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临床试验/NCT02320344
NCT02320344已完成不适用

Partnerships to Improve Lifestyle Interventions (PILI) 'Ohana Dissemination Project Partners in Care

University of Hawaii2 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2013年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
47
试验地点
2
主要终点
Hemoglobin A1c

研究概览

简要总结

The 3-month face-to-face Partners in Care intervention will be community-based and community-led by trained community peer educators from these four partnering community organizations. The intervention involves 12 weekly, group lessons with each lesson lasting about 1 and 1/2 hours. Individuals with a hemoglobin A1c (HbA1c; average blood sugar levels) greater than or equal to 7% will be recruited for the study because they represent the most at-risk for diabetes-related complications. Over a 3-year accrual period, the community partners will recruit and enroll 150 eligible NHs and PPs, as well as deliver and evaluate the intervention in their respective community settings. The primary outcomes of our study are hemoglobin A1c and self-reported diabetes specific quality of life. Secondary outcomes are cholesterol levels (including HDL, LDL, total cholesterol, and triglycerides), blood pressure, body mass index, and psychosocial adaptation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

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

  • Adults age >18 years of age,
  • English-speaking,
  • Physician-diagnosed type 2 diabetes, and
  • Baseline hemoglobin A1c >7%.

排除标准

  • Survival less than 6 months,
  • Planning to move out of the community during the intervention study period,
  • Any co-morbid condition (physical and mental disabilities) that would prevent the individual from participating in the intervention protocol (i.e., major psychiatric illness).

研究组 & 干预措施

Partners in Care

Experimental

干预措施: Partners in Care (Behavioral)

结局指标

主要结局

Hemoglobin A1c

时间窗: 3 months

change in hemoglobin A1c from baseline to 3-months

Problem Areas in Diabetes

时间窗: 3 months

The Problem Areas in Diabetes (PAID) will be used to assess diabetes specific quality of life. Change in PAID score from baseline to 3-months

次要结局

  • Total Cholesterol (including HDL and LDL)(3 months)
  • Triglycerides(3 months)

研究者

发起方
University of Hawaii
申办方类型
Other
责任方
Principal Investigator
主要研究者

Joseph Keawe'aimoku Kaholokula

Professor and Chair

University of Hawaii

研究点 (2)

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