NCT03517709

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.

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 Dec 2016

Typical duration for not_applicable stroke

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withdrawn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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 7, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2019

Completed
Last Updated

May 15, 2019

Status Verified

May 1, 2019

Enrollment Period

2.4 years

First QC Date

December 18, 2017

Last Update Submit

May 13, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Blood pressure

    The blood pressure will be obtained on Day 90 by measuring three consecutive times and obtaining an average.

    3 months

  • Stroke in 90 days

    3 months

Study Arms (2)

Conventional

OTHER
Other: Primary Care Physician Management of blood pressure

Blood Pressure Monitor

OTHER
Device: Withings Smart Blood Pressure Monitor

Interventions

* 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. .

Conventional

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

Blood Pressure Monitor

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

StrokeHypertension

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2017

First Posted

May 7, 2018

Study Start

December 20, 2016

Primary Completion

May 13, 2019

Study Completion

May 13, 2019

Last Updated

May 15, 2019

Record last verified: 2019-05

Locations