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Home Blood Pressure Monitoring + Lifestyle Education for High Blood Pressure
N/A
Waitlist Available
Led By Irina Todorov, MD
Research Sponsored by The Cleveland Clinic
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 upto 12 months
Awards & highlights
Study Summary
This trial will test if self-monitoring & lifestyle education can help people with uncontrolled hypertension improve their BP & hypertension control.
Who is the study for?
This trial is for patients with high blood pressure that isn't controlled by current treatments. They must own a smartphone, be willing to self-report their blood pressure, and be interested in trying lifestyle changes. People can't join if they have extremely high clinic BP readings, are on dialysis, pregnant, terminally ill or have had recent major heart events.Check my eligibility
What is being tested?
The study tests whether a program of home blood pressure monitoring combined with a 6-week support course on lifestyle modifications and coping skills can improve hypertension control. Participants will track their BP at home and attend educational sessions led by healthcare professionals.See study design
What are the potential side effects?
Since the intervention involves non-medical approaches like lifestyle education and self-monitoring rather than drugs or medical procedures, there are no direct side effects associated with typical clinical trials. However, participants may experience stress or discomfort from changing habits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ upto 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~upto 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hypertensive disease
Secondary outcome measures
Change in mean BP measured by mm of Hg
Change in mean Self-efficacy scale
Percentage of study participants that adhere to the self-monitoring and lifestyle education program
+2 moreOther outcome measures
Mindfulness
Sleeplessness
Change in the mean BP from 12 months before to 12 months after program participation.
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Self-monitoring and education program for lifestyle changesExperimental Treatment1 Intervention
Participants will send self-reports of their home BPs, diet, physical activity and emotions while attending a 6-week education program of lifestyle changes and coping skills. Participants will get summary reports of their home BP and lifestyle monitoring. Participants primary care physicians will be notified of persisting high BPs and final average home BP levels. Researchers will monitor home BP levels and change in hypertension control state
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lifestyle Modifications
2019
N/A
~50
Find a Location
Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
1,026 Previous Clinical Trials
1,366,016 Total Patients Enrolled
The MetroHealth SystemUNKNOWN
3 Previous Clinical Trials
37,900 Total Patients Enrolled
Cleveland State UniversityOTHER
12 Previous Clinical Trials
2,009 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood pressure is higher than 180 over 110.You are currently receiving dialysis treatment.You have a very serious illness that can't be cured.Your arm is too big for the largest home blood pressure monitor cuff.You have a serious problem with thinking and remembering things.Your blood pressure is not well controlled and is higher than 140 over 90 when measured at the clinic.You had a serious heart or blood vessel problem in the past 6 months, like heart disease, irregular heartbeats, or stroke.Your doctor suggests or you want to try monitoring your health at home and making lifestyle changes.
Research Study Groups:
This trial has the following groups:- Group 1: Self-monitoring and education program for lifestyle changes
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.
Are we still enrolling people for this experiment?
"That is correct, the clinical trial indicated on clinicaltrials.gov is currently looking for participants. The study was posted on October 14th, 2020 and updated on October 27th, 2020. They are hoping to enroll 60 patients from 1 site."
Answered by AI
How many people total will be allowed to join this clinical trial?
"That is correct. The information available on clinicaltrials.gov affirms that this study, which was originally uploaded on October 14th 2020, is still recruiting patients. Sixty individuals are needed from a single location."
Answered by AI
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