Clinical trial NCT05604040: Home Blood Pressure Monitoring to Improve Hypertension
Official title: Home BP Monitoring with Lifestyle Changes and Mindfulness Practices to Improve Hypertension Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: blood pressure monitoring, home
shared medical appointments
lifestyle changes
coping skills
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Cleveland State University
name: MetroHealth System, Ohio
First posted: 2022-11-03
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of patients with uncontrolled hypertension referred or self-referred for self-monitoring and lifestyle education program by physicians or patient self-referrals
timeFrame: Up to 10 months
Secondary outcomes:
measure: Change in mean BP measured by mm of Hg
timeFrame: Up to 12 weeks
measure: Percentage of study participants that change from uncontrolled hypertension state to controlled hypertension state.
timeFrame: Upto 12 weeks
measure: Percentage of study participants that adhere to the self-monitoring and lifestyle education program
timeFrame: Up to 10 months
measure: 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
timeFrame: Up to 10 months
measure: Change in mean Self-efficacy scale
timeFrame: Up to 6 months
Other outcomes:
measure: Change in mean Mindfulness Attention Awareness Scale
timeFrame: Upto 6 months
measure: Change in mean insomnia severity index scale
timeFrame: Upto 6 months
measure: Change in the mean number of vegetable and fruit serving intake
timeFrame: Upto 6 months
measure: Change in the mean number of minutes of physical activity per week
timeFrame: Upto 6 months
measure: Change in the mean number of hypertension medications
timeFrame: Upto 12 months
measure: Change in the mean BP from 12 months before to 12 months after program participation.
timeFrame: Upto 12 months
measure: Patient and physician feedback on intervention
timeFrame: Upto 3 months
Locations:
city: Beachwood
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Sonal J Patil, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Irina Todorov, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Muntner P, Hardy ST, Fine LJ, Jaeger BC, Wozniak G, Levitan EB, Colantonio LD. Trends in Blood Pressure Control Among US Adults With Hypertension, 1999-2000 to 2017-2018. JAMA. 2020 Sep 22;324(12):1190-1200. doi: 10.1001/jama.2020.14545.
citation: Muntner P, Hardy ST. Together, We've Got This: The US Surgeon General's Call-to-Action on Hypertension Control. Am J Hypertens. 2021 Sep 22;34(9):893-894. doi: 10.1093/ajh/hpaa172. No abstract available.
citation: Patil SJ, Wareg NK, Hodges KL, Smith JB, Kaiser MS, LeFevre ML. Home Blood Pressure Monitoring in Cases of Clinical Uncertainty to Differentiate Appropriate Inaction From Therapeutic Inertia. Ann Fam Med. 2020 Jan;18(1):50-58. doi: 10.1370/afm.2491.
citation: Patil S, Bhayani, V., Yoshida,Y., LA; Wilson, G., Stange, KC., Saper, R. A RE-AIM Evaluation of Lay Advisor Interventions to Improve Hypertension Outcomes - A Systematic Review. presented at: American Heart Association Annual (AHA) Scientific Sessions 2021; 2021; Session QCOR at Sessions: Quality of Care and Outcomes Research.
citation: Liaw WR, Jetty A, Petterson SM, Peterson LE, Bazemore AW. Solo and Small Practices: A Vital, Diverse Part of Primary Care. Ann Fam Med. 2016 Jan-Feb;14(1):8-15. doi: 10.1370/afm.1839.
citation: Tajeu GS, Tsipas S, Rakotz M, Wozniak G. Cost-Effectiveness of Recommendations From the Surgeon General's Call-to-Action to Control Hypertension. Am J Hypertens. 2022 Mar 8;35(3):225-231. doi: 10.1093/ajh/hpab162.
citation: Nguyen-Huynh MN, Young JD, Ovbiagele B, Alexander JG, Alexeeff S, Lee C, Blick N, Caan BJ, Go AS, Sidney S. Effect of Lifestyle Coaching or Enhanced Pharmacotherapy on Blood Pressure Control Among Black Adults With Persistent Uncontrolled Hypertension: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2022 May 2;5(5):e2212397. doi: 10.1001/jamanetworkopen.2022.12397.
citation: James PA, Oparil S, Carter BL, Cushman WC, Dennison-Himmelfarb C, Handler J, Lackland DT, LeFevre ML, MacKenzie TD, Ogedegbe O, Smith SC Jr, Svetkey LP, Taler SJ, Townsend RR, Wright JT Jr, Narva AS, Ortiz E. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014 Feb 5;311(5):507-20. doi: 10.1001/jama.2013.284427.