Transformation of Indigenous Primary Healthcare Delivery

Type 2 Diabetes Mellitus Clinical Trial

— FORGE AHEAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02234973
• Other study ID #: 0000031372
• Status: Completed
• Start date: September 2014
• Est. completion date: March 31, 2020

Study information

• Verified date: February 2020
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: March 31, 2020
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

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.

Locations

Country	Name	City	State
Canada	Centre for Studies in Family Medicine, Western University	London	Ontario

Sponsors (14)

Lead Sponsor

Collaborator

Lawson Health Research Institute

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

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean HbA1C of patients with diabetes (A1C = 8.0% at baseline)		repeated measures: baseline (12 months prior to the start of the program)
Primary	mean HbA1C of patients with diabetes (A1C = 8.0% at baseline)		repeated measures: 6 month after program start date
Primary	mean HbA1C of patients with diabetes (A1C = 8.0% at baseline)		repeated measures: 12 month after program start date
Primary	mean HbA1C of patients with diabetes (A1C = 8.0% at baseline)		repeated measure: 18 months after program start
Primary	mean HbA1C of patients with diabetes (A1C = 8.0% at baseline)		repeated measure: 24 months after program start

External Links

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