NCT05062473

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 30, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

October 4, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

1.4 years

First QC Date

September 2, 2021

Last Update Submit

October 30, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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.

  • 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.

  • 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 Outcomes (4)

  • Mean Change in Systolic Blood Pressure Measurement.

    Baseline to week 12

  • Mean Change in Diastolic Blood Pressure Measurement.

    Baseline to week 12

  • Mean Change in Number of Daily Steps Measured by Pedometer.

    Baseline to week 12

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

    Baseline, week 12

Study Arms (1)

Hypertension telemedicine curriculum

OTHER

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

Interventions

Participation in a 12-week health education telemedicine curriculum

Hypertension telemedicine curriculum

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10021, United States

Location

Related 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.

    PMID: 11343005BACKGROUND
  • 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.

    PMID: 29456025BACKGROUND
  • 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.

    PMID: 23537980BACKGROUND

Related Links

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Tracy K Paul, MD

    Weill Cornell Medicine/NY Presbyterian Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2021

First Posted

September 30, 2021

Study Start

October 4, 2021

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

November 1, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations