Novel Model for South Asian Treatment in Diabetes (NaMaSTe-Diabetes) Trial in Primary Care (Namaste)

November 24, 2020 updated by: Khan, University of British Columbia
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Recruiting
        • University of British Columbia
        • Contact:
          • Gurpreet Oshan, BA
          • Phone Number: 778 387 3100
        • Contact:
        • Principal Investigator:
          • Nadia Khan, MD
        • Principal Investigator:
          • Tricia Tang, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Culturally tailored diabetes program

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
Includes family member and peer support Includes communication training
No Intervention: Usual Care
Usual Care includes continuing to visit primary care physician for ongoing diabetes management Printed diabetes education materials.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in A1C or blood pressure (systolic or diastolic blood pressure)
Time Frame: within 6 months from baseline; 0, 3, and 6 months
within 6 months from baseline; 0, 3, and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
change in fasting lipid profile
Time Frame: 6 months; 0 and 6 months
6 months; 0 and 6 months
Change in weight or waist circumference
Time Frame: 6 months; 0, 3, and 6 months
6 months; 0, 3, and 6 months
change in health status
Time Frame: 6 months; 0, 3, and 6 months
6 months; 0, 3, and 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure related outcomes
Time Frame: 6 months; 0, 3, and 6 months
health behaviours, medication adherence, patient engagement/activation, diabetes management, diabetes distress, depression, social support, knowledge, motivation, self efficacy.
6 months; 0, 3, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Nadia A Khan, MD MSc, University of British Columbia
  • Principal Investigator: Tricia Tang, PhD, University pf British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

April 29, 2014

First Submitted That Met QC Criteria

May 8, 2014

First Posted (Estimate)

May 13, 2014

Study Record Updates

Last Update Posted (Actual)

November 27, 2020

Last Update Submitted That Met QC Criteria

November 24, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H14-00693

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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