BP REACH Intervention for High Blood Pressure

(BP-REACH Trial)

Recruiting at 3 trial locations

Overseen By Monica Ayala-Rivera

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Southern California

Disqualifiers: Age < 35, Dementia, Aphasia, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

BP-REACH is a study of a team-based (pharmacist and health coach) program for lowering blood pressure for people with a prior stroke or heart attack in the Los Angeles Department of Health Services public healthcare system. The goal of this clinical trial is to test if this team based program is better at helping people reduce their blood pressure than usual care for people with prior heart attack or stroke. The main questions it aims to answer are: * Do people in the REACH BP program have lower blood pressure at 12 months compared to those getting usual care? * Do people in the REACH BP program have better Life's Essential 8 scores and patient experience compared to those getting usual care?

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 BP REACH Intervention treatment for high blood pressure?

Research shows that team-based approaches, patient education, and self-management strategies can significantly improve blood pressure control. For example, a study found that community-based education and empowerment interventions led to meaningful blood pressure reductions, especially in high-risk groups. ^{1 2 3 4 5}

Is the BP REACH Intervention safe for humans?

The available research does not provide specific safety data for the BP REACH Intervention or its other names, but team-based care approaches, which include similar interventions, are generally considered safe and focus on improving blood pressure management. ^{2 6 7 8 9}

How is the BP REACH Intervention for High Blood Pressure different from other treatments?

The BP REACH Intervention is unique because it uses mobile health (mHealth) technology, specifically SMS text messaging, to engage patients in self-measured blood pressure monitoring, which is a proven method to lower and control blood pressure. This approach is particularly focused on reaching medically underresourced patients, making it a scalable and accessible option compared to traditional treatments. ^{5 8 10 11 12}

Research Team

Alejandra Casillas, MD

Principal Investigator

University of California, Los Angeles

Amytis Towfighi, MD

Principal Investigator

University of Southern California

Eligibility Criteria

This trial is for English or Spanish speakers over 35 years old with high blood pressure (SBP ≥ 130 mm Hg) who have had a stroke or heart attack and are patients at specific LA medical centers. It's not for those who can't consent due to conditions like dementia.

Inclusion Criteria

Your systolic blood pressure is 130 or higher.

I speak English or Spanish.

I had a stroke or heart attack and am a patient at one of the specified medical centers.

Exclusion Criteria

Cannot provide informed consent due to dementia or aphasia

Your blood pressure is lower than 130 mm Hg.

I am under 35 years old.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline data collection including blood pressure, BMI, cholesterol, and other health metrics

1 week

1 visit (in-person)

Intervention

Participants receive a home blood pressure monitor, monthly coaching calls, and medication management by a pharmacist

12 months

Monthly phone calls

Follow-up

Participants are monitored for changes in blood pressure and other health metrics

12 months

3 visits (in-person) at Baseline, 3 months, and 12 months

Treatment Details

Interventions

• BP REACH Intervention (Behavioral Intervention)

Trial Overview The BP REACH Intervention, a team-based program involving pharmacists and health coaches, aims to lower blood pressure in people with past strokes or heart attacks. It will be compared to usual care over a period of 12 months.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Participants follow the intervention protocol, including receiving educational materials, a home blood pressure monitor, coaching calls from BP REACH coaches and medication management from a pharmacist.

Group II: Usual Care Active Control 1 Intervention

Participants receive the usual care received by patients of the medical center

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

University of California, Irvine

Collaborator

Trials

580

Recruited

4,943,000+

Findings from Research

In a study involving 139 African-American participants with chronic hypertension, 67% of those who completed the intervention achieved blood pressure control after 180 days, indicating a high overall success rate in managing hypertension.

Although the educational intervention did not significantly differ in effectiveness compared to the control group, factors like age and smoking status influenced the outcomes, suggesting that targeted approaches may be necessary for different patient demographics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of enhanced emergency department discharge for chronic hypertension management - Results of a randomized controlled trial. Gleason Comstock, J., Janisse, J., Streater, A., et al.[2022]

A community intervention targeting hypertension in predominantly racial/ethnic minority neighborhoods led to significant blood pressure improvements, especially in individuals with severely elevated blood pressure (≥160/100 mmHg), who saw a reduction from 165.4/98.3 mmHg to 150.4/90.8 mmHg.

After 3 months, 55.2% of participants with severely elevated blood pressure achieved controlled levels, demonstrating the effectiveness of education and empowerment strategies in managing hypertension in high-risk communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community Targeting of Uncontrolled Hypertension: Results of a Hypertension Screening and Education Intervention in Community Churches Serving Predominantly Racial/Ethnic Minority Populations. Prendergast, HM., Escobar-Schulz, S., Del Rios, M., et al.[2022]

Currently, only about 31% of hypertensive patients in the U.S. have their blood pressure controlled to the target level of < 140/90 mm Hg, highlighting a significant gap in hypertension management since the Healthy People 2010 goal aims for 50%.

Improving awareness, treatment, and control rates could potentially resolve barriers to hypertension management, suggesting that achieving 80% awareness, 90% treatment of aware patients, and 70% control among treated patients could meet the national goal for blood pressure control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlling blood pressure in 50% of all hypertensive patients: an achievable goal in the healthy people 2010 report? Egan, BM., Basile, JN.[2016]

Quality improvement strategies that effectively control blood pressure include team changes, patient education, and promoting self-management, highlighting the importance of a collaborative approach.

Barriers to blood pressure control can arise from patients, providers, and systems, suggesting that future research should focus on identifying the most effective components of these quality improvement interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing effective hypertension quality improvement strategies: barriers and potential solutions. Walsh, JM., Sundaram, V., McDonald, K., et al.[2021]

A telephonic outreach program significantly improved blood pressure control among patients with hypertension, with 32.5% of those receiving the intervention achieving control compared to 23.7% in the usual care group, based on a study involving over 64,000 participants.

Patients with pre-existing conditions like cardiovascular disease, chronic kidney disease, or diabetes benefited even more from the intervention, suggesting that targeted outreach could enhance BP management in high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of an automated telephone intervention to improve blood pressure control. Harrison, TN., Ho, TS., Handler, J., et al.[2021]

Team-based care involving nurses and pharmacists significantly improves blood pressure control, with education about medications leading to an average reduction of -8.75/-3.60 mm Hg in blood pressure.

Pharmacist interventions showed the largest effect on systolic blood pressure, with an average reduction of -9.30 mm Hg, while both nurses and pharmacists demonstrated similar efficacy in managing hypertension, suggesting that integrating these roles into healthcare can enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potency of team-based care interventions for hypertension: a meta-analysis. Carter, BL., Rogers, M., Daly, J., et al.[2022]

A study involving 3071 adults with moderately severe hypertension found that both clinic-based and telehealth care significantly reduced blood pressure over 12 months, with no significant difference in effectiveness between the two methods.

Patients receiving telehealth care reported higher satisfaction with their blood pressure management, including more frequent home monitoring and greater convenience, suggesting that telehealth is a safe and effective alternative to traditional clinic visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Pharmacist-Led Telehealth Care and Clinic-Based Care for Uncontrolled High Blood Pressure: The Hyperlink 3 Pragmatic Cluster-Randomized Trial. Margolis, KL., Bergdall, AR., Crain, AL., et al.[2023]

A 12-week salt reduction program significantly lowered blood pressure in adults, with an average decrease of -2.5 mm Hg in systolic blood pressure and -2.7 mm Hg in diastolic blood pressure, particularly benefiting those with high-normal blood pressure or hypertension.

While both the salt reduction and healthy lifestyle programs improved blood pressure, the salt reduction program was more effective, highlighting the importance of dietary quality in managing hypertension, especially through adherence to the Mediterranean diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empowerment-based nutrition interventions on blood pressure: a randomized comparative effectiveness trial. Moreira-Rosário, A., Ismael, S., Barreiros-Mota, I., et al.[2023]

The American Heart Association's Check. Change. CONTROL (CCC) program, involving 4069 patients across 18 cities, showed that community-based blood pressure interventions can be effectively scaled and customized, leading to significant improvements in blood pressure.

High enrollment and engagement at various sites were linked to successful outcomes, with effective strategies including hypertension education classes, distribution of blood pressure cuffs, and active follow-up with participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of a multi-community hypertension implementation study: the American Heart Association's Check. Change. Control. program. Anderson, ML., Peragallo Urrutia, R., O'Brien, EC., et al.[2021]

The Reach Out mHealth intervention, which uses SMS text messaging for self-measured blood pressure (SMBP) monitoring, was well-received by participants, indicating its potential effectiveness in engaging hypertensive patients in managing their blood pressure.

Participants with higher engagement levels had better understanding and social support, while those with lower engagement or who withdrew from the trial faced more health-related social needs, suggesting that addressing these needs could improve participation and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engagement in Self-measured Blood Pressure Monitoring Among Medically Underresourced Participants (the Reach Out Trial): Digital Framework Qualitative Study. Hellem, AK., Whitfield, C., Casetti, A., et al.[2023]

The ongoing randomized controlled trial involves 294 veterans with hypertension receiving a nurse-administered, patient-tailored intervention aimed at improving blood pressure control over 2 years, with a high retention rate of 97% after the first year.

At 6 months, participants in the nurse intervention group showed a significant increase in confidence regarding their hypertension treatment compared to those receiving usual care, indicating the intervention's potential effectiveness in promoting medication adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse administered telephone intervention for blood pressure control: a patient-tailored multifactorial intervention. Bosworth, HB., Olsen, MK., Gentry, P., et al.[2015]

The Reach Out Cognition study will assess the acceptability and feasibility of using digital tools for self-administered cognitive assessments and blood pressure monitoring in hypertensive patients, extending data collection from 12 months to 18 months for better insights.

This study focuses on a predominantly working-age Black American population, aiming to inform future clinical trials and improve remote monitoring strategies for hypertension and cognitive health, potentially addressing health disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supplement study update for Reach Out: a multi-arm randomized trial of behavioral interventions for hypertension initiated in the emergency department: Reach Out Cognition. Skolarus, LE., Dinh, M., Kidwell, KM., et al.[2021]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of enhanced emergency department discharge for chronic hypertension management - Results of a randomized controlled trial. [2022]

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

Community Targeting of Uncontrolled Hypertension: Results of a Hypertension Screening and Education Intervention in Community Churches Serving Predominantly Racial/Ethnic Minority Populations. [2022]

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

Controlling blood pressure in 50% of all hypertensive patients: an achievable goal in the healthy people 2010 report? [2016]

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

Implementing effective hypertension quality improvement strategies: barriers and potential solutions. [2021]

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

A randomized controlled trial of an automated telephone intervention to improve blood pressure control. [2021]

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

The potency of team-based care interventions for hypertension: a meta-analysis. [2022]

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

Comparing Pharmacist-Led Telehealth Care and Clinic-Based Care for Uncontrolled High Blood Pressure: The Hyperlink 3 Pragmatic Cluster-Randomized Trial. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Empowerment-based nutrition interventions on blood pressure: a randomized comparative effectiveness trial. [2023]

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

Outcomes of a multi-community hypertension implementation study: the American Heart Association's Check. Change. Control. program. [2021]

10. Canada pubmed.ncbi.nlm.nih.gov

Engagement in Self-measured Blood Pressure Monitoring Among Medically Underresourced Participants (the Reach Out Trial): Digital Framework Qualitative Study. [2023]

11. Ireland pubmed.ncbi.nlm.nih.gov

Nurse administered telephone intervention for blood pressure control: a patient-tailored multifactorial intervention. [2015]

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

Supplement study update for Reach Out: a multi-arm randomized trial of behavioral interventions for hypertension initiated in the emergency department: Reach Out Cognition. [2021]