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Scaling Telehealth Models to Improve Co-morbid Diabetes and Hypertension (Phase II)

2026年9月28日 更新者：NYU Langone Health

The purpose of this study is to test the effectiveness and implementation process of a culturally and contextually tailored telehealth-based community health worker (CHW) led coaching intervention for hypertension control among South Asian patients with co-morbid Diabetes Mellitus type II (DMII) and hypertension. The primary aims are to test the effectiveness of a CHW-led telehealth intervention compared to usual care, and using Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) and Consolidated Framework for Implementation Research (CFIR), examine the reach, adoption, fidelity, and maintenance of the intervention within clinical and community settings.

研究概览

地位

邀请报名

条件

干预/治疗

研究类型

介入性

注册 (估计的)

450

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。

学习地点

  • 美国
    • Georgia
      • Atlanta、Georgia、美国、30322
        • Emory University
    • New York
      • New York、New York、美国、10016
        • NYU Langone Health

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

21年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • identified as of South Asian ethnicity
  • at least 21 years of age
  • a diagnosis of diabetes
  • a diagnosis of hypertension
  • an uncontrolled BP reading (>130/80mmHg) in the last 6 months

Exclusion Criteria:

  • Under the age of 21
  • Women who are pregnant at the time of screening
  • Type 1 diabetes or diabetes secondary to other conditions (e.g., steroid-induced, pancreatic insufficiency, or chemotherapy-induced)
  • Inability to perform unsupervised physical activity
  • Malignancy or life-threatening illness with life expectancy of <5 years
  • Diagnosed cognitive deficits or limited decision-making capacity

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：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：Community Health Workers (CHW) treatment group

There is a 6-month intervention period immediately following recruitment. Participants enrolled in the intervention will complete 5 educational sessions and attend 2 one-on-one virtual meetings.
行为的：Integrated CHW Intervention

Participants will undergo all 5 group-based health education sessions on hypertension and diabetes management and provide culturally and linguistically tailored health information and resources. There will be two one-on-one virtual meetings, up to 9 follow-up phone calls to engage in goal-setting activities regarding changes to health behaviors, medication adherence, or other issues related to diabetes prevention as identified jointly by patient and CHW. Participants will develop with the CHW and receive a copy of their long-term and short-term Participant Action Plan. Referrals to other services available in the community (i.e. exercise classes, social services, mental health, tobacco cessation, etc.
有源比较器：Control group

The control participants will complete only the first educational session. The control arm will receive usual care from their primary care physician (PCP) during the first 12 months of data collection. After 12 months they will be invited to attend remaining group sessions.
行为的：CHW Session 1 Only

Participants will attend only the first group-based health education session on hypertension and diabetes management.

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
Percent of participants achieving BP control, defined as <130/80 mmHg
大体时间：Month 6

The primary outcome will be the proportion of eligible patients at a practice site to achieve BP control (130/80 mmHg) at six months.
Month 6

次要结果测量

结果测量
措施说明
大体时间
Percent of participants achieving BP control, defined as <130/80 mmHg
大体时间：Month 12

The primary outcome will be the proportion of eligible patients at a practice site to achieve BP control (130/80 mmHg) at twelve months.
Month 12
Change from Baseline in hemoglobin A1c (HbA1c) levels at Month 6
大体时间：Baseline, Month 6

Change in HbA1c will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Baseline, Month 6
Change from Baseline in HbA1c levels at Month 12
大体时间：Baseline, Month 12

Change in HbA1c will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Baseline, Month 12
Change from Baseline in Body mass index (BMI) at Month 6
大体时间：Baseline, Month 6

Change in BMI will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Baseline, Month 6
Change from Baseline in BMI at Month 12
大体时间：Baseline, Month 12

Change in BMI will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Baseline, Month 12
Change from Baseline in Systolic blood pressure (SBP) at Month 6
大体时间：Baseline, Month 6

Change in SBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Baseline, Month 6
Change from Baseline in SBP at Month 12
大体时间：Baseline, Month 12

Change in SBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Baseline, Month 12
Change from Baseline in Diastolic blood pressure (DBP) at Month 6
大体时间：Baseline, Month 6

Change in DBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Baseline, Month 6
Change from Baseline in DBP at Month 12
大体时间：Baseline, Month 12

Change in DBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Baseline, Month 12

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。

赞助

NYU Langone Health

合作者

National Institute on Minority Health and Health Disparities (NIMHD)

调查人员

  • 首席研究员：Nadia Islam, PhD、NYU Langone Health

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 (实际的)

2024年11月11日

初级完成 (估计的)

2028年2月1日

研究完成 (估计的)

2028年2月1日

研究注册日期

首次提交

2024年8月5日

首先提交符合 QC 标准的

2024年8月5日

首次发布 (实际的)

2024年8月7日

研究记录更新

最后更新发布 (实际的)

2026年10月1日

上次提交的符合 QC 标准的更新

2026年9月28日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 19-01192-2
  • 5R01MD018528-02 (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)？

是的

IPD 计划说明

The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: laura.wyatt@nyulangone.org . The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD 共享时间框架

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

IPD 共享访问标准

The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to laura.wyatt@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

IPD 共享支持信息类型

  • 研究方案
  • 树液

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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