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

A Person-centred and Culturally Sensitive Course of Treatment Targeting Individuals With Type 2 Diabetes and Non-Western Backgrounds (The ACCT2 Study)

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Person-centred culturally sensitive course of treatment

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).

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Natasja B Martinsen, PhD; Phone Number: +45 60157718; Email: natasja.bjerre.martinsen@regionh.dk

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Recruiting
    • Steno Diabetes Center Copenhagen
    • Contact: Natasja B Martinsen, Postdoc; Phone Number: +4560157718; Email: natasja.bjerre.martinsen@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Person-centred culturally sensitive course of treatment; The intervention consists of a 12-month person-centred and culturally sensitive course of treatment.	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.
No Intervention: Control; The control group will follow the standard care with regular visits at the T2D outpatient clinic at SDCC 3-4 times/year.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)	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)
Marker of liver function - Alanine aminotransferase (U/L)	Concentration of alanine aminotransferase	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)
Thyroid-stimulating hormone (TSH) (mIU/L)	Level of TSH assessed from blood samples	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)

Other Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Steno Diabetes Center Copenhagen
• Investigators: Principal Investigator: Ulla Bjerre-Christensen, MD, Steno Diabetes Center Copenhagen; Study Director: Natasja B Martinsen, PhD, Steno Diabetes Center Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 19, 2023
• First Submitted That Met QC Criteria: November 19, 2023
• First Posted (Actual): November 27, 2023

Study Record Updates

• Last Update Posted (Estimated): December 2, 2024
• Last Update Submitted That Met QC Criteria: November 28, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Type 2 Diabetes; Glycaemic control; Co-creation; Diabetes self-management; Cultural Sensitivity; Non-Western immigrants
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: H-23042245

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No