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OpenTrials
Completed

NCT Number: NCT02234973

Transformation of Indigenous Primary Healthcare Delivery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre for Studies in Family Medicine, Western University

London, Ontario, N6G2M1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quality improvement

Behavioral

Community and Clinical Teams engaged in implementing Quality Improvement initiatives to improve diabetes prevention and management within their First Nations community and clinic.

Primary outcomes

  1. 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)

  2. mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)

    Time frame: repeated measures: 6 month after program start date

  3. mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)

    Time frame: repeated measures: 12 month after program start date

  4. mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)

    Time frame: repeated measure: 18 months after program start

  5. mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)

    Time frame: repeated measure: 24 months after program start

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Collaborators

  • Assembly of First Nations
  • AstraZeneca
  • Canadian Diabetes Association
  • Canadian Institutes of Health Research (CIHR)
  • First Nation Community Partners
  • First Nations and Inuit Health Branch
  • Health Canada
  • Heart and Stroke Foundation of Canada
  • Hindsight Healthcare Strategies
  • Ontario Stroke Network
  • Toronto Health Economics and Technology Assessment Collaborative
  • Tri-Ethnic Research Center Colorado State University
  • University of Western Ontario, Canada

Registry information

Official study title

Transformation of Indigenous Primary Healthcare Delivery (FORGE AHEAD): Community-driven Innovations and Strategic Scale-up Toolkits

Acronym: FORGE AHEAD

Important dates

Study start
2014
Primary completion
2017
Study completion
2020
First posted
Sep 9, 2014
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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