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临床试验/NCT01235429
NCT01235429已完成不适用

Specific Aim 3: Partners in Care Randomized Controlled Trial

University of Hawaii2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2009年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
hemoglobin A1c

研究概览

简要总结

Type 2 diabetes is common among Native Hawaiians and Pacific Peoples. Diabetes related complications decrease quality of life and can result in early morbidity. The purpose of the Partners in Care diabetes self-management educational intervention is to teach participants how to manage their diabetes to avoid or delay diabetes-related complications and how to better work with their health care team.

详细描述

This is a feasibility study using a randomized controlled trial (RCT) design in which 100 Native Hawaiians (NHs) and other Pacific Islanders (PPs) will be randomized to either a 3-month diabetes self-management group (DSMG; N=50) or a delayed intervention control group (CG; N=50). Participants in the DSMG will receive culturally-tailored, group diabetes self-management education delivered in a community setting by trained community peer educators. To meet this objective, we have partnered with four community-based organizations: 1) Hawai'i Maoli Association of Hawaiian Civic Clubs, 2) Ke Ola Mamo Native Hawaiian Health Care System, 3) Kokua Kalihi Valley Comprehensive Family Services, and 4) Kula No Nā Po'e Hawai'i. These four organizations provide services to a large number of Pacific People to include, but not limited to, Native Hawaiians, Samoans, Filipinos, and Chuukese. They already have intervention research experience as members of the PILI 'Ohana CBPR Project. The 3-month face-to-face intervention will be community-based and community-led by trained community peer educators from these four partnering community organizations. Individuals with a hemoglobin A1c (HbA1c; average blood sugar levels) >=8% will be recruited for the study because they represent the most at-risk for diabetes-related complications.

Over a 1-year accrual period, the community partners will recruit and enroll 100 eligible NHs and PPs (25 participants per a participating community), 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
Randomized
干预模型
Crossover
主要目的
Prevention
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

  • Self-reported Native Hawaiian, Filipino, or other Pacific Islander ethnic background,
  • Adults age >=18 years,
  • English-speaking,
  • Physician-diagnosed type 2 diabetes, and
  • Baseline hemoglobin A1c >=8%

排除标准

  • Survival less than 6 months,
  • Planning to move off island or out of state during the 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).

结局指标

主要结局

hemoglobin A1c

时间窗: 3 months

Hemoglobin A1c will be assessed at baseline and post intervention in the intervention and delayed intervention participants.

次要结局

  • Quality of life(3 months)

研究者

发起方
University of Hawaii
申办方类型
Other

研究点 (2)

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