Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02136654 |
| Other study ID # |
H14-00693 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2015 |
| Est. completion date |
December 2021 |
Study information
| Verified date |
November 2020 |
| Source |
University of British Columbia |
| Contact |
Gurpreet Oshan, BA |
| Phone |
778 387 3100 |
| Email |
gurpreetoshan[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
