An interventional study of Culturally tailored diabetes program in Type 2 Diabetes Mellitus, sponsored by University of British Columbia. Status unknown at 1 site in Canada. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2020-11-27.
Sponsored by University of British Columbia · Not applicable, Interventional, and Health services research
South Asians (SA) living in Canada and globally have high rates of type 2 diabetes (diabetes). Despite the burden of diabetes in this population, diabetes management remains poor. SA patients are less likely to exercise, follow a healthy diet (4), participate in exercise programs (5), and are 24% less likely to achieve glucose, blood pressure and lipid targets for diabetes than the general population (6). 55-60% of SA patients were non-adherent to their diabetes life-saving medications, compared to 30-35% non-adherence in the general population (7). This large gap in diabetes care is not surprising given language and communication barriers between primary care providers and SA patients (8-10), lack of knowledge about diabetes (8-11), preference for alternative therapies (12-14) and fundamentally different cultural beliefs on diabetes and diabetes management (15-18). Although there is some preliminary evidence that culturally tailored, chronic disease models may improve outcomes (21-24), the current evidence base is insufficient to justify the system modifications required to provide culturally tailored care across primary care settings in Canada. We propose to conduct a randomized controlled trial to assess the impact of a novel culturally tailored lifestyle and medication adherence intervention in SA patients with poorly controlled diabetes. The study is called the Novel Model for South Asian diabetes Treatment (NaMaSTe-Diabetes) trial in primary care.
South Asians living in Canada and globally have high rates of chronic diseases including hypertension, type 2 diabetes (diabetes) and cardiac disease (1-3). Diabetes is arguably one of the most pressing chronic diseases among South Asian (SA) populations as it occurs at 50% higher rates in SA patients than the general population, develops 5-10 years earlier, and is one of the principal causes of premature heart attack and death in this group (1). Despite the burden of diabetes in this population, diabetes management remains poor. Under the current health care system, SA patients are less likely to exercise, follow a healthy diet (4), participate in exercise programs (5), and are 24% less likely to achieve glucose, blood pressure and lipid targets for diabetes than the general population (6). 55-60% of SA patients were non-adherent to their diabetes life-saving medications, compared to 30-35% non-adherence in the general population (7). This large gap in diabetes care is not surprising given language and communication barriers between primary care providers and SA patients (8-10), lack of knowledge about diabetes (8-11), preference for alternative therapies (12-14) and fundamentally different cultural beliefs on diabetes and diabetes management (15-18). Although there is some preliminary evidence that culturally tailored, chronic disease models may improve outcomes (21-24), the current evidence base is insufficient to justify the system modifications required to provide culturally tailored care across primary care settings in Canada. We propose to conduct a randomized controlled trial to assess the impact of a novel culturally tailored lifestyle and medication adherence intervention in SA patients with poorly controlled diabetes. The study is called the Novel Model for South Asian diabetes Treatment (NaMaSTe-Diabetes) trial in primary care. The study aims to recruit 600 patients with type 2 diabetes and randomize them to either a culturally tailored lifestyle and medication adherence intervention (family based, culturally tailored diabetes self management education with ongoing peer support) versus usual care on glycemic control (change in A1C level) and change in blood pressure (systolic and diastolic blood pressure) from baseline to 6 months in SA patients with poorly controlled type 2 diabetes. The NaMaSTe trial is a multi-center individual randomized controlled trial of 600 SA patients with poorly controlled diabetes (A1C ≥7%) living in British Columbia, Canada.
10,926 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 600 is above the median of 80 across 8,368 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of British Columbia is the lead sponsor of 1,310 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Culturally tailored diabetes program * culturally tailored diabetes education * lifestyle counselling * medication adherence counseling * peer supporter * communication training * family member involvement
Behavioral: Culturally tailored diabetes program
Usual Care includes continuing to visit primary care physician for ongoing diabetes management Printed diabetes education materials.
Includes family member and peer support Includes communication training
Change in A1C or blood pressure (systolic or diastolic blood pressure)
Time frame: within 6 months from baseline; 0, 3, and 6 months
change in fasting lipid profile
Time frame: 6 months; 0 and 6 months
Change in weight or waist circumference
Time frame: 6 months; 0, 3, and 6 months
change in health status
Time frame: 6 months; 0, 3, and 6 months
Procedure related outcomes
health behaviours, medication adherence, patient engagement/activation, diabetes management, diabetes distress, depression, social support, knowledge, motivation, self efficacy.
Time frame: 6 months; 0, 3, and 6 months
This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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University of British Columbia