Clinical trial NCT06147245: The ACCT2 Study Individuals With Type 2 Diabetes and Non-Western Backgrounds (ACCT2)
Official title: A Person-centred and Culturally Sensitive Course of Treatment Targeting Individuals With Type 2 Diabetes and Non-Western Backgrounds (The ACCT2 Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
Glycaemic control
Cultural Sensitivity
Diabetes self-management
Non-Western immigrants
Co-creation
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
First posted: 2023-11-27
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in HbA1c (mmol/mol)
timeFrame: Change from baseline to the end of intervention (12 months)
Secondary outcomes:
measure: Blood lipids (mmol/l)
timeFrame: Change from baseline to the end of intervention (12 months)
measure: Systolic blood pressure (mmHg)
timeFrame: Change from baseline to the end of intervention (12 months)
measure: Diastolic blood pressure (mmHg)
timeFrame: Change from baseline to the end of intervention (12 months)
measure: Resting heart rate (bpm)
timeFrame: Change from baseline to the end of intervention (12 months)
measure: Marker of kidney function - Creatinine (μmmol/L)
timeFrame: Change from baseline to the end of intervention (12 months)
measure: Marker of kidney function - eGFR (mL/min)
timeFrame: Change from baseline to the end of intervention (12 months)
measure: Serum sodium (mmol/L)
timeFrame: Change from baseline to the end of intervention (12 months)
measure: Serum potassium (mmol/L)
timeFrame: Change from baseline to the end of intervention (12 months)
measure: Thyroid-stimulating hormone (TSH) (mIU/L)
timeFrame: Change from baseline to the end of intervention (12 months)
measure: Marker of liver function - Alanine aminotransferase (U/L)
timeFrame: Change from baseline to the end of intervention (12 months)
measure: C-peptide
timeFrame: Change from baseline to the end of intervention (12 months)
measure: Coefficient of variation (CV) of glucose concentrations
timeFrame: Change from baseline to the end of intervention (12 months)
measure: Screening for diabetic nephropathy - Urine albumin (mg)/creatinine (g) ratio
timeFrame: Change from baseline to the end of intervention (12 months)
Other outcomes:
measure: Time-in-range (% 3.9-10.0 mmol/l)
timeFrame: Change from baseline to the end of intervention (12 months)
measure: Time-below-range (% <3.9 mmol/l)
timeFrame: Change from baseline to the end of intervention (12 months)
measure: Time-above-range (% >10.0 mmol/l)
timeFrame: Change from baseline to the end of intervention (12 months)
measure: Body weight (kg)
timeFrame: Change from baseline to the end of intervention (12 months)
measure: Use of antidiabetic medication
timeFrame: Change from baseline to the end of intervention (12 months)
measure: Self-reported well-being
timeFrame: Change from baseline to the end of intervention (12 months)
measure: Self-reported diabetes distress
timeFrame: Change from baseline to the end of intervention (12 months)
measure: Self-reported diabetes management
timeFrame: Change from baseline to the end of intervention (12 months)
measure: Self-reported information regarding social support
timeFrame: Change from baseline to the end of intervention (12 months)
measure: Medicine adherence
timeFrame: Change from baseline to the end of intervention (12 months)
measure: Health literacy
timeFrame: Change from baseline to the end of intervention (12 months)
measure: Degree of participants' participation in intervention activities
timeFrame: There are 6 visits overall and participation will be measured at the end of the intervention (12 months after baseline).
measure: Participants' acceptance of intervention
timeFrame: The interviews will be conducted at the end of intervention (12 months after baseline) at visit 6.
Locations:
city: Herlev
country: Denmark
facility: Steno Diabetes Center Copenhagen
Study officials:
affiliation: Steno Diabetes Center Copenhagen
name: Ulla Bjerre-Christensen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Steno Diabetes Center Copenhagen
name: Natasja B Martinsen, PhD
role: STUDY_DIRECTOR
References: