HypertensionNCT05604040
Home Blood Pressure Monitoring to Improve Hypertension
A study testing Lifestyle Modifications in people with Hypertension, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Lifestyle Modifications
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2022to 16 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Home BP Monitoring with Lifestyle Changes and Mindfulness Practices to Improve Hypertension Control
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:
Read more
- 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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Lifestyle Modifications
- Keywords
- blood pressure monitoring, home, shared medical appointments, lifestyle changes, coping skills
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle ModificationsBehavioural
Home BP monitoring with self-monitoring of emotions, diet, physical activity, with shared medical appointment program for lifestyle changes and coping skills
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Lifestyle Modifications |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 10 months
Secondary outcomes (5)
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.
Measured: Up to 12 weeks
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.
Measured: 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:
- 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
Measured: 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:
- had persisting average home BP>160/100
- needed additional medications
Measured: 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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start14 Oct 2022
- Primary completion16 Jun 2023
- Study completion16 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Cleveland State University, MetroHealth System, Ohio
- Responsible party
- Principal investigator, Irina Todorov, MD, The Cleveland Clinic
- Investigators
- Sonal J Patil, MD, MSPH, Principal investigator, The Cleveland ClinicIrina Todorov, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604040
- Sponsor's protocol ID
- 00169
- Status last verified
- Sep 2024
- First submitted
- 9 Oct 2022
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32902588Muntner 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.
PubMed 34313678Patil 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.
PubMed 31937533Patil 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.
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.
PubMed 26755778Tajeu 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.
PubMed 34661634Nguyen-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.
PubMed 35583869James 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.
PubMed 24352797Patil 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.
PubMed 39437225
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home BP Monitoring with Lifestyle Changes and Mindfulness Practices to Improve Hypertension Control
- ClinicalTrials.gov ID
- NCT05604040
- Acronym / sponsor ID
- 00169
- Conditions
- Hypertension
- Keywords
- blood pressure monitoring, home, shared medical appointments, lifestyle changes, coping skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Cleveland State University, MetroHealth System, Ohio
- Study start
- 14 Oct 2022 (actual)
- Primary completion
- 16 Jun 2023 (actual)
- Study completion
- 16 Jun 2024 (actual)
- First posted
- 3 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self-monitoring and education program for lifestyle changes | Experimental | Behavioral: Lifestyle ModificationsParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle ModificationsHome BP monitoring with self-monitoring of emotions, diet, physical activity, with shared medical appointment program for lifestyle changes and coping skills | Behavioural | Self-monitoring and education program for lifestyle changes |
Primary outcome
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.
5 secondary outcomes
Change in mean BP measured by mm of Hg
Time frame: Up to 12 weeks
Percentage of study participants that change from uncontrolled hypertension state to controlled hypertension state.
Time frame: Upto 12 weeks
Percentage of study participants that adhere to the self-monitoring and lifestyle education program
Time frame: 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
Time frame: Up to 10 months
Change in mean Self-efficacy scale
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Background: PubMed 32902588Muntner 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.
- Background: PubMed 34313678Muntner 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.
- Background: PubMed 31937533Patil 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.
- BackgroundPatil 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: PubMed 26755778Liaw 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.
- Background: PubMed 34661634Tajeu 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.
- Background: PubMed 35583869Nguyen-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.
- Background: PubMed 24352797James 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.
- Derived from this study: PubMed 39437225Patil 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonal J Patil, MD, MSPH principal investigator
The Cleveland Clinic
Irina Todorov, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Modifications in people with Hypertension, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05604040, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.