An observational study in Type 2 Diabetes Mellitus, sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-11.
Sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's · Observational
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 500 is above the median of 300 across 1,588 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's is the lead sponsor of 352 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Indigenous community and clinic team members
Community members
Inclusion Criteria:
Exclusion Criteria:
Clinic team members
Inclusion Criteria:
Exclusion Criteria:
Diabetes Registry
Inclusion Criteria:
Exclusion Criteria:
11 Community \& Clinical Teams in each First Nation community participated in the intervention.
Behavioral: Quality Improvement
Community and Clinical Teams engaged in implementing Quality Improvement initiatives to improve diabetes prevention and management within their First Nations community and clinic.
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
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's