Skip to main content
OpenTrials
Completed

NCT Number: NCT05424744

Telemedicine Management of Hypertension

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Acceptability of Intervention (AIM)

    Time frame: 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.

  2. Appropriateness of Intervention (IAM)

    Time frame: 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.

  3. Feasibility of Intervention (FIM)

    Time frame: 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).

  4. Fidelity of Intervention/implementation

    Time frame: 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).

  5. Cost Estimates

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Telemedicine Management of Hypertension: A Pre-Implementation Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jun 21, 2022
Registry last updated
Apr 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.