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Mobile Health Coaching for High Blood Pressure
N/A
Waitlist Available
Led By Amber Johnson, MD
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 1 or more antihypertensive medications
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
Study Summary
This trial will test an intervention to help adults with uncontrolled hypertension better manage their condition. Results will inform future research.
Who is the study for?
This trial is for adults over 18 with high blood pressure that isn't controlled, even though they're on medication. Participants must speak English and live in a disadvantaged neighborhood. It's not for those who can't understand the study, are institutionalized, have had malignant hypertension or serious sensory or brain function issues.Check my eligibility
What is being tested?
The study is testing a new way to manage high blood pressure using mobile health coaching compared to enhanced usual care. The goal is to see if this approach works well and if people like it before moving on to a larger test.See study design
What are the potential side effects?
Since this trial focuses on mHealth coaching intervention rather than medications, direct side effects aren't expected as with drug trials. However, participants may experience stress or anxiety from self-management responsibilities.
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 ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Participant acceptance and adherence to program
Participant satisfaction and usability
Practicality of participant self-monitoring behavior
Secondary outcome measures
Blood pressure change
Blood pressure control
Locus of control
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Behavioral mHealth Coaching InterventionExperimental Treatment1 Intervention
Those randomized to the intervention group will receive a smartphone with the intervention program preloaded in addition to a BP monitor. After recruitment, participants will receive a confirmatory interview, informed consent, and baseline device training via telephone, delivered by an experienced research assistant. Participants will be encouraged to complete 1 morning BP reading daily, irrespective of study arm, however, only the intervention group will receive reminders from the mHealth coaching intervention to check BP daily. BP readings are automatically uploaded via Bluetooth to a centralized, secure platform to be accessible to the study PI.
Group II: Enhanced Usual CareActive Control1 Intervention
The active comparison group will receive a smartphone with the WebMD® health information application preloaded and a BP monitor. After recruitment, participants will receive a confirmatory interview, informed consent, and baseline device training via telephone, delivered by an experienced research assistant. Participants will be encouraged to complete 1 morning BP reading daily, irrespective of study arm. BP readings are automatically uploaded via Bluetooth to a centralized, secure platform to be accessible to the study PI.
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Who is running the clinical trial?
University of PittsburghLead Sponsor
1,719 Previous Clinical Trials
16,342,301 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,835 Previous Clinical Trials
47,310,630 Total Patients Enrolled
Amber Johnson, MDPrincipal InvestigatorUniversity of Pittsburgh
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You live in a neighborhood that faces challenges or difficulties.I have had severe high blood pressure that caused organ damage.I have major issues with feeling or thinking clearly.I am taking medication for high blood pressure.
Research Study Groups:
This trial has the following groups:- Group 1: Enhanced Usual Care
- Group 2: Behavioral mHealth Coaching Intervention
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.
What are the chief aims of this clinical experiment?
"This 90 day trial's main objective is to measure participant satisfaction and assess usability. Secondary objectives include gauging resilience through the Connor-Davidson Scale, tracking medication adherence with Voil's adherence scale, as well as evaluating blood pressure change (measured in mmHg) from baseline to day 90 of the experiment."
Answered by AI
Are there still openings in this research project?
"This medical trial is not searching for participants, as per the most recent update on clinicaltrials.gov from May 3rd 2023. There are however multiple other trials currently enrolling patients - 759 to be exact - that potential applicants could explore instead."
Answered by AI
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