Home Blood Pressure Monitoring to Improve Hypertension

NeuroTherapia, Inc.

Status: Completed

Conditions: Hypertension

Treatments: Behavioral: Lifestyle Modifications

Study type: Interventional

Funder types: Other

Identifiers

NCT05604040

00169

Details and patient eligibility

About

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.

Full description

Participants will be taught the proper use of Home BP machines using a teach-back technique. Patients will be loaned valid home BP machines.

Participants will be taught how to send self-reports of their home BP, diet, physical activity and emotions using an app on their phone.

Participants will be signed up for a 6-week educational program of lifestyle changes and coping skills delivered by physicians, holistic psychotherapists and yoga therapists.

Participants will receive summary reports of their Home BP, lifestyle and emotions.

Researchers will monitor home BP levels and any adverse effects. Primary care physicians of the patients with persisting high BP levels will be notified of their average home BPs. Patients will complete surveys that assess their ability to self-manage their hypertension, emotions, and social connections. Change in average home BP from before, during, and after 6-week educational program participation will be evaluated. Final average home BP and clinic BP notifications will be sent to the primary care physicians of all patients.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Self-monitoring and education program for lifestyle changes

Experimental group

Description:

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:

Behavioral: Lifestyle Modifications