Utilizing Telemedicine for Hypertension Treatment Lifestyle Modification in Central Harlem

October 30, 2023 updated by: Weill Medical College of Cornell University

Hypertension Control in the Age of COVID-19: Utilizing Telemedicine for Hypertension Treatment Lifestyle Modification in Central Harlem

The purpose of this study is to test the feasibility of creating a health education telemedicine curriculum that can be delivered by Weill Cornell Medicine faculty and medical students and NY-Presbyterian Hospital resident physicians to community dwelling adults in an under-resourced local community.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female greater than or equal to 18 years of age.
  • Self-report of a hypertension diagnosis.

Exclusion Criteria:

  • Pregnant or breastfeeding.
  • End-stage renal disease on hemodialysis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Hypertension telemedicine curriculum
All participants participate in the 12-week telemedicine curriculum. All participants will be asked to record their steps via pedometer and their blood pressure measurements via automatic blood pressure arm cuff.
Behavioral: Lifestyle Modification Webinars Focused on Hypertension Control
Participation in a 12-week health education telemedicine curriculum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant's Satisfaction with the Curriculum at 12 Weeks
Time Frame: Week 12
Participant's satisfaction with the curriculum will be measured via 5-point Likert scale survey that was created by our research team. Scores will range from a low of "Strongly disagree" to a high of "Strongly agree."
Week 12
Change in Number of Participants Virtually Attending the Health Education Seminars
Time Frame: Baseline to 12 weeks.
Virtual attendance to the health education seminars will be collected. The number of participants who virtually attend all health education seminars over the 12 week period will be collected and change in number of participants attending will be assessed.
Baseline to 12 weeks.
Change in Participant's Rate of Completion of Weekly Blood Pressure Recordings
Time Frame: Baseline to 12 weeks.
Participant's rate of completion of the weekly blood pressure recording logs will be measured and analyzed.
Baseline to 12 weeks.
Change in Participant's Rate of Completion of Weekly Steps Recordings
Time Frame: Baseline to 12 weeks.
Participant's rate of completion of the weekly step recording logs will be measured and analyzed.
Baseline to 12 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in Systolic Blood Pressure Measurement.
Time Frame: Baseline to week 12
Participants will self-report weekly up to 4 blood pressure readings taken at baseline through week 12 with their automatic blood pressure arm cuff. The change in systolic blood pressure measurements in this time frame will be assessed.
Baseline to week 12
Mean Change in Diastolic Blood Pressure Measurement.
Time Frame: Baseline to week 12
Participants will self-report weekly up to 4 blood pressure readings taken at baseline through week 12 with their automatic blood pressure arm cuff. The change in diastolic blood pressure measurements in this time frame will be assessed.
Baseline to week 12
Mean Change in Number of Daily Steps Measured by Pedometer.
Time Frame: Baseline to week 12
Participants will self-report weekly the number of steps taken as measured by their wrist pedometer at baseline through week 12.
Baseline to week 12
Change in Self-Reported Health Attitudes and Behaviors As Assessed by Survey.
Time Frame: Baseline, week 12
The name of the survey is " Knowledge, attitudes, and perceptions towards hypertension and cardiovascular disease." The survey was adapted from the Centers for Disease Control and Prevention Behavioral Risk Factor Surveillance System. It consists of both quantitative and qualitative questions assessing participants' demographics, participants' knowledge and attitudes about diet and exercise, and participants' knowledge about hypertension and other related cardiac diseases (i.e. stroke, coronary artery disease). The survey will be administered at enrollment and post-intervention at week 12. Pre- and post-surveys will be compared for accuracy of answers and change in self-reported behaviors.
Baseline, week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

Health Resources and Services Administration (HRSA)

Investigators

  • Principal Investigator: Tracy K Paul, MD, Weill Cornell Medicine/NY Presbyterian Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2021

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

September 2, 2021

First Submitted That Met QC Criteria

September 20, 2021

First Posted (Actual)

September 30, 2021

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-10022836
  • 1 T1NHP391850100. (Other Grant/Funding Number: Health Resources and Services Administration of the U.S. Department of Health and Human Services)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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