Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02136654
Recruitment Status : Recruiting
First Posted : May 13, 2014
Last Update Posted : November 27, 2020
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Khan, University of British Columbia

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Behavioral: Culturally tailored diabetes program Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Novel Model for South Asian Treatment in Diabetes (NaMaSTe-Diabetes) Trial in Primary Care
Study Start Date : July 2015
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in A1C or blood pressure (systolic or diastolic blood pressure) [ Time Frame: within 6 months from baseline; 0, 3, and 6 months ]

Secondary Outcome Measures :
  1. change in fasting lipid profile [ Time Frame: 6 months; 0 and 6 months ]
  2. Change in weight or waist circumference [ Time Frame: 6 months; 0, 3, and 6 months ]
  3. change in health status [ Time Frame: 6 months; 0, 3, and 6 months ]

Other Outcome Measures:
  1. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02136654


Contacts
Layout table for location contacts
Contact: Gurpreet Oshan, BA 778 387 3100 gurpreetoshan@gmail.com
Contact: Nadia A Khan, MD MSc 604 682 2344 ext 63657 nakhanubc@gmail.com

Locations
Layout table for location information
Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Gurpreet Oshan, BA    778 387 3100      
Contact: Nadia Khan, MD       nakhanubc@gmail.com   
Principal Investigator: Nadia Khan, MD         
Principal Investigator: Tricia Tang, PhD         
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Investigators
Layout table for investigator information
Principal Investigator: Nadia A Khan, MD MSc University of British Columbia
Principal Investigator: Tricia Tang, PhD University pf British Columbia
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Khan, Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT02136654    
Other Study ID Numbers: H14-00693
First Posted: May 13, 2014    Key Record Dates
Last Update Posted: November 27, 2020
Last Verified: November 2020
Keywords provided by Khan, University of British Columbia:
diabetes
ethnicity
South Asian
diabetes management
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases