Transformation of Indigenous Primary Healthcare Delivery (FORGE AHEAD)
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|ClinicalTrials.gov Identifier: NCT02234973|
Recruitment Status : Unknown
Verified August 2015 by Dr. Stewart Harris, Lawson Health Research Institute.
Recruitment status was: Recruiting
First Posted : September 9, 2014
Last Update Posted : September 2, 2015
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 or disease|
|Type 2 Diabetes Mellitus|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||434 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||Transformation of Indigenous Primary Healthcare Delivery (FORGE AHEAD): Community-driven Innovations and Strategic Scale-up Toolkits|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||March 2018|
|Indigenous community/clinic team members|
- 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 ]
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
|Contact: Stewart B Harris, MD, MPH||519-661-2111 ext firstname.lastname@example.org|
|Centre for Studies in Family Medicine, Western University||Recruiting|
|London, Ontario, Canada, N6G2M1|
|Contact: Stewart B Harris, MD, MPH 519-661-2111 ext 22050 email@example.com|
|Principal Investigator: Stewart B Harris, MD, MPH|
|Principal Investigator:||Stewart B Harris, MD, MPH||Western University|