跳至主要内容
临床试验/NCT06593119
NCT06593119尚未招募不适用

Tailoring a Telemedicine Hypertension Management Intervention for Black Patients

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年10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
尚未招募
入组人数
60
试验地点
2
主要终点
Proportion of patients who are eligible

研究概览

简要总结

Current clinic-based hypertension (HTN) management models have several limitations, resulting in episodic care that does not adequately support patients' self-care skills, and fails to achieve blood pressure (BP) control.

详细描述

Telemedicine management of HTN (TM-HTN) can augment and overcome challenges by allowing more support for patients' HTN self-care skills, providing multiple home Blood Pressure values and overcoming failure to appropriately intensify treatment. TM-HTN consists of 1) home BP monitoring, 2) home BP based pharmacotherapy, and 3) telemedicine-based self-management support.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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
否

入选标准

  • •Subjects must be African American or Black
  • •experiencing socially disadvantage
  • •Patients with systolic Blood Pressure ≥140 mmHg on their last two clinic visits and baseline systolic BP >130 mmHg using the mean of two research BP values measured by trained staff
  • •Subjects must be on stable Blood Pressure medications for the preceding 6 weeks

排除标准

  • •Unable to read or speak English
  • •diminished ability to measure home Blood Pressure
  • •chronic kidney disease ≥stage 4
  • •persistent/chronic atrial fibrillation
  • •severe hypertension >180/110 mmHg
  • •acute health changes in past 3 months increasing chance of Blood Pressure instability
  • •terminal illness

研究组 & 干预措施

Telemedicine management of Hypertension intervention group

Experimental

BP monitor and telehealth application Home BP monitoring Pharmacotherapy Telemedicine-based self-management support Additional support in-person training

干预措施: Telemedicine management of Hypertension (Behavioral)

control group

Placebo Comparator

This includes usual clinic based Hypertension care using routinely available clinic resources (e.g., community health worker, social worker). Clinicians can offer self-management support (e.g., dietician referral) or recommend a home BP monitor. These activities mirror current primary care practice.

干预措施: Usual Care (Behavioral)

结局指标

主要结局

Proportion of patients who are eligible

时间窗: Month 6

Proportion of patients who are eligible

Number of staff needed and time spent for intervention

时间窗: Month 6

staff training, technical support, troubleshooting

Proportion of completed self-measurement of Blood Pressure at home

时间窗: Month 6

Proportion of completed self-measurement of BP at home

Proportion of completed self-management contacts.

时间窗: Month 6

Proportion of completed self-management contacts.

Proportion of patients who are screened

时间窗: Month 6

Proportion of patients who are screened

Proportion of patients who agree to participate

时间窗: Month 6

Proportion of patients who agree to participate

Proportion of patients who decline

时间窗: Month 6

Proportion of patients who decline

次要结局

  • Change in Blood Pressure(Month 6)
  • Medication adherence(Month 6)
  • Feasibility of Intervention Measure [FIM](Month 6)
  • Acceptability of Intervention Measure [AIM](Month 6)
  • Intervention Appropriateness Measure [IAM](Month 6)
  • Patient Assessment of Chronic Illness Care [PACIC](Month 6)
  • Organizational Readiness for Implementing Change [ORIC](Month 6)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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