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临床试验/NCT02234973
NCT02234973已完成不适用

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

Lawson Health Research Institute1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
500
试验地点
1
主要终点
mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or older
  • on-reserve residents of participating Indigenous community partners

排除标准

  • 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.

结局指标

主要结局

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

时间窗: repeated measure: 24 months after program start

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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