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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Person-centred culturally sensitive course of treatment | Experimental | The intervention consists of a 12-month person-centred and culturally sensitive course of treatment. |
|
| Control | No Intervention | The control group will follow the standard care with regular visits at the T2D outpatient clinic at SDCC 3-4 times/year. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Person-centred culturally sensitive course of treatment | Behavioral | 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. |
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Time-in-range (% 3.9-10.0 mmol/l) | Measured using continous glucose monitoring | Change from baseline to the end of intervention (12 months) |
| Time-below-range (% <3.9 mmol/l) | Measured using continous glucose monitoring |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natasja B Martinsen, PhD | Contact | +45 60157718 | natasja.bjerre.martinsen@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Ulla Bjerre-Christensen, MD | Steno Diabetes Center Copenhagen | Principal Investigator |
| Natasja B Martinsen, PhD | Steno Diabetes Center Copenhagen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center Copenhagen | Recruiting | Herlev | 2730 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40471662 | Derived | 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. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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) |
| Change from baseline to the end of intervention (12 months) |
| Time-above-range (% >10.0 mmol/l) | Measured using continous glucose monitoring | Change from baseline to the end of intervention (12 months) |
| Body weight (kg) | Measured on a digital scale | Change from baseline to the end of intervention (12 months) |
| Use of antidiabetic medication | Change in current use of antidiabetic medication | 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 | 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. | 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'. | 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. | 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. | Change from baseline to the end of intervention (12 months) |
| Health literacy | Assessed from 3 selected items from the Health Literacy Questionnaire (HLQ). | Change from baseline to the end of intervention (12 months) |
| Degree of participants' participation in intervention activities | Assessed from % participation in visits | 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. | The interviews will be conducted at the end of intervention (12 months after baseline) at visit 6. |
| D004700 | Endocrine System Diseases |