from baseline to the end of intervention (12 months)
Time-below-range (% <3.9 mmol/l)
Measured using continous glucose monitoring
Time frame: Change from baseline to the end of intervention (12 months)
Time-above-range (% >10.0 mmol/l)
Measured using continous glucose monitoring
Time frame: Change from baseline to the end of intervention (12 months)
Body weight (kg)
Measured on a digital scale
Time frame: Change from baseline to the end of intervention (12 months)
Use of antidiabetic medication
Change in current use of antidiabetic medication
Time frame: Change from baseline to the end of intervention (12 months)
Self-reported well-being
Assessed from the WHO-5 well-being index.The WHO-5 consists of five statements, which respondents rate from 0 to 5 (in relation to the past two weeks).The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being
Time frame: Change from baseline to the end of intervention (12 months)
Self-reported diabetes distress
Assessed from the Problem Areas in Diabetes Scale (PAID-5 scale) comprising five of the emotional-distress questions of the full PAID items. Each item can be rated from 0 to 4. A total score of ≥ 8 indicates possible diabetes related emotional distress.
Time frame: Change from baseline to the end of intervention (12 months)
Self-reported diabetes management
Assessed from 9 selected items on diabetes management from The Danish National Patient Reported Outcome Questionnaire (Danish PRO scheme (diabetes), item 27-35). The items can be rated from 'very sure/confident' to 'not sure/confident at all'.
Time frame: Change from baseline to the end of intervention (12 months)
Self-reported information regarding social support
Assessed from item 70 of social support questionnaire (the Danish National Health Survey, item 70). The question refers to contact with other people.
Time frame: Change from baseline to the end of intervention (12 months)
Medicine adherence
Assessed from the MARS-5. The questions can be rated from 1 to 5. The MARS-5 score is calculated by summing the numeric score (range 1-5) from each question. A higher score indicates better adherence.
Time frame: Change from baseline to the end of intervention (12 months)
Health literacy
Assessed from 3 selected items from the Health Literacy Questionnaire (HLQ).
Time frame: Change from baseline to the end of intervention (12 months)
Degree of participants' participation in intervention activities
Assessed from % participation in visits
Time frame: There are 6 visits overall and participation will be measured at the end of the intervention (12 months after baseline).
Participants' acceptance of intervention
Assessed by individual interviews on participants' acceptance of intervention in terms of experiences and how intervention activities were supportive. This refers only to the intervention group. Individual interviews will be conducted by a qualitative researcher with a sub-group of participants in the intervention group after the last visit.
Time frame: The interviews will be conducted at the end of intervention (12 months after baseline) at visit 6.
This study is status unknown, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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