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

Steno Diabetes Centers

Status

Enrolling

Conditions

Type 2 Diabetes

Treatments

Behavioral: Person-centred culturally sensitive course of treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT06147245

H-23042245

Details and patient eligibility

About

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.

Full 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:

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).

Enrollment

96 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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