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Completed

NCT Number: NCT05604040

Home Blood Pressure Monitoring to Improve Hypertension

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Beachwood, Ohio, 44107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Lifestyle modifications

Behavioral

Home BP monitoring with self-monitoring of emotions, diet, physical activity, with shared medical appointment program for lifestyle changes and coping skills

Primary outcomes

  1. Percentage of patients with uncontrolled hypertension referred or self-referred for self-monitoring and lifestyle education program by physicians or patient self-referrals

    Time frame: Up to 10 months

    Investigators will measure the percentage of patients with uncontrolled hypertension that were referred or self-referred to and enrolled per month in the program for self-monitoring and lifestyle changes.

Secondary outcomes

  1. Change in mean BP measured by mm of Hg

    Time frame: Up to 12 weeks

    Change in average home BP in mm Hg from before, during, and after the 6-week educational program participation will be evaluated.

  2. Percentage of study participants that change from uncontrolled hypertension state to controlled hypertension state.

    Time frame: Upto 12 weeks

    Change in the percentage of study participants with uncontrolled hypertension from before, during, and after the 6-week educational program participation will be evaluated.

  3. Percentage of study participants that adhere to the self-monitoring and lifestyle education program

    Time frame: Up to 10 months

    Investigators will measure percentage of enrolled patients with uncontrolled hypertension that:

    • participated in at least 4 of the 6 weeks of education program
    • Preferred weekly educational materials instead of attending weekly shared medical appointments.
    • Sent self-reports of home BP at least 3days/week in 4 out of 6weeks

  4. Percentage of study participants that did not benefit from self-monitoring and lifestyle education program as measured by persisting high BP of more than 160/100 and need for additional medications

    Time frame: Up to 10 months

    Investigators will measure percentage of enrolled patients with uncontrolled hypertension that:

    • had persisting average home BP>160/100
    • needed additional medications

  5. Change in mean Self-efficacy scale

    Time frame: Up to 6 months

    The PROMIS Self-Efficacy for Managing Chronic Conditions item banks are well-validated and comprise of five domains, Self-Efficacy for Managing: Daily Activities, Symptoms, Medications and Treatments, Emotions, and Social Interactions. We will measure before, after the 6-week educational program participation, and 6 months later will be evaluated.

Other outcomes

  1. Change in mean Mindfulness Attention Awareness Scale

    Time frame: Upto 6 months

    Investigators will assess exploratory outcomes of changes in coping skills using Mindfulness Attention Awareness Scale; Insomnia severity Index scale; Change in number of vegetable and fruit serving intake; Change in the number of minutes of physical activity; Number of hypertension medications; Comparison of BP trends from 12 months before to 12 months after participating in the self-monitoring and education program

  2. Change in mean insomnia severity index scale

    Time frame: Upto 6 months

    Investigators will assess exploratory outcomes of changes in sleep using Insomnia severity Index scale;

  3. Change in the mean number of vegetable and fruit serving intake

    Time frame: Upto 6 months

    Investigators will assess exploratory outcomes of Change in number of vegetable and fruit serving intake;

  4. Change in the mean number of minutes of physical activity per week

    Time frame: Upto 6 months

    Investigators will assess exploratory outcomes of Change in the number of minutes of physical activity;

  5. Change in the mean number of hypertension medications

    Time frame: Upto 12 months

    Investigators will assess exploratory outcomes of change in Number of hypertension medications; Comparison of BP trends from 12 months before to 12 months after participating in the self-monitoring and education program

  6. Change in the mean BP from 12 months before to 12 months after program participation.

    Time frame: Upto 12 months

    Investigators will assess exploratory outcomes of change in Comparison of BP trends from 12 months before to 12 months after participating in the self-monitoring and education program

  7. Patient and physician feedback on intervention

    Time frame: Upto 3 months

    Investigators will gain insights into what worked what did not work for patients and referring primary care physicians

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • Cleveland State University
  • MetroHealth System, Ohio

Registry information

Official study title

Home BP Monitoring with Lifestyle Changes and Mindfulness Practices to Improve Hypertension Control

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Nov 3, 2022
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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