Telemedicine Management of Hypertension

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Behavioral: Telemedicine Management of Hypertension

• Registration Number: NCT05424744
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-06-09
• Study First Submitted QC: 2022-06-14
• Study First Posted: 2022-06-21
• Study Start: 2023-06-12
• Primary Completion: 2023-10-25
• Status Verified: 2024-04
• Study Completion: 2024-04-01
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Telemedicine Management of Hypertension	Telemedicine Management of Hypertension	using home blood pressure monitoring

Primary Outcome Measures

Name	Time	Method
Acceptability of Intervention (AIM)	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)	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)	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	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	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.

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States