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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
No Placebo-Only Group

Summary

This trial tests a program where patients with uncontrolled high blood pressure monitor their own blood pressure at home and attend group sessions to learn about healthy living. The goal is to see if this approach helps them manage their blood pressure better. Patients will track their blood pressure, diet, physical activity, and emotions, and receive support from doctors and therapists.

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~upto 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and upto 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hypertensive disease
Secondary study objectives
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 more
Other study objectives
Mindfulness
Sleeplessness
Change in the mean BP from 12 months before to 12 months after program participation.
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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
2022
N/A
~80

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for high blood pressure include medications and lifestyle changes. ACE inhibitors and ARBs work by relaxing blood vessels through the inhibition of the renin-angiotensin system, reducing blood pressure. Beta-blockers decrease heart rate and the force of contraction, lowering blood pressure. Calcium channel blockers prevent calcium from entering heart and blood vessel cells, leading to relaxed vessels. Diuretics help the body eliminate excess sodium and water, reducing blood volume and pressure. Lifestyle changes, such as a healthy diet, regular exercise, and stress management, are crucial as they address the root causes of hypertension. These mechanisms are important because they help prevent complications like heart disease and stroke. The self-monitoring and lifestyle education approach in the trial emphasizes patient involvement in managing their condition, which can lead to better adherence and outcomes.

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,056 Previous Clinical Trials
1,371,584 Total Patients Enrolled
The MetroHealth SystemUNKNOWN
4 Previous Clinical Trials
24,428 Total Patients Enrolled
Cleveland State UniversityOTHER
13 Previous Clinical Trials
3,509 Total Patients Enrolled

Media Library

Lifestyle Modifications Clinical Trial Eligibility Overview. Trial Name: NCT05604040 — N/A
High Blood Pressure Research Study Groups: Self-monitoring and education program for lifestyle changes
High Blood Pressure Clinical Trial 2023: Lifestyle Modifications Highlights & Side Effects. Trial Name: NCT05604040 — N/A
Lifestyle Modifications 2023 Treatment Timeline for Medical Study. Trial Name: NCT05604040 — N/A
~11 spots leftby Dec 2025