Home Blood Pressure Monitoring to Improve Hypertension

NCT05604040 | Completed

• 1 other identifier: 00169
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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:

• 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.

Conditions

Hypertension

Keywords

blood pressure monitoring, home; shared medical appointments; lifestyle changes; coping skills

Outcome Measures

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

  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.

  Up to 10 months

Secondary Outcomes (5)

• Change in mean BP measured by mm of Hg

  Up to 12 weeks

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

  Upto 12 weeks

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

  Up to 10 months

• 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

  Up to 10 months

• Change in mean Self-efficacy scale

  Up to 6 months

Other Outcomes (7)

• Change in mean Mindfulness Attention Awareness Scale

  Upto 6 months

• Change in mean insomnia severity index scale

  Upto 6 months

• Change in the mean number of vegetable and fruit serving intake

  Upto 6 months

Study Arms (1)

Self-monitoring and education program for lifestyle changes

EXPERIMENTAL

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

Behavioral: Lifestyle Modifications

Interventions

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

Self-monitoring and education program for lifestyle changes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Cleveland State University: collaborator
• MetroHealth System, Ohio: collaborator

Study Sites (1)

Cleveland Clinic

Beachwood, Ohio, 44107, United States

Location

Related Publications (8)

• 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.

  PMID: 32902588 BACKGROUND

• 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.

  PMID: 34313678 BACKGROUND

• 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.

  PMID: 31937533 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 26755778 BACKGROUND

• 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.

  PMID: 34661634 BACKGROUND

• 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.

  PMID: 35583869 BACKGROUND

• 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.

  PMID: 24352797 BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sonal J Patil, MD, MSPH

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Irina Todorov, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Department of Wellness and Preventative Medicine

Study Record Dates

• First Submitted: October 9, 2022
• First Posted: November 3, 2022
• Study Start: October 14, 2022
• Primary Completion: June 16, 2023
• Study Completion: June 16, 2024
• Last Updated: November 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)