Utilizing Telemedicine for Hypertension Treatment Lifestyle Modification in Central Harlem

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05062473
• Other study ID #: 20-10022836
• Secondary ID: 1 T1NHP391850100
• Status: Withdrawn
• Phase: N/A
• Start date: October 4, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: October 2023
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• Lifestyle Modification Webinars Focused on Hypertension Control
Participation in a 12-week health education telemedicine curriculum

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Health Resources and Services Administration (HRSA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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."	Week 12
Primary	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.	Baseline to 12 weeks.
Primary	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.	Baseline to 12 weeks.
Primary	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.	Baseline to 12 weeks.
Secondary	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.	Baseline to week 12
Secondary	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.	Baseline to week 12
Secondary	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.	Baseline to week 12
Secondary	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.	Baseline, week 12

External Links

•   Community Health Profiles 2015: Central Harlem
•   Hypertension Hospitalizations and Related Morbidity in New York City