Novel Model for South Asian Treatment in Diabetes (NaMaSTe-Diabetes) Trial in Primary Care
Namaste
1 other identifier
interventional
600
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes-mellitus
Started Jul 2015
Longer than P75 for not_applicable type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2014
CompletedFirst Posted
Study publicly available on registry
May 13, 2014
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedNovember 27, 2020
November 1, 2020
6.4 years
April 29, 2014
November 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in A1C or blood pressure (systolic or diastolic blood pressure)
within 6 months from baseline; 0, 3, and 6 months
Secondary Outcomes (3)
change in fasting lipid profile
6 months; 0 and 6 months
Change in weight or waist circumference
6 months; 0, 3, and 6 months
change in health status
6 months; 0, 3, and 6 months
Other Outcomes (1)
Procedure related outcomes
6 months; 0, 3, and 6 months
Study Arms (2)
Culturally tailored diabetes program
EXPERIMENTALCulturally tailored diabetes program * culturally tailored diabetes education * lifestyle counselling * medication adherence counseling * peer supporter * communication training * family member involvement
Usual Care
NO INTERVENTIONUsual Care includes continuing to visit primary care physician for ongoing diabetes management Printed diabetes education materials.
Interventions
Includes family member and peer support Includes communication training
Eligibility Criteria
You may qualify if:
- age \>19 years of age
- type 2 diabetes mellitus requiring at least one medication (oral hypoglycemic agent and/or insulin) to control diabetes
- A1C ≥7% in past 1 year
- willingness/ability to attend the Diabetes education, dietician, and peer sessions and follow up assessments
- ability to provide informed consent
- self identify as South Asian (from India, Pakistan, Sri Lanka, or Bangladesh) regardless of generational status or timing of immigration with ability to speak in English or Punjabi.
You may not qualify if:
- life- limiting illness \<12 months
- physical inability to exercise
- recurrent severe hypoglycemia or hypoglycaemic unawareness
- family member of, or living in same household as a participant
- pregnancy or gestational diabetes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of British Columbia
Vancouver, British Columbia, V6Z 1Y6, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nadia A Khan, MD MSc
University of British Columbia
- PRINCIPAL INVESTIGATOR
Tricia Tang, PhD
University pf British Columbia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 29, 2014
First Posted
May 13, 2014
Study Start
July 1, 2015
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
November 27, 2020
Record last verified: 2020-11