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

Trial Summary

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 data supports the effectiveness of the treatment Implementation Strategies for Self-Measured Blood Pressure Monitoring?

Research shows that self-monitoring blood pressure (SMBP) can significantly help manage high blood pressure, with one study finding that about half of the patients achieved controlled blood pressure after using SMBP, and their blood pressure readings decreased notably. ^{1 2 3 4 5}

Is self-monitoring of blood pressure safe for humans?

The research articles provided do not contain specific safety data about self-monitoring strategies for high blood pressure, but they discuss general methods for identifying adverse events related to medications and consumer products. ^{6 7 8 9 10}

How does self-monitoring of blood pressure differ from other treatments for high blood pressure?

Self-monitoring of blood pressure is unique because it involves patients measuring their own blood pressure at home, which can lead to better awareness and adherence to treatment. This approach empowers patients to manage their condition more actively and can result in improved blood pressure control compared to traditional methods that rely solely on clinic visits. ^{11 12 13 14 15}

What is the purpose of this trial?

This clinical trial aims to assess the impact of patient-focused and clinical-focused implementation strategies on blood pressure control. The investigators will assess the costs of these strategies and how effective they were at safely and equitably increasing home blood pressure monitoring.

Research Team

Elaine Khoong, MD, MS

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Self-Monitoring Blood Pressure in Primary Care: A Randomized Controlled Trial. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Integrating self blood pressure monitoring into the routine management of uncontrolled hypertension: translating evidence to practice. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Knowledge and practice outcomes after home blood pressure measurement education programs. [2012]

4. England pubmed.ncbi.nlm.nih.gov

Home blood pressure self-monitoring: diagnostic performance in white-coat hypertension. [2006]

5. Spain pubmed.ncbi.nlm.nih.gov

[Effectiveness of self-monitoring of blood pressure in white coat hypertension diagnosis. Rationale and design]. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse drug events: identification and attribution. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Adverse events in the treatment of hypertensive patients. [2004]

8. England pubmed.ncbi.nlm.nih.gov

Strategies for detecting adverse drug events among older persons in the ambulatory setting. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Screening for Adverse Drug Events: a Randomized Trial of Automated Calls Coupled with Phone-Based Pharmacist Counseling. [2020]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Post-market surveillance of consumer products: Framework for adverse event management. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Systematic Review of Self-Measured Blood Pressure Monitoring With Support: Intervention Effectiveness and Cost. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Does self-monitoring reduce blood pressure? Meta-analysis with meta-regression of randomized controlled trials. [2022]

13. United States 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. [2023]

14. Ireland pubmed.ncbi.nlm.nih.gov

Self-monitoring blood pressure in hypertension, patient and provider perspectives: A systematic review and thematic synthesis. [2022]

15. United States pubmed.ncbi.nlm.nih.gov

Self-blood pressure monitoring is associated with improved awareness, adherence, and attainment of target blood pressure goals: Prospective observational study of 7751 patients. [2021]