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Transformation of Indigenous Primary Healthcare Delivery (FORGE AHEAD)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02234973
Recruitment Status : Active, not recruiting
First Posted : September 9, 2014
Last Update Posted : August 9, 2018
Sponsor:
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):
Stewart Harris, Lawson Health Research Institute

Tracking Information
First Submitted Date July 30, 2014
First Posted Date September 9, 2014
Last Update Posted Date August 9, 2018
Actual Study Start Date September 2014
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 8, 2014)
  • 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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Transformation of Indigenous Primary Healthcare Delivery
Official Title Transformation of Indigenous Primary Healthcare Delivery (FORGE AHEAD): Community-driven Innovations and Strategic Scale-up Toolkits
Brief 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.

Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 3 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Indigenous community and clinic team members
Condition 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.
Study Groups/Cohorts 11 First Nations Community and Clinical Teams
11 Community & Clinical Teams in each First Nation community participated in the intervention.
Intervention: Behavioral: Quality Improvement
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: August 7, 2018)
500
Original Estimated Enrollment
 (submitted: September 8, 2014)
434
Estimated Study Completion Date June 30, 2019
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT02234973
Other Study ID Numbers 0000031372
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Stewart Harris, Lawson Health Research Institute
Study Sponsor Lawson Health Research Institute
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
Investigators
Principal Investigator: Stewart B Harris, MD, MPH Western University
PRS Account Lawson Health Research Institute
Verification Date August 2018