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Trial record 1 of 1 for:    NCT02234973
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Transformation of Indigenous Primary Healthcare Delivery (FORGE AHEAD)

This study is currently recruiting participants.
Verified August 2015 by Dr. Stewart Harris, Lawson Health Research Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT02234973
First Posted: September 9, 2014
Last Update Posted: September 2, 2015
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.
Collaborators:
Canadian Institutes of Health Research (CIHR)
University of Western Ontario, Canada
First Nation Community Partners
Health Canada
First Nations and Inuit Health Branch
Assembly of First Nations
Canadian Diabetes Association
Ontario Stroke Network
Heart and Stroke Foundation of Canada
Toronto Health Economics and Technology Assessment Collaborative
Tri-Ethnic Research Center Colorado State University
Hindsight Healthcare Strategies
AstraZeneca
Information provided by (Responsible Party):
Dr. Stewart Harris, Lawson Health Research Institute
  Purpose

Context: Indigenous peoples experience higher prevalence rates of diabetes and worse health outcomes compared to the general population because of a wide array of factors: social determinants of health, lifestyle, genetic susceptibility, and historic-political and psycho-social factors. Barriers to care that are unique to First Nations communities exacerbate the problem with fragmented healthcare, poor chronic disease management, healthcare staff turnover, and limited, or non-existent, surveillance.

Program: The TransFORmation of IndiGEnous PrimAry HEAlthcare Delivery (FORGE AHEAD) research program aims to develop and evaluate community-driven, culturally relevant, primary healthcare models that enhance chronic disease prevention and management in First Nations communities in Canada. Participants will consist of Indigenous community and clinic team members that will take part in multiple interrelated projects including community profiling, readiness consultations, diabetes registry and surveillance, and quality improvement workshops and action periods.

Design: This mixed-method pre-post observational study will capture: 1) diabetes clinical process and outcomes measures, 2) details about community-driven innovations, and 3) knowledge about the experience and cost of attempting to improve primary delivery in individual Indigenous communities.

Intervention/Instrument: Survey, literature review, 15 month intervention (readiness consultations, implementation and maintenance of a registry and surveillance system, community and clinic focused quality improvement workshops), interviews.

Measures: Primary- mean A1C of patients with diabetes (A1C ≥ 8.0% at baseline); Secondary-clinical process and outcome measures, change in stage of readiness, description of participation and innovation facilitators and barriers.

Policy Implications: The outcomes of this research program have the potential to significantly affect future policy decisions pertaining to chronic disease care in First Nations communities. Policy recommendations will be made to help support Indigenous communities in adopting successful innovations to help address issues related to diabetes and other chronic illnesses. The community-driven innovations developed in FORGE AHEAD and the subsequent policy decisions may enhance chronic disease prevention and management for Indigenous peoples across the country.


Condition
Type 2 Diabetes Mellitus

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Transformation of Indigenous Primary Healthcare Delivery (FORGE AHEAD): Community-driven Innovations and Strategic Scale-up Toolkits

Resource links provided by NLM:


Further study details as provided by Dr. Stewart Harris, Lawson Health Research Institute:

Primary Outcome Measures:
  • mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline) [ Time Frame: repeated measures: baseline (12 months prior to the start of the program) ]
  • mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline) [ Time Frame: repeated measures: 6 month after program start date ]
  • mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline) [ Time Frame: repeated measures: 12 month after program start date ]
  • mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline) [ Time Frame: repeated measure: 18 months after program start ]
  • mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline) [ Time Frame: repeated measure: 24 months after program start ]

Estimated Enrollment: 434
Study Start Date: September 2014
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Indigenous community/clinic team members

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Indigenous community and clinic team members
Criteria

Community members

Inclusion Criteria:

  • 18 years of age or older
  • on-reserve residents of participating Indigenous community partners

Exclusion Criteria:

  • less than 18 years of age
  • off-reserve residents of participating or non-participating Indigenous community partners

Clinic team members

Inclusion Criteria:

  • Health centers of participating Indigenous community partners
  • Current type 2 diabetes mellitus registry and surveillance system

Exclusion Criteria:

  • Health centers of non-participating Indigenous community partners
  • No registry or surveillance system

Diabetes Registry

Inclusion Criteria:

  • adults (age≥ 18 years) with type 2 diabetes and most recent HbA1C≥ 8.0%

Exclusion Criteria:

  • gestational diabetes, type 1 diabetes, or severe co-morbidity associated with life expectancy <6 months.
  Contacts and Locations
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): NCT02234973


Contacts
Contact: Stewart B Harris, MD, MPH 519-661-2111 ext 22050 stewart.harris@schulich.uwo.ca

Locations
Canada, Ontario
Centre for Studies in Family Medicine, Western University Recruiting
London, Ontario, Canada, N6G2M1
Contact: Stewart B Harris, MD, MPH    519-661-2111 ext 22050    stewart.harris@schulich.uwo.ca   
Principal Investigator: Stewart B Harris, MD, MPH         
Sponsors and Collaborators
Lawson Health Research Institute
Canadian Institutes of Health Research (CIHR)
University of Western Ontario, Canada
First Nation Community Partners
Health Canada
First Nations and Inuit Health Branch
Assembly of First Nations
Canadian Diabetes Association
Ontario Stroke Network
Heart and Stroke Foundation of Canada
Toronto Health Economics and Technology Assessment Collaborative
Tri-Ethnic Research Center Colorado State University
Hindsight Healthcare Strategies
AstraZeneca
Investigators
Principal Investigator: Stewart B Harris, MD, MPH Western University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Stewart Harris, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02234973     History of Changes
Other Study ID Numbers: 0000031372
First Submitted: July 30, 2014
First Posted: September 9, 2014
Last Update Posted: September 2, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases