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Utilizing Telemedicine for Hypertension Treatment Lifestyle Modification in Central Harlem

Primary Purpose

Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Modification Webinars Focused on Hypertension Control
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension

Eligibility Criteria

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

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.

Sites / Locations

  • Weill Cornell MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Hypertension telemedicine curriculum

Arm Description

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.

Outcomes

Primary Outcome Measures

Participant's Satisfaction with the Curriculum at 12 Weeks
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."
Change in Number of Participants Virtually Attending the Health Education Seminars
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.
Change in Participant's Rate of Completion of Weekly Blood Pressure Recordings
Participant's rate of completion of the weekly blood pressure recording logs will be measured and analyzed.
Change in Participant's Rate of Completion of Weekly Steps Recordings
Participant's rate of completion of the weekly step recording logs will be measured and analyzed.

Secondary Outcome Measures

Mean Change in Systolic Blood Pressure Measurement.
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.
Mean Change in Diastolic Blood Pressure Measurement.
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.
Mean Change in Number of Daily Steps Measured by Pedometer.
Participants will self-report weekly the number of steps taken as measured by their wrist pedometer at baseline through week 12.
Change in Self-Reported Health Attitudes and Behaviors As Assessed by Survey.
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.

Full Information

First Posted
September 2, 2021
Last Updated
November 18, 2022
Sponsor
Weill Medical College of Cornell University
Collaborators
Health Resources and Services Administration (HRSA)
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1. Study Identification

Unique Protocol Identification Number
NCT05062473
Brief Title
Utilizing Telemedicine for Hypertension Treatment Lifestyle Modification in Central Harlem
Official Title
Hypertension Control in the Age of COVID-19: Utilizing Telemedicine for Hypertension Treatment Lifestyle Modification in Central Harlem
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 4, 2021 (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
Weill Medical College of Cornell University
Collaborators
Health Resources and Services Administration (HRSA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypertension telemedicine curriculum
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Modification Webinars Focused on Hypertension Control
Intervention Description
Participation in a 12-week health education telemedicine curriculum
Primary Outcome Measure Information:
Title
Participant's Satisfaction with the Curriculum at 12 Weeks
Description
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."
Time Frame
Week 12
Title
Change in Number of Participants Virtually Attending the Health Education Seminars
Description
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.
Time Frame
Baseline to 12 weeks.
Title
Change in Participant's Rate of Completion of Weekly Blood Pressure Recordings
Description
Participant's rate of completion of the weekly blood pressure recording logs will be measured and analyzed.
Time Frame
Baseline to 12 weeks.
Title
Change in Participant's Rate of Completion of Weekly Steps Recordings
Description
Participant's rate of completion of the weekly step recording logs will be measured and analyzed.
Time Frame
Baseline to 12 weeks.
Secondary Outcome Measure Information:
Title
Mean Change in Systolic Blood Pressure Measurement.
Description
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.
Time Frame
Baseline to week 12
Title
Mean Change in Diastolic Blood Pressure Measurement.
Description
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.
Time Frame
Baseline to week 12
Title
Mean Change in Number of Daily Steps Measured by Pedometer.
Description
Participants will self-report weekly the number of steps taken as measured by their wrist pedometer at baseline through week 12.
Time Frame
Baseline to week 12
Title
Change in Self-Reported Health Attitudes and Behaviors As Assessed by Survey.
Description
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.
Time Frame
Baseline, week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dolores T Reynolds, BSN
Phone
2127464617
Email
dtr2001@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracy K Paul, MD
Organizational Affiliation
Weill Cornell Medicine/NY Presbyterian Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dolores T Reynolds, BSN
Phone
212-746-4617
Email
dtr2001@med.cornell.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11343005
Citation
Artinian NT, Washington OG, Templin TN. Effects of home telemonitoring and community-based monitoring on blood pressure control in urban African Americans: a pilot study. Heart Lung. 2001 May-Jun;30(3):191-9. doi: 10.1067/mhl.2001.112684.
Results Reference
background
PubMed Identifier
29456025
Citation
Liu S, Brooks D, Thomas SG, Eysenbach G, Nolan RP. Effectiveness of User- and Expert-Driven Web-based Hypertension Programs: an RCT. Am J Prev Med. 2018 Apr;54(4):576-583. doi: 10.1016/j.amepre.2018.01.009. Epub 2018 Feb 16.
Results Reference
background
PubMed Identifier
23537980
Citation
Bove AA, Homko CJ, Santamore WP, Kashem M, Kerper M, Elliott DJ. Managing hypertension in urban underserved subjects using telemedicine--a clinical trial. Am Heart J. 2013 Apr;165(4):615-21. doi: 10.1016/j.ahj.2013.01.004. Epub 2013 Mar 6.
Results Reference
background
Links:
URL
https://www1.nyc.gov/assets/doh/downloads/pdf/epi/databrief83.pdf
Description
Hypertension Hospitalizations and Related Morbidity in New York City
URL
https://www1.nyc.gov/assets/doh/downloads/pdf/data/2015chp-mn10.pdf
Description
Community Health Profiles 2015: Central Harlem

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Utilizing Telemedicine for Hypertension Treatment Lifestyle Modification in Central Harlem

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