Utilizing Telemedicine for Hypertension Treatment Lifestyle Modification in Central Harlem

Sponsor
Weill Medical College of Cornell University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05062473
Collaborator
(none)
40
1
1
11.9
3.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Lifestyle Modification Webinars Focused on Hypertension Control
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Hypertension Control in the Age of COVID-19: Utilizing Telemedicine for Hypertension Treatment Lifestyle Modification in Central Harlem
Actual Study Start Date :
Oct 4, 2021
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Participant's Satisfaction with the Curriculum at 12 Weeks [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."

  2. Change in Number of Participants Virtually Attending the Health Education Seminars [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.

  3. Change in Participant's Rate of Completion of Weekly Blood Pressure Recordings [Baseline to 12 weeks.]

    Participant's rate of completion of the weekly blood pressure recording logs will be measured and analyzed.

  4. Change in Participant's Rate of Completion of Weekly Steps Recordings [Baseline to 12 weeks.]

    Participant's rate of completion of the weekly step recording logs will be measured and analyzed.

Secondary Outcome Measures

  1. Mean Change in Systolic Blood Pressure Measurement. [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.

  2. Mean Change in Diastolic Blood Pressure Measurement. [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.

  3. Mean Change in Number of Daily Steps Measured by Pedometer. [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.

  4. Change in Self-Reported Health Attitudes and Behaviors As Assessed by Survey. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Weill Cornell Medicine New York New York United States 10021

Sponsors and Collaborators

  • Weill Medical College of Cornell University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT05062473
Other Study ID Numbers:
  • 20-10022836
  • 1 T1NHP391850100.
First Posted:
Sep 30, 2021
Last Update Posted:
Feb 28, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 28, 2022