Telemedicine Management of Hypertension

NCT05424744 | Completed DMC

• 1 other identifier: IRB00085682
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension

Keywords

hypertension management; blood pressure monitoring

Outcome Measures

Primary Outcomes (5)

• Acceptability of Intervention (AIM)

  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.

  Month 3

• Appropriateness of Intervention (IAM)

  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.

  Month 3

• Feasibility of Intervention (FIM)

  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).

  Month 3

• Fidelity of Intervention/implementation

  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).

  Month 3

• Cost Estimates

  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.

  Month 3

Study Arms (1)

Telemedicine Management of Hypertension

EXPERIMENTAL

using home blood pressure monitoring

Behavioral: Telemedicine Management of Hypertension

Interventions

Telemedicine Management of Hypertension 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.

Telemedicine Management of Hypertension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

• 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.

  PMID: 40624567 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yashashwi Pokharel, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: enroll up to 10 patients/clinic

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 21, 2022
• Study Start: June 12, 2023
• Primary Completion: October 25, 2023
• Study Completion: April 1, 2024
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)