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A Pilot Study to Improve Diabetes Management Through Family-Based Health Care Navigation (HOOKELE)

2026年7月15日 更新者:Kaiser Permanente
The purpose of this research study is to compare the impact of providing culturally-tailored, diabetes management education in a group setting to standard diabetes care. We are conducting this study because previous research has demonstrated culturally tailored care can be effective in addressing health disparities. However, it has not been offered in a group setting, among Native Hawaiians and Pacific Islanders who share similar social experiences.

研究概览

详细说明

The purpose of this small R01 is to test the feasibility and preliminary efficacy of a family-based DSMES and social care navigation intervention to improve diabetes-related outcomes among NHPI patients with poorly managed diabetes and social needs. KP Hawaii NHPI patients (N = 80) age ≥ 18, recent A1C >8%, and who report >1 social needs will be recruited and randomized to one of two study arms: 1) family-based group centered DSMES and social care navigation intervention; or 2) enhanced usual care. In the family-based intervention, participants and their family members will receive the 6-week NHPI culturally adapted DSMES program that will be delivered by a NHPI pharmacist from the Mauliola Pharmacy. In collaboration with our partners, Hui No Ke Ola Pono, a community-based organization that employs CHWs, enrolled participants and their family members will be assigned a NHPI CHW who will provide navigation support to social services and community-based resources to address social needs for 6 months. Participants in the enhanced usual care arm will receive standard diabetes clinical care and be provided with a tailored community-based resource list. Feasibility will be determined using mixed methods and based on recruitment, retention, attendance, social need resolution, and several implementation outcomes. We will also examine intervention preliminary effects on diabetes distress, self-management, self-efficacy/empowerment, A1C, and healthcare utilization at 6 months. We propose the following aims:

Aim 1. Determine feasibility of the family-based group centered DSMES and social care navigation intervention based on: a) recruitment and retention rates; b) session attendance; c) number of participants with social need(s) met, not met, or pending at 6 months; d) acceptability; e) practicality; f) fidelity; and g) cultural appropriateness.

Aim 2. Explore preliminary efficacy by comparing the two study arms on the following outcomes at 6-months post-randomization: a) diabetes distress; b) diabetes self-management; c) diabetes self-efficacy; d) mean change in A1C; e) proportion of participants with a clinic-based A1C test; and f) proportion of patients who attended a scheduled follow-up primary care appointment.

研究类型

介入性

注册 (估计的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. age 18 or older;
  2. identify as Native Hawaiian or Pacific Islander;
  3. diagnosed with type 2 diabetes;
  4. most recent A1C ≥ 8%;
  5. reports ≥ 1 social need;
  6. receive care at KPHI, and
  7. have an adult family member who will commit to attending classes with the participant.

Exclusion Criteria: Patients who are not able to provide informed consent due to cognitive impairment

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Family-based group-centered DSMES plus social care navigation intervention
In the family-based group-centered intervention, participants and their family member (who may be food preparers or meal planners such as spouses, parents, or adult children) will participate in an existing 6-week, NHPI culturally adapted DSMES program offered by a NHPI community partner. Each participant and family unit will be assigned a NHPI CHW who will provide navigation support to social services and community-based resources to address social needs for 6 months.
In the family-based group-centered intervention, participants and their family member (who may be food preparers or meal planners such as spouses, parents, or adult children) will participate in an existing 6-week, NHPI culturally adapted DSMES program offered by a NHPI community partner. Each participant and family unit will be assigned a NHPI CHW who will provide navigation support to social services and community-based resources to address social needs for 6 months.
有源比较器:Enhanced routine care
Participants in the enhanced routine care arm will receive the standard diabetes clinical care at KP Hawaii and be provided with a tailored community-based resource list.
Participants in the enhanced routine care arm will receive the standard diabetes clinical care at KP Hawaii and be provided with a tailored community-based resource list.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Feasibility of the family-based DSMES and social care intervention
大体时间:6-months follow-up

Fidelity

  1. DSMES session attendance of the patient (Goal 75% of sessions attended)
  2. DSMES session attendance of the family support (Goal 75% of sessions attended)
  3. CHW visits scheduled and attended
6-months follow-up
Feasibility of the family-based DSMES and social care intervention
大体时间:6-months follow-up

Fidelity

  • DSMES session attendance of the patient (Goal 75% of sessions attended)
  • DSMES session attendance of the family support (Goal 75% of sessions attended)
  • CHW visits scheduled and attended
6-months follow-up

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

合作者

调查人员

  • 首席研究员:Maile Taualii, PhD, MPH、Kaiser Permanente

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月15日

初级完成 (估计的)

2027年8月31日

研究完成 (估计的)

2028年8月31日

研究注册日期

首次提交

2026年7月13日

首先提交符合 QC 标准的

2026年7月13日

首次发布 (实际的)

2026年7月16日

研究记录更新

最后更新发布 (实际的)

2026年7月17日

上次提交的符合 QC 标准的更新

2026年7月15日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • R01DK142020 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Confidential Patient Information

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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