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Home Blood Pressure Monitoring to Improve Hypertension

Primary Purpose

Hypertension

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Modifications
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension focused on measuring blood pressure monitoring, home, shared medical appointments, lifestyle changes, coping skills

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Self-monitoring and education program for lifestyle changes

Arm 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in mean BP measured by mm of Hg
Change in average home BP in mm Hg from before, during, and after the 6-week educational program participation will be evaluated.
Percentage of study participants that change from uncontrolled hypertension state to controlled hypertension state.
Change in the percentage of study participants with uncontrolled hypertension from before, during, and after the 6-week educational program participation will be evaluated.
Percentage of study participants that adhere to the self-monitoring and lifestyle education program
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
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
Investigators will measure percentage of enrolled patients with uncontrolled hypertension that: had persisting average home BP>160/100 needed additional medications
Change in mean Self-efficacy scale
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.

Full Information

First Posted
October 9, 2022
Last Updated
September 8, 2023
Sponsor
The Cleveland Clinic
Collaborators
Cleveland State University, The MetroHealth System
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1. Study Identification

Unique Protocol Identification Number
NCT05604040
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 14, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
Collaborators
Cleveland State University, The MetroHealth System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
blood pressure monitoring, home, shared medical appointments, lifestyle changes, coping skills

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Self-monitoring and education program for lifestyle changes
Arm Type
Experimental
Arm 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
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Modifications
Intervention Description
Home BP monitoring with self-monitoring of emotions, diet, physical activity, with shared medical appointment program for lifestyle changes and coping skills
Primary Outcome Measure Information:
Title
Percentage of patients with uncontrolled hypertension referred or self-referred for self-monitoring and lifestyle education program by physicians or patient self-referrals
Description
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.
Time Frame
Up to 10 months
Secondary Outcome Measure Information:
Title
Change in mean BP measured by mm of Hg
Description
Change in average home BP in mm Hg from before, during, and after the 6-week educational program participation will be evaluated.
Time Frame
Up to 12 weeks
Title
Percentage of study participants that change from uncontrolled hypertension state to controlled hypertension state.
Description
Change in the percentage of study participants with uncontrolled hypertension from before, during, and after the 6-week educational program participation will be evaluated.
Time Frame
Upto 12 weeks
Title
Percentage of study participants that adhere to the self-monitoring and lifestyle education program
Description
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
Time Frame
Up to 10 months
Title
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
Description
Investigators will measure percentage of enrolled patients with uncontrolled hypertension that: had persisting average home BP>160/100 needed additional medications
Time Frame
Up to 10 months
Title
Change in mean Self-efficacy scale
Description
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.
Time Frame
Up to 6 months
Other Pre-specified Outcome Measures:
Title
Change in mean Mindfulness Attention Awareness Scale
Description
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
Time Frame
Upto 6 months
Title
Change in mean insomnia severity index scale
Description
Investigators will assess exploratory outcomes of changes in sleep using Insomnia severity Index scale;
Time Frame
Upto 6 months
Title
Change in the mean number of vegetable and fruit serving intake
Description
Investigators will assess exploratory outcomes of Change in number of vegetable and fruit serving intake;
Time Frame
Upto 6 months
Title
Change in the mean number of minutes of physical activity per week
Description
Investigators will assess exploratory outcomes of Change in the number of minutes of physical activity;
Time Frame
Upto 6 months
Title
Change in the mean number of hypertension medications
Description
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
Time Frame
Upto 12 months
Title
Change in the mean BP from 12 months before to 12 months after program participation.
Description
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
Time Frame
Upto 12 months
Title
Patient and physician feedback on intervention
Description
Investigators will gain insights into what worked what did not work for patients and referring primary care physicians
Time Frame
Upto 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonal J Patil, MD, MSPH
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Irina Todorov, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32902588
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.
Results Reference
background
PubMed Identifier
34313678
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.
Results Reference
background
PubMed Identifier
31937533
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
30724898
Citation
Patil SJ, Koopman RJ, Belden J, LeFevre M. The role of home BP monitoring: Answers to 10 common questions. J Fam Pract. 2019 Jan/Feb;68(1):29-33.
Results Reference
background
PubMed Identifier
35385435
Citation
Patil SJ, Tallon E, Wang Y, Nayyar M, Hodges K, Phad A, Rodriguez E, Gefter L. Effect of Stanford Youth Diabetes Coaches' Program on Youth and Adults in Diverse Communities. Fam Community Health. 2022 Jul-Sep 01;45(3):178-186. doi: 10.1097/FCH.0000000000000323. Epub 2022 Apr 5.
Results Reference
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PubMed Identifier
26755778
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.
Results Reference
background
PubMed Identifier
34661634
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.
Results Reference
background
PubMed Identifier
35583869
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.
Results Reference
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PubMed Identifier
24352797
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. Erratum In: JAMA. 2014 May 7;311(17):1809.
Results Reference
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PubMed Identifier
31060074
Citation
Byrd JB, Brook RD. Hypertension. Ann Intern Med. 2019 May 7;170(9):ITC65-ITC80. doi: 10.7326/AITC201905070.
Results Reference
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Home Blood Pressure Monitoring to Improve Hypertension

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