Back to resultsFeasibility of Home Telehealth Monitoring for Improvement in Management of Hypertension for Secondary Stroke Prevention
Primary Purpose
Stroke, Hypertension
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Primary Care Physician Management of blood pressure
Withings Smart Blood Pressure Monitor
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
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.
Sites / Locations
- Johns Hopkins Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Conventional
Blood Pressure Monitor
Arm Description
Outcomes
Primary Outcome Measures
Blood pressure
The blood pressure will be obtained on Day 90 by measuring three consecutive times and obtaining an average.
Stroke in 90 days
Secondary Outcome Measures
Full Information
NCT ID
NCT03517709
First Posted
December 18, 2017
Last Updated
May 13, 2019
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT03517709
Brief Title
Feasibility of Home Telehealth Monitoring for Improvement in Management of Hypertension for Secondary Stroke Prevention
Official Title
Feasibility of Home Telehealth Monitoring for Improvement in Management of Hypertension for Secondary Stroke Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Withdrawn
Why Stopped
No recruitment of subjects
Study Start Date
December 20, 2016 (Actual)
Primary Completion Date
May 13, 2019 (Actual)
Study Completion Date
May 13, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional
Arm Type
Other
Arm Title
Blood Pressure Monitor
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Primary Care Physician Management of blood pressure
Intervention Description
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. .
Intervention Type
Device
Intervention Name(s)
Withings Smart Blood Pressure Monitor
Intervention Description
We will use the Withings Smart Blood Pressure Monitor for daily blood pressure measurements.
Primary Outcome Measure Information:
Title
Blood pressure
Description
The blood pressure will be obtained on Day 90 by measuring three consecutive times and obtaining an average.
Time Frame
3 months
Title
Stroke in 90 days
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Feasibility of Home Telehealth Monitoring for Improvement in Management of Hypertension for Secondary Stroke Prevention
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