Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Cleveland State University | OTHER |
| MetroHealth System, Ohio | OTHER |
Not provided
Not provided
Not provided
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:
Participants will:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 12 weeks |
| Percentage of study participants that change from uncontrolled hypertension state to controlled hypertension state. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean Mindfulness Attention Awareness Scale | 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sonal J Patil, MD, MSPH | The Cleveland Clinic | Principal Investigator |
| Irina Todorov, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Beachwood | Ohio | 44107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32902588 | Background | 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. | |
| 34313678 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Change in the percentage of study participants with uncontrolled hypertension from before, during, and after the 6-week educational program participation will be evaluated. |
| Upto 12 weeks |
| 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:
| 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 | Investigators will measure percentage of enrolled patients with uncontrolled hypertension that:
| Up to 10 months |
| 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. | Up to 6 months |
| Upto 6 months |
| Change in mean insomnia severity index scale | Investigators will assess exploratory outcomes of changes in sleep using Insomnia severity Index scale; | Upto 6 months |
| Change in the mean number of vegetable and fruit serving intake | Investigators will assess exploratory outcomes of Change in number of vegetable and fruit serving intake; | Upto 6 months |
| Change in the mean number of minutes of physical activity per week | Investigators will assess exploratory outcomes of Change in the number of minutes of physical activity; | Upto 6 months |
| Change in the mean number of hypertension medications | 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 | Upto 12 months |
| Change in the mean BP from 12 months before to 12 months after program participation. | 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 | Upto 12 months |
| Patient and physician feedback on intervention | Investigators will gain insights into what worked what did not work for patients and referring primary care physicians | Upto 3 months |
| 31937533 | 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. |
| 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. |
| 26755778 | 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. |
| 34661634 | 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. |
| 35583869 | 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. |
| 24352797 | 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. |
| 39437225 | Derived | Patil SJ, Guo N, Udoh EO, Todorov I. Self-Monitoring With Coping Skills and Lifestyle Education for Hypertension Control in Primary Care. J Clin Hypertens (Greenwich). 2024 Dec;26(12):1487-1501. doi: 10.1111/jch.14921. Epub 2024 Oct 22. |