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

NCT ID: NCT02136654

Last Updated: 2020-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus

Keywords

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diabetes ethnicity South Asian diabetes management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Culturally tailored diabetes program

Culturally tailored diabetes program

* culturally tailored diabetes education
* lifestyle counselling
* medication adherence counseling
* peer supporter
* communication training
* family member involvement

Group Type EXPERIMENTAL

Culturally tailored diabetes program

Intervention Type BEHAVIORAL

Includes family member and peer support Includes communication training

Usual Care

Usual Care includes continuing to visit primary care physician for ongoing diabetes management Printed diabetes education materials.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Culturally tailored diabetes program

Includes family member and peer support Includes communication training

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Khan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nadia A Khan, MD MSc

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Tricia Tang, PhD

Role: PRINCIPAL_INVESTIGATOR

University pf British Columbia

Locations

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University of British Columbia

Vancouver, British Columbia, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Gurpreet Oshan, BA

Role: CONTACT

Phone: 778 387 3100

Email: [email protected]

Nadia A Khan, MD MSc

Role: CONTACT

Phone: 604 682 2344

Email: [email protected]

Facility Contacts

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Gurpreet Oshan, BA

Role: primary

Nadia Khan, MD

Role: backup

Other Identifiers

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H14-00693

Identifier Type: -

Identifier Source: org_study_id