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Technology-Enabled Team Care for High Blood Pressure
N/A
Waitlist Available
Led By Doyle Cummings, Pharm.D.
Research Sponsored by East Carolina University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 months follow-up
Awards & highlights
Study Summary
This trial aims to compare a new model of care that uses cellular-enabled home BP monitoring combined with team-based care to an enhanced usual care group to improve BP control and address social challenges in people with hypertension.
Who is the study for?
This trial is for adults over 18 with a history of uncontrolled high blood pressure, particularly Hispanic and non-Hispanic black (majority) and white individuals. Participants must have had an average systolic BP of at least 140 mmHg in the past year and speak English without needing an interpreter. Those with severe kidney disease, dementia, substance abuse issues, or pregnant women are excluded.Check my eligibility
What is being tested?
The study compares two approaches to managing high blood pressure: one uses technology-enabled home monitoring plus team care including pharmacist support for medication management and lifestyle advice; the other provides just the monitor with basic instructions. The main goal is to see which method better controls systolic blood pressure.See study design
What are the potential side effects?
There may not be direct side effects from participating in this trial as it involves monitoring and management rather than testing new medications. However, changes in medication by pharmacists could lead to typical drug-related side effects such as dizziness or fatigue.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 and 12 months follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 months follow-up
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 Blood Pressure (SBP) level at 6 months follow-up
Secondary outcome measures
Change in Systolic Blood Pressure (SBP) level at 12 months follow-up
Improved SBP Control at 6 and 12 months
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Technology enabled Team CareExperimental Treatment1 Intervention
Ongoing Team-based, Pharmacist led telephonic management of uncontrolled high blood pressure involving cellular-enabled home BP monitoring, medications, diet and exercise, and referral for social problems
Group II: Enhanced Usual CareActive Control1 Intervention
Home BP monitoring device provided along with BP log, basic diet and exercise instruction, and care provided by the patient's usual doctor/provider
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Who is running the clinical trial?
East Carolina UniversityLead Sponsor
107 Previous Clinical Trials
38,029 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
549 Previous Clinical Trials
29,995,996 Total Patients Enrolled
University of North Carolina, Chapel HillOTHER
1,504 Previous Clinical Trials
4,186,882 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities for individuals to partake in this clinical experiment?
"According to clinicaltrials.gov, this medical study is no longer actively recruiting patients. Initially posted on August 10th 2023 and last modified on September 11th 2023, the trial has shifted its focus elsewhere; however, there are presently 730 other studies welcoming new participants."
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