Telemedicine Management of Hypertension: A Pre-Implementation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 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
- 否
入选标准
- •> 18 years of age
- •diagnosis of Hypertension (HTN)
- •systolic Blood Pressure > 140mmHg on last two clinic visits
- •stable anti-HTN medication in the preceding six weeks
- •possess smart phone
- •must speak and read English
排除标准
- •conditions that diminish the ability to conduct home-based self-assessments of Blood Pressure
- •chronic conditions that add complexity in HTN management
- •recent acute health changes that increases likelihood of Blood Pressure instability
- •terminal illness
- •Inclusion Criteria Stakeholders:
- •identify stakeholders using Mendelow's stakeholder matrix, which helps recognize stakeholders according to their interest and power in using the intervention in their clinic - Stakeholders are from clinic and community health workers
研究组 & 干预措施
Telemedicine Management of Hypertension
using home blood pressure monitoring
干预措施: Telemedicine Management of Hypertension (Behavioral)
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