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

Type 2 Diabetes Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06147245
• Other study ID #: H-23042245
• Status: Recruiting
• Phase: N/A
• Start date: October 9, 2023
• Est. completion date: June 7, 2025

Study information

• Verified date: November 2023
• Source: Steno Diabetes Center Copenhagen
• Contact: Natasja B Martinsen, PhD
• Phone: +45 60157718
• Email: natasja.bjerre.martinsen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: June 7, 2025
• Est. primary completion date: June 7, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• Person-centred culturally sensitive course of treatment
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.

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center Copenhagen	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Steno Diabetes Center Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time-in-range (% 3.9-10.0 mmol/l)	Measured using continous glucose monitoring	Change from baseline to the end of intervention (12 months)
Other	Time-below-range (% <3.9 mmol/l)	Measured using continous glucose monitoring	Change from baseline to the end of intervention (12 months)
Other	Time-above-range (% >10.0 mmol/l)	Measured using continous glucose monitoring	Change from baseline to the end of intervention (12 months)
Other	Body weight (kg)	Measured on a digital scale	Change from baseline to the end of intervention (12 months)
Other	Use of antidiabetic medication	Change in current use of antidiabetic medication	Change from baseline to the end of intervention (12 months)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	Health literacy	Assessed from 3 selected items from the Health Literacy Questionnaire (HLQ).	Change from baseline to the end of intervention (12 months)
Other	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).
Other	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.
Primary	Change in HbA1c (mmol/mol)	Assessed from blood samples in non-fasted state	Change from baseline to the end of intervention (12 months)
Secondary	Blood lipids (mmol/l)	Concentrations of: Total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides	Change from baseline to the end of intervention (12 months)
Secondary	Systolic 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)
Secondary	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)
Secondary	Resting heart rate (bpm)	Measured in resting state	Change from baseline to the end of intervention (12 months)
Secondary	Marker of kidney function - Creatinine (µmmol/L)	Concentration of creatinine	Change from baseline to the end of intervention (12 months)
Secondary	Marker of kidney function - eGFR (mL/min)	Estimated glomerular filtration rate (eGFR)	Change from baseline to the end of intervention (12 months)
Secondary	Serum sodium (mmol/L)	Serum sodium concentration	Change from baseline to the end of intervention (12 months)
Secondary	Serum potassium (mmol/L)	Serum potassium concentration	Change from baseline to the end of intervention (12 months)
Secondary	Thyroid-stimulating hormone (TSH) (mIU/L)	Level of TSH assessed from blood samples	Change from baseline to the end of intervention (12 months)
Secondary	Marker of liver function - Alanine aminotransferase (U/L)	Concentration of alanine aminotransferase	Change from baseline to the end of intervention (12 months)
Secondary	C-peptide	Plasma concentration of c-peptide	Change from baseline to the end of intervention (12 months)
Secondary	Coefficient of variation (CV) of glucose concentrations	Measured using continous glucose monitoring	Change from baseline to the end of intervention (12 months)
Secondary	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)