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Telemedicine Management of Hypertension

Primary Purpose

Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telemedicine Management of Hypertension
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypertension focused on measuring hypertension management, blood pressure monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Patients:

  • > 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

Exclusion Criteria Patients:

  • 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

Sites / Locations

  • Wake Forest University Health SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Telemedicine Management of Hypertension

Arm Description

using home blood pressure monitoring

Outcomes

Primary Outcome Measures

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.
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.
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).
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).
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.

Secondary Outcome Measures

Full Information

First Posted
June 9, 2022
Last Updated
July 28, 2023
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05424744
Brief Title
Telemedicine Management of Hypertension
Official Title
Telemedicine Management of Hypertension: A Pre-Implementation Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 12, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
hypertension management, blood pressure monitoring

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
enroll up to 10 patients/clinic
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telemedicine Management of Hypertension
Arm Type
Experimental
Arm Description
using home blood pressure monitoring
Intervention Type
Behavioral
Intervention Name(s)
Telemedicine Management of Hypertension
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability of Intervention (AIM)
Description
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.
Time Frame
Month 3
Title
Appropriateness of Intervention (IAM)
Description
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.
Time Frame
Month 3
Title
Feasibility of Intervention (FIM)
Description
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).
Time Frame
Month 3
Title
Fidelity of Intervention/implementation
Description
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).
Time Frame
Month 3
Title
Cost Estimates
Description
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.
Time Frame
Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients: > 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 Exclusion Criteria Patients: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa McCorkle, BA
Phone
336-422-1259
Email
lmccorkl@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yashashwi Pokharel, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa McCorkle, BA
Phone
336-422-1259
Email
lmccorkl@wakehealth.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Telemedicine Management of Hypertension

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