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Technology Intervention for High Blood Pressure
N/A
Recruiting
Led By Carolyn Still, PhD
Research Sponsored by Case Western Reserve University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prescribed at least two hypertensive, one of which is a diuretic/thiazide and or calcium channel blocker antihypertensive medication
50 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline - 6 months
Awards & highlights
Study Summary
This trial will test a digital health intervention to improve hypertension control in African American older adults.
Who is the study for?
This trial is for African American individuals over 50 with high blood pressure (BP≥130/80 but <160/90 mmHg), taking at least two BP medications including a diuretic or calcium channel blocker, and who own a smartphone. It's not for those who've had major cardiovascular events in the past year, have cognitive impairments, use other medication apps, show high BP variability, or have severe kidney disease.Check my eligibility
What is being tested?
The OPTIMA-BP trial tests an intervention using mobile health technologies to improve medication adherence and manage high blood pressure among older African Americans. The study aims to see if this tech-based support can help control BP better and reduce health disparities.See study design
What are the potential side effects?
Since the intervention involves technology use rather than medications or invasive procedures, direct side effects are minimal. However, participants may experience challenges related to technology use such as privacy concerns or stress from learning new tools.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am taking two blood pressure medicines, including a water pill or calcium blocker.
Select...
I am 50 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline - 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline - 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Blood Pressure Control
Health Related Quality of Life (HRQOL)
Secondary outcome measures
Biological risk markers
Controlled BP (<130/80 mmHg)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention: OPTIMA-BP ImplementationExperimental Treatment1 Intervention
Participants randomized to OPTIMA-BP intervention for 6 months then observed for a 6 month follow up period
Group II: Waitlist: OPTIMA-BP implementationActive Control1 Intervention
Participants randomized to waitlist for 6 months, then offered the OPTIMA-BP intervention for 6 months.
Find a Location
Who is running the clinical trial?
Case Western Reserve UniversityLead Sponsor
299 Previous Clinical Trials
259,742 Total Patients Enrolled
University Hospitals Cleveland Medical CenterOTHER
317 Previous Clinical Trials
340,049 Total Patients Enrolled
Carolyn Still, PhDPrincipal InvestigatorCase Western Reserve University, School of Nursing
1 Previous Clinical Trials
125 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have chronic kidney disease or am on dialysis.I am able to understand and consent to my treatment.I had a major heart event or surgery in the last year.Your blood pressure goes up and down a lot during different visits.My blood pressure is between 130/80 and 160/90 mmHg.I am taking two blood pressure medicines, including a water pill or calcium blocker.You are currently using a medication tracking app.I am 50 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention: OPTIMA-BP Implementation
- Group 2: Waitlist: OPTIMA-BP implementation
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.
How many people total are allowed to join this experiment?
"The listing on clinicaltrials.gov reveals that this study is currently seeking participants. The trial was first advertised on February 14th, 2021 and has been updated recently on March 15th, 2022. So far, 1 location has recruited 208 patients."
Answered by AI
Are new patients being accepted into this trial at this time?
"The most up-to-date information on clinicaltrials.gov indicates that this study is currently searching for patients to enroll. The trial was first announced on February 14th, 2021 and has undergone one edit since then - taking place on March 15th, 2022."
Answered by AI
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