跳至主要内容
临床试验/NCT05424744
NCT05424744已完成不适用

Telemedicine Management of Hypertension: A Pre-Implementation Study

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年6月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Acceptability of Intervention (AIM)

研究概览

简要总结

Explore barriers, facilitators, acceptability, feasibility, and fidelity of the telemedicine management of hypertension intervention

详细描述

The purpose of the current study is to conduct pre-implementation work to understand the determinants of the telemedicine management of hypertension intervention implementation, feasibility of the intervention and its tailoring, and explore potential inequitable implementation factors in African American patients to enhance the intervention's usability to inform future hybrid trial design.

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Acceptability of Intervention (AIM)

时间窗: Month 3

Acceptability will be assessed using mixed methods from both patients and stakeholders. The study team will derive themes from relevant constructs about implementation acceptability using qualitative interviews. The study team will complement this using a quantitative measure, Acceptability of Intervention Measure (AIM), which is a validated four item generic implementation outcome measures to assess implementation acceptability. Embedded mixed methods will allow alignment in results of the qualitative and quantitative analyses to provide context, complementarity, and convergence.

Appropriateness of Intervention (IAM)

时间窗: Month 3

Appropriateness will be assessed using mixed methods from both patients and stakeholders. The study team will derive themes from relevant constructs about implementation appropriateness using qualitative interviews. The study team will complement this using a quantitative measure, Intervention Appropriateness Measure (IAM), which is a validated four item generic implementation outcome measures to assess implementation appropriateness. Embedded mixed methods will allow alignment in results of the qualitative and quantitative analyses to provide context, complementarity, and convergence.

Feasibility of Intervention (FIM)

时间窗: Month 3

Feasibility will be assessed using mixed methods from both patients and stakeholders. The study team will derive themes from relevant constructs about implementation feasibility using qualitative interviews. The study team will complement this using a quantitative measure, Feasibility Intervention Measure (FIM), which is a validated four item generic implementation outcome measures to assess implementation feasibility. Embedded mixed methods will allow alignment in results of the qualitative and quantitative analyses to provide context, complementarity, and convergence. As an additional feasibility outcome, the study team will assess the proportion of eligible and screened patients who agree to participate as well as those who decline (with reasons).

Fidelity of Intervention/implementation

时间窗: Month 3

The study team will assess implementation fidelity both at the provider level (number of contacts between patients and nurses; number of pharmacologic activations) and at the patient level (number of home blood pressure data transferred).

Cost Estimates

时间窗: Month 3

The study team will estimate cost by calculating the numbers of clinic staff needed and the time spent (by provider type) per patient as well as other resources required for implementation. The study team will document resource commitment (e.g., staff time by provider type \[nurses, advanced practice providers, physicians, community health workers\], equipment, support \[investigative team's support for device set-up, technical and implementation help\]) for cost assessments. The study team will stratify cost related to the intervention and implementation strategy.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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