Home Blood Pressure Monitoring to Improve Hypertension (NCT05604040) | Clinical Trial Compass
CompletedNot Applicable
Home Blood Pressure Monitoring to Improve Hypertension
United States33 participantsStarted 2022-10-14
Plain-language summary
The goal of this single group pre-post-study is to test the possibility of self-monitoring with shared medical appointments program for lifestyle education in improving blood pressure (BP) of patients with uncontrolled hypertension.
The main questions it aims to address is:
1. To assess if patients with uncontrolled hypertension and their physicians will be interested in trying a program that includes self-monitoring with 6-week support for lifestyle changes and coping skills to improve BP and hypertension control.
2. To assess if patients with uncontrolled hypertension can safely participate in a program that includes self-monitoring with 6-week support for lifestyle changes and coping skills to improve their BP and ability to self-manage hypertension
Participants will:
* Send self-reports of their home BPs, diet, physical activity and emotions
* Attend 6-week education program of lifestyle changes and coping skills delivered by physicians, holistic psychotherapists and yoga therapists.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Uncontrolled hypertension based on Clinic BP measurement of systolic BP\>140 or diastolic BP \>90 mm Hg (as the cutoff in the current common hypertension performance measures and ACO metrics)
* PCP recommends or patient desires a trial of self-monitoring and lifestyle modifications
* Patient owns a smart phone and be willing to complete self-reports of BP during study participation.
Exclusion Criteria:
* On dialysis
* Pregnant
* Have a terminal illness,
* Clinic BP \> systolic\>180, diastolic\>110
* Arm circumference that exceeds the limit for the largest home BP monitor cuff
* Severe cognitive impairment
* Major cardiovascular or cerebrovascular event in the past 6 months (Coronary artery disease, heart valve problems, arrhythmias, heart failure, stroke)
* Any physical or mental impairment that would affect patients' ability to participate(Ability to participate will be assessed by demonstrated ability to use available home BP machine and complete self-report during recruitment).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of patients with uncontrolled hypertension referred or self-referred for self-monitoring and lifestyle education program by physicians or patient self-referrals