Targeted Home Visits for High Blood Pressure

Overseen By Silvia Obregon, MSW

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Oral steroids

Disqualifiers: Organ transplant, others

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

Compensation: Varies

Number of Visits: 2

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of study is to evaluate whether home visit programs are an effective method for HTN and T2DM management as compared to standard of care clinic visits.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using oral steroids, you cannot participate in the trial.

What data supports the effectiveness of the treatment Home visit for high blood pressure?

Research shows that home-based interventions, like home visits, can improve blood pressure control by involving healthcare professionals in monitoring and adjusting treatment plans. Studies have demonstrated that home blood pressure monitoring and personalized care, such as phone calls from care managers, can lead to better medication adherence and blood pressure management. ^{1 2 3 4 5}

Is home blood pressure monitoring safe for humans?

The research does not specifically address safety concerns, but home blood pressure monitoring is commonly used and considered safe for managing high blood pressure. ^{6 7 8 9 10}

How is the home visit treatment for high blood pressure different from other treatments?

The home visit treatment for high blood pressure is unique because it involves healthcare professionals visiting patients at home to monitor blood pressure and provide personalized care, which can lead to better management and control of blood pressure compared to traditional office-based visits. This approach allows for more consistent monitoring and can improve adherence to treatment plans, especially in underserved populations. ^{1 3 7 10 11}

Research Team

Nora Gimpel, M.D.

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

This trial is for adults aged 18-60 who speak English or Spanish and have high blood pressure (BP >140/90 in the last 3 months) or poorly controlled Type 2 Diabetes (Hemoglobin A1C>8 in the last 6 months). Pregnant individuals, those on oral steroids, or with a history of organ transplant cannot participate.

Inclusion Criteria

I have been diagnosed with high blood pressure or had readings above 140/90 in the last 3 months.

Your average blood sugar level has been very high in the last 6 months.

Not pregnant

Exclusion Criteria

I speak a language other than English or Spanish.

I have had a solid organ transplant.

I am currently taking oral steroids.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Home Visit

Participants receive two home visits for comprehensive assessment and management of hypertension and type 2 diabetes

6 months

2 home visits

Follow-up

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

6 months

Treatment Details

Interventions

• Home visit

Trial Overview The study is testing if home visits can better manage chronic conditions like high blood pressure and Type 2 Diabetes compared to usual care received at clinics. Participants will receive targeted home visits as part of their treatment plan.

Participant Groups

Group I: Home Visit Experimental Treatment 1 Intervention

Participants will receive home visit During the course of the first home visit, patients will receive routine care for diabetes and hypertension management (outcome variables are listed below) and data will be recorded in the EHR for primary outcomes. The resident physician will also assist the patient in completing enrollment in MyChart (if interested), utilizing either the resident's computer or smartphone and an internet hotspot. MyChart is a patient health platform that allows patients to contact their healthcare doctors, log health reminders, see test results, and a list of medications. The resident physician will also review a social determinants of health (SDH) screener (included in the EHR). The research faculty (licensed medical clinician) will collect blood pressure readings during this visit.

Group II: Standard of care Active Control 1 Intervention

Participants will receive a standard of care

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Findings from Research

Only 32.5% of the 83 hypertensive patients on multiple antihypertensive medications achieved controlled blood pressure, indicating a significant number are not meeting treatment goals.

Patients with uncontrolled hypertension, including those with the white-coat effect and masked hypertension, showed greater target organ damage, such as increased left ventricular mass index and carotid intima media thickness, compared to those with controlled blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical utility of home blood pressure monitoring in patients under treatment]. Bauk, L., Costa, HA., Caligiuri, SI.[2018]

A physician-nurse team model, utilizing home blood pressure monitoring, significantly improved long-term hypertension control, with the percentage of patients achieving target blood pressure levels rising from 0% to 63% over 12 months.

The study involved 106 patients, and results showed a notable decrease in mean blood pressure from 156/85 mm Hg at baseline to 131/75 mm Hg at 12 months, indicating effective management and adjustment of antihypertensive medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved blood pressure control with a physician-nurse team and home blood pressure measurement. Canzanello, VJ., Jensen, PL., Schwartz, LL., et al.[2013]

The Home-Based BP Intervention for Blacks study is a randomized controlled trial involving 312 nurses and 845 hypertensive patients, aimed at improving blood pressure management in a vulnerable home care population.

Two intervention strategies are being tested: a basic intervention with evidence-based reminders and an augmented intervention that includes ongoing support for 12 months, with outcomes measured at 3 and 12 months to evaluate their effectiveness compared to usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based blood pressure interventions for blacks. Feldman, PH., McDonald, MV., Mongoven, JM., et al.[2022]

A tailored multifaceted program for 558 Medicaid patients significantly improved hypertension medication adherence, with the medication possession ratio (MPR) increasing from 55% to 77% after 12 months.

The program's success was attributed to personalized phone interactions by care managers, which addressed individual concerns and barriers, demonstrating sustainable improvements in medication adherence over the year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a self-management implementation intervention to improve hypertension control among patients in Medicaid. Bosworth, HB., Dubard, CA., Ruppenkamp, J., et al.[2021]

A cohort study involving 432 patients with hypertension showed that home telehealth care combined with public health nurse case management led to an average reduction of 22.1 mm Hg in systolic blood pressure over one year, indicating its effectiveness in blood pressure control.

The study found that older patients and those who frequently monitored their blood pressure were more likely to experience a decrease in systolic blood pressure, suggesting that self-monitoring behavior plays a crucial role in managing hypertension effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of home telehealth care on blood pressure control: A public healthcare centre model. Lu, JF., Chen, CM., Hsu, CY.[2019]

A new electronic health record (EHR)-integrated visualization tool for reviewing home blood pressure readings during primary care visits was found to enhance communication and decision-making between physicians and patients, compared to traditional paper methods.

The study involved 73 patients and showed that using the visualization tool made discussions about blood pressure management easier and quicker, highlighting the importance of having the right infrastructure for effective hypertension management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Home Blood Pressure Data Visualization on Hypertension Medical Decision Making in Primary Care. Cohen, DJ., Wyte-Lake, T., Canfield, SM., et al.[2022]

Home blood pressure monitoring (HBPM) significantly improved blood pressure control compared to standard office-based management, with systolic BP decreasing from 159/91 mmHg to 138/80 mmHg in the HBPM group.

The study involved 270 subjects and showed that while both groups experienced reductions in blood pressure, the HBPM group had a statistically greater decrease, indicating that HBPM may enhance physician-initiated medication adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IMPPACT: Investigation of Medical Professionals and Patients Achieving Control Together. Tobe, SW., Hunter, K., Geerts, R., et al.[2021]

A new data visualization display for home blood pressure measurements was developed to enhance shared decision-making between hypertensive patients and healthcare providers, based on feedback from 40 participants in focus groups.

The display features user-friendly elements like a line graph, color-coded goal ranges, and a medication timeline, which can help patients and providers better understand blood pressure trends and improve treatment decisions for the 35 million Americans with uncontrolled hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home blood pressure data visualization for the management of hypertension: using human factors and design principles. Wegier, P., Belden, JL., Canfield, SM., et al.[2023]

Home blood pressure (HBP) measurements are more reliable for diagnosing hypertension compared to office blood pressure (OBP) and ambulatory blood pressure (ABP), and they correlate better with left ventricular mass index, which is important for heart health.

Higher systolic HBP is linked to increased risks of all-cause mortality and cardiovascular events, while ABP is a better predictor of cardiovascular risks in diabetic patients, suggesting that both HBP and ABP provide valuable information beyond what OBP can offer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methods of Blood Pressure Measurement to Predict Hypertension-Related Cardiovascular Morbidity and Mortality. Htay, T., Rosado, D., Quest, D., et al.[2022]

Home blood pressure monitoring is as effective as 24-hour ambulatory monitoring in predicting damage to target organs in untreated hypertensive patients, based on a study of 68 participants.

Home blood pressure measurements showed stronger correlations with left-ventricular mass index (LVMI) compared to office blood pressure readings, indicating that home monitoring may provide a better assessment of hypertension-related organ damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home blood pressure is as reliable as ambulatory blood pressure in predicting target-organ damage in hypertension. Stergiou, GS., Argyraki, KK., Moyssakis, I., et al.[2022]

Only 45.6% of patients with hypertension achieved their target blood pressure goals, with even lower rates of 27.6% for those with diabetes and 21.1% for chronic kidney disease, indicating a significant gap in effective management.

A substantial number of patients with diabetes (16%), chronic kidney disease (26%), and heart failure (24.1%) were not prescribed recommended medications like ACE inhibitors or ARBs, highlighting a need for better adherence to JNC 7 guidelines in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compliance with Joint National Committee 7 guidelines in hypertension management in a teaching institution. Jami, P., Smith, P., Moningi, S., et al.[2007]

References

1. Spain pubmed.ncbi.nlm.nih.gov

[Clinical utility of home blood pressure monitoring in patients under treatment]. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Improved blood pressure control with a physician-nurse team and home blood pressure measurement. [2013]

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

Home-based blood pressure interventions for blacks. [2022]

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

Evaluation of a self-management implementation intervention to improve hypertension control among patients in Medicaid. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Effect of home telehealth care on blood pressure control: A public healthcare centre model. [2019]

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

Impact of Home Blood Pressure Data Visualization on Hypertension Medical Decision Making in Primary Care. [2022]

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

IMPPACT: Investigation of Medical Professionals and Patients Achieving Control Together. [2021]

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

Home blood pressure data visualization for the management of hypertension: using human factors and design principles. [2023]

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

Methods of Blood Pressure Measurement to Predict Hypertension-Related Cardiovascular Morbidity and Mortality. [2022]

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

Home blood pressure is as reliable as ambulatory blood pressure in predicting target-organ damage in hypertension. [2022]

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

Compliance with Joint National Committee 7 guidelines in hypertension management in a teaching institution. [2007]