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Mobile Health Program for High Blood Pressure
N/A
Recruiting
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prescribed use of one or more antihypertensive agents as identified by the International Society of Hypertension core drug-treatment strategy
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 months
Awards & highlights
Study Summary
This trial will test a home-based blood pressure monitoring program with health education and coaching to see if it can help reduce cardiovascular disease in rural populations.
Who is the study for?
This trial is for rural residents with uncontrolled high blood pressure who are on hypertension medication and can use a smartphone. They must speak English well enough for the study, not be pregnant or planning pregnancy soon, and not have severe health issues like recent heart failure or life-threatening conditions.Check my eligibility
What is being tested?
The study tests a home-based blood pressure monitoring program against regular monitoring plus WebMD app usage. It aims to see if personalized coaching and education help manage hypertension better in rural areas.See study design
What are the potential side effects?
Since this trial involves non-drug interventions like using an app and monitoring devices, side effects may include discomfort from frequent blood pressure checking or stress from self-management of health data.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am taking medication for high blood pressure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in systolic and diastolic blood pressure from baseline to 6 months
Secondary outcome measures
Adherence to antihypertensive medications
Patient-Reported Outcomes
Pharmaceutical Preparations
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment2 Interventions
A smartphone-based, interactive coaching application designed to enhance adherence to home-based blood pressure monitoring, provided guidance on blood pressure management, patient-facing education, and assistance with modifying behaviors associated with poor blood pressure control; connected to a wireless blood pressure cuff for accurate blood pressure measurement and automated storage on a digital platform. All participants in the experimental arm receive a smartphone for the 6-month intervention duration and the home-based blood pressure cuff.
Group II: Enhanced usual careActive Control2 Interventions
WebMD, a smartphone-based tool for learning about blood pressure and other health conditions. Enhanced usual care participants receive a wireless blood pressure cuff for accurate blood pressure measurement and automated storage on a digital platform. All participants in the experimental arm receive a smartphone for the 6-month intervention duration and the home-based blood pressure cuff.
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Who is running the clinical trial?
University of PittsburghLead Sponsor
1,719 Previous Clinical Trials
16,342,007 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,834 Previous Clinical Trials
47,310,301 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for a major surgery soon.I was hospitalized for heart failure within the last 3 months.You live in one of the 48 counties considered rural by the Center for Rural Pennsylvania.I understand the study's requirements and passed the consent quiz.I have not had a heart attack or severe chest pain in the last 3 months.I have high blood pressure that's not well-controlled, with specific readings on two visits.I do not have a non-heart related condition expected to be fatal within a year.I have had very high blood pressure (over 200/120 mm Hg).I am taking medication for high blood pressure.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Enhanced usual care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment for this investigation still open?
"This medical study, which was first publicized on June 1st 2023, is not presently recruiting. The most recent update to the clinicaltrials.gov listing was made on September 19th 2022. While this particular trial doesn't require further participants at present there are 1060 other trials actively accepting new enrollees."
Answered by AI
What is the ultimate goal of this clinical investigation?
"The primary assessment tool for this trial is Change in blood pressure from baseline to 6 months. Secondary metrics include Patient-Reported Outcomes, Adherence to antihypertensive medications using Proportion of Days Covered, and Self-efficacy for managing medications and treatment scored on a 10-item instrument ranging from 10 (minimum) to 40 (maximum)."
Answered by AI
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