Telemedicine Management of Hypertension

NCT ID: NCT05424744

Last Updated: 2024-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-12

Study Completion Date

2024-04-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

enroll up to 10 patients/clinic
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Telemedicine Management of Hypertension

using home blood pressure monitoring

Group Type EXPERIMENTAL

Telemedicine Management of Hypertension

Intervention Type BEHAVIORAL

Telemedicine Management of high blood pressure using home blood pressure monitoring and telemedicine based hypertension self- management support and pharmacotherapy. This will be supplemented by support from community health workers.

Interventions

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Telemedicine Management of Hypertension

Telemedicine Management of high blood pressure using home blood pressure monitoring and telemedicine based hypertension self- management support and pharmacotherapy. This will be supplemented by support from community health workers.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* \> 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


* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yashashwi Pokharel, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

References

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Manandhar S, Chhetri S, Sutton D, Saha AC, Kaur S, Brown J, Williamson J, Callahan KE, Moore JB, Taylor YJ, Bosworth HB, Pokharel Y. Piloting a team-based telemedicine care for hypertension focused on Black patients. Pilot Feasibility Stud. 2025 Jul 7;11(1):95. doi: 10.1186/s40814-025-01656-y.

Reference Type DERIVED
PMID: 40624567 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB00085682

Identifier Type: -

Identifier Source: org_study_id

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