Self-Monitoring Strategies for High Blood Pressure

(INSPIRED Trial)

Overseen By Cindy Kim

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Pregnancy, Stroke, Cancer, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

330 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different strategies to help people with uncontrolled high blood pressure (hypertension) monitor their condition at home. It aims to determine the effectiveness and affordability of these strategies in safely managing blood pressure. Participants are divided into two groups: one receives usual care, while the other receives additional support through educational sessions and encouragement to involve family or friends in their health management. Individuals with recent high blood pressure readings at least twice and who receive care at one of the participating clinics may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to innovative strategies for managing hypertension.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these implementation strategies for self-measured blood pressure monitoring are safe?

Research shows that checking blood pressure at home, known as self-measured blood pressure monitoring (SMBP), is generally easy for people. This method involves using a monitor to check blood pressure independently. Studies have found that SMBP can help manage blood pressure better without significant side effects. It is safe because it doesn't involve medication or medical procedures.

This trial tests two different ways to help people monitor blood pressure at home. The first, simpler method includes training on using a blood pressure monitor, along with reminders and educational messages. The second, more involved method adds group sessions and encourages having a support person to assist.

Research on similar methods in the past has not shown any serious side effects. Checking blood pressure at home is a common and safe practice for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative self-monitoring strategies for managing high blood pressure. Unlike traditional treatments that rely heavily on medication and periodic doctor visits, this trial focuses on empowering patients through technology and education. The low-intensity approach provides patients with training on using blood pressure monitors and online portals, while the high-intensity method adds group education sessions and involves support persons in the management plan. This shift towards patient-centered care could lead to better blood pressure control and a more engaged patient experience.

What evidence suggests that these implementation strategies for self-measured blood pressure monitoring could be effective for high blood pressure?

Research has shown that checking blood pressure at home can help lower it. Studies have found that this method can lead to better blood pressure control. This trial will compare two self-monitoring strategies: a Low-Intensity Arm, which includes training on using a blood pressure monitor and receiving educational messages, and a High-Intensity Arm, which adds group educational sessions and support person involvement. Lowering blood pressure reduces the risk of heart disease and stroke. These strategies work well for many people, even those who may not have regular access to healthcare. Overall, self-monitoring effectively manages high blood pressure and improves long-term health. ^{6 7 8 9 10}

Who Is on the Research Team?

Elaine Khoong, MD, MS

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for individuals with high blood pressure, particularly from diverse racial and ethnic backgrounds. Participants should be interested in managing their hypertension through self-measured blood pressure monitoring and willing to engage with group classes, apps, online portals, and SMS reminders.

Inclusion Criteria

Any race or ethnicity

Must be receiving primary care at any of the six enrolled clinics

Can read and write English, Spanish, or Cantonese

Exclusion Criteria

Pregnancy (and 12 months postpartum)

Pacemaker use

I have not had a heart attack or stroke in the past year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation Strategy

Participants are randomized to low-intensity or high-intensity implementation strategies for self-monitored blood pressure monitoring

12 months

Monthly monitoring

Follow-up

Participants are monitored for effectiveness and safety of blood pressure control strategies

6 months

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Implementation Strategies for Self-Measured Blood Pressure Monitoring

Trial Overview The study tests how effective different strategies are at helping people control their blood pressure at home. It includes training on using a BP monitor and app, education on self-management of hypertension, support via text messages, and caregiver involvement.

How Is the Trial Designed?

Group I: High-Intensity Experimental Treatment 7 Interventions

Patient level: In addition to the Low-Intensity Arm strategies, patients will be asked to attend four educational group sessions with other trial patients. Patients will also be asked to involve support persons in their hypertension management. The educational messages that patients receive will also explicitly encourage involvement of a support person. Clinic level: training on standardized workflows and EHR tools, audit and feedback

Group II: Low-Intensity (Usual Care) Active Control 4 Interventions

Patient level: training on how to use a blood pressure (BP) monitor and online patient portal (ex. MyChart), receive reminders to take their BP at home, receive educational messages, and access to language-concordant educational materials. Clinic level: training on standardized workflows and EHR tools, audit and feedback

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

University of California, Davis

Collaborator

Trials

958

Recruited

4,816,000+

Beth Israel Deaconess Medical Center

Collaborator

Trials

872

Recruited

12,930,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Published Research Related to This Trial

The definition of an adverse drug event (ADE) should be tailored to the specific purpose of the evaluation, with stricter definitions needed for scientific studies and more flexible ones for clinical use.

Postmarketing safety data for drugs is limited at launch, but can be supplemented through systems like the FDA's Spontaneous Reporting System and targeted research projects, emphasizing the importance of robust epidemiological evidence for regulatory actions like drug recalls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug events: identification and attribution. Rogers, AS.[2022]

In a study involving 552 high-risk patients with hypertension, self-monitoring and self-titration of antihypertensive medication led to a significant reduction in systolic blood pressure by an average of 9.2 mm Hg compared to usual care after 12 months.

The self-management approach was effective across all patient subgroups and did not result in excessive adverse events, indicating it is a safe and beneficial strategy for managing blood pressure in patients with cardiovascular disease, diabetes, or chronic kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of self-monitoring and medication self-titration on systolic blood pressure in hypertensive patients at high risk of cardiovascular disease: the TASMIN-SR randomized clinical trial. McManus, RJ., Mant, J., Haque, MS., et al.[2023]

In a study of 31,757 Medicare enrollees over 12 months, 1,523 adverse drug events (ADEs) were identified, with 28% of these being preventable, highlighting a significant issue in medication safety for older patients.

The research revealed that relying solely on voluntary reporting from healthcare providers is insufficient for detecting ADEs, as only 11% of ADEs were identified through this method; thus, a combination of detection strategies is necessary for better safety monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for detecting adverse drug events among older persons in the ambulatory setting. Field, TS., Gurwitz, JH., Harrold, LR., et al.[2018]

The proposed three-part framework for analyzing adverse events includes phases for documenting incidents, conducting in-depth reviews, and assessing the association between exposure and adverse events, which can enhance product safety.

By standardizing the evaluation of adverse events through this framework, companies can better manage risks and improve consumer products based on reliable data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-market surveillance of consumer products: Framework for adverse event management. Kingston, R., Sioris, K., Gualtieri, J., et al.[2022]

In a study of 224 patients with hypertension over 12 months, self-monitoring blood pressure (SMBP) led to a significant average decrease in systolic blood pressure by 2.5 mm Hg compared to usual care.

The most notable benefit of SMBP was observed in patients aged 60 years and older, where their uncontrolled blood pressure rates dropped from 90.9% at baseline to 38.2% at month 12, indicating SMBP is particularly effective for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Self-Monitoring Blood Pressure in Primary Care: A Randomized Controlled Trial. Aekplakorn, W., Suriyawongpaisal, P., Tansirisithikul, R., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9399977/

Use of Self-Measured Blood Pressure Monitoring to ... The studies with clinical outcomes demonstrate that SMBP monitoring (a) can be successfully adopted by historically excluded patient populations and safety-net ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000000803

Self-Measured Blood Pressure Monitoring at Home: A Joint ... Evidence from meta-analyses of randomized trials indicates that self-measured BP monitoring is associated with a reduction in BP and improved BP ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2818560

Long-Term Effect of Home Blood Pressure Self-Monitoring ... However, BP reduction has proved to be a reliable surrogate end point, highly correlated with reduced morbidity and cardiovascular mortality.

4. stacks.cdc.gov stacks.cdc.gov/view/cdc/164208/cdc_164208_DS6.pdf

Systematic Review of Self-Measured Blood Pressure ... This systematic economic review describes how certain intervention aspects contribute to effectiveness, intervention cost, and intervention cost per unit of the ...

5. academic.oup.com academic.oup.com/ajh/article/33/3/243/5626378

Self-monitoring of Blood Pressure in Patients With ... Self-monitoring was associated with reduced clinic systolic BP compared to usual care at 12-month follow-up, regardless of the number of hypertension-related co ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41057081/?utm_source=FeedFetcher&utm_medium=rss&utm_campaign=None&utm_content=1hCS5QvDf5q2Rl21mSuOL2CLo33EslH5MTeVGiFhdt-eWogQZ&fc=None&ff=20251031195915&v=2.18.0.post22+67771e2

Implementation Strategies for Self-Measured Blood ... The results of this trial will address gaps in identifying cost-conscious implementation strategies for increasing adoption of SMBP in ...

7. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06871462

Implementation Strategies for Self-Measured Blood ... This study will focus on assessing implementation strategies to increase adoption of self-monitored blood pressure (SMBP) monitoring among low-income, ...

8. ahajournals.org ahajournals.org/doi/10.1161/HYP.0000000000000232

Implementation Strategies to Improve Blood Pressure ... Key areas for implementation include antiracism efforts; accurate BP measurement; team-based care; lifestyle modification programs at the ...

9. researchgate.net researchgate.net/publication/396246509_Implementation_strategies_for_self-measured_blood_pressure_monitoring_in_racially_and_ethnically_diverse_populations_InSPIRED_A_study_protocol

Implementation Strategies for Self-Measured Blood ... Self-Measured Blood Pressure Monitoring Improves Outcomes: Recommendation of the Community Preventive Services Task Force. Article. Sep 2017 ...

10. soar.usa.edu soar.usa.edu/cgi/viewcontent.cgi?article=1124&context=scholprojects

Implementing a Self-measured Blood Pressure Monitoring ... The evidence search strategy for this project involved using three databases: CINAHL Complete, PubMed, and Joanna Briggs Institute EBP Database.