Feasibility of Home Telehealth Monitoring for Improvement in Management of Hypertension for Secondary Stroke Prevention

Sponsor

Johns Hopkins University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03517709

Collaborator

(none)

Enrollment

Location

Arms

28.7

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This research is being done to determine how home blood pressure monitoring, using a commercially available blood pressure monitor with the capability of transmitting readings to stroke doctors can help manage blood pressure in the optimal range after a stroke. High blood pressure is the leading risk factor for stroke. It is important to control high blood pressure after a stroke to prevent another one from happening. We will use the Withings Smart Blood Pressure Monitor for daily blood pressure measurements.

Tracking of blood pressure measurements will be done via iPod Touch equipped with internet connectivity. We hope to learn if this method of managing blood pressure is more effective than the standard way of having patients visit primary care physicians (the control group for this study). We will also get feedback from participants who will receive the Withings Smart Blood Pressure Monitor about the ease of use and overall satisfaction with this blood pressure device. People 18-100 years old who have had a stroke in the past 6 months may join. You will be excluded from the study if you are pregnant or plan on becoming pregnant in the near future.

Condition or Disease	Intervention/Treatment	Phase
Stroke Hypertension	Other: Primary Care Physician Management of blood pressure Device: Withings Smart Blood Pressure Monitor	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Feasibility of Home Telehealth Monitoring for Improvement in Management of Hypertension for Secondary Stroke Prevention

Actual Study Start Date :

Dec 20, 2016

Actual Primary Completion Date :

May 13, 2019

Actual Study Completion Date :

May 13, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Conventional	Other: Primary Care Physician Management of blood pressure You will receive a 30-minute education session about your blood pressure medications and the need to take them every day. Your primary care physician will make recommendations on your optimal target blood pressure range and medication recommendations. .
Other: Blood Pressure Monitor	Device: Withings Smart Blood Pressure Monitor We will use the Withings Smart Blood Pressure Monitor for daily blood pressure measurements.

Arm

Intervention/Treatment

Other: Conventional

Other: Primary Care Physician Management of blood pressure

You will receive a 30-minute education session about your blood pressure medications and the need to take them every day. Your primary care physician will make recommendations on your optimal target blood pressure range and medication recommendations. .

Other: Blood Pressure Monitor

Device: Withings Smart Blood Pressure Monitor

We will use the Withings Smart Blood Pressure Monitor for daily blood pressure measurements.

Outcome Measures

Primary Outcome Measures

Blood pressure [3 months]
The blood pressure will be obtained on Day 90 by measuring three consecutive times and obtaining an average.
Stroke in 90 days [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

People 18-100 years old who have had a stroke in the past 6 months may join.

Exclusion Criteria:

You will be excluded from the study if you are pregnant or plan on becoming pregnant in the near future.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

Johns Hopkins University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT03517709

Other Study ID Numbers:

IRB00119776

First Posted:

May 7, 2018

Last Update Posted:

May 15, 2019

Last Verified:

May 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Additional relevant MeSH terms:

Stroke

Hypertension

Study Results

No Results Posted as of May 15, 2019