Remote Monitoring and Telehealth for High Blood Pressure

(vCCC 2 Trial)

Recruiting at 1 trial location

Overseen By Amber Wilson

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Dementia, Hospice, Chemotherapy, Dialysis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

1000 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a randomized, controlled, pragmatic trial designed as a "type I hybrid effectiveness-implementation trial" that tests a hypertension program integrating a virtual Collaborative Care Clinic (vCCC), home blood pressure monitoring, and telehealth for lowering blood pressure (BP) in two health systems.

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 study team or your doctor.

What data supports the effectiveness of the treatment Virtual Collaborative Care Clinic for high blood pressure?

Research shows that virtual management of high blood pressure, including telemonitoring (remote tracking) and telehealth (remote healthcare services), can improve blood pressure control by allowing for more frequent communication and personalized care. Studies have found that these methods help patients better manage their condition, leading to improved outcomes. ^{1 2 3 4 5}

Is remote monitoring and telehealth for high blood pressure safe for humans?

Research on remote monitoring and telehealth for high blood pressure, including programs like the Virtual Collaborative Care Clinic, suggests that these methods are generally safe for humans. Studies have shown that patients can accurately measure and transmit their blood pressure readings, and these systems have been used successfully without significant safety concerns. ^{1 6 7 8 9}

How is the Virtual Collaborative Care Clinic treatment for high blood pressure different from other treatments?

The Virtual Collaborative Care Clinic treatment for high blood pressure is unique because it uses remote monitoring and telehealth to manage the condition. This approach involves digitally transmitting home blood pressure readings and using algorithmic care pathways to help patients reach their blood pressure goals, which is different from traditional in-person visits and manual monitoring. ^{1 2 9 10 11}

Research Team

Jeffrey Burns

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

This trial is for people aged 65 and older with high blood pressure who can hear well, speak English, use a smartphone or similar device, and have Medicare. They must not be in hospice care, on dialysis for kidney failure, receiving chemotherapy or other trials' interventions, diagnosed with dementia or any severe illness that could interfere with the study.

Inclusion Criteria

Access to compatible "smartphone" or device (i.e., Android, Kindle or Apple with internet connectivity or mobile network)

I can hear well enough to follow study instructions.

I have high blood pressure with a reading over 140 or had a reading over 160.

Exclusion Criteria

Currently participating in another intervention trial

Needing interpreter for clinic visits (through Electronic Health Record)

I am on dialysis for end-stage kidney disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants partake in the virtual collaborative care clinic, including home blood pressure monitoring and telehealth consultations to manage hypertension

24 months

Regular virtual visits for monitoring and consultation

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on cognitive measures and health utilization outcomes

24 months

Treatment Details

Interventions

• Virtual Collaborative Care Clinic

Trial Overview The trial tests a virtual hypertension management program combining home blood pressure monitoring and telehealth to lower blood pressure. Participants are randomly assigned to either receive this new virtual Collaborative Care Clinic (vCCC) approach or continue their usual care.

Participant Groups

Group I: Virtual Collaborative Care Clinic Experimental Treatment 1 Intervention

Participants will partake in the virtual collaborative care clinic

Group II: Usual Care with Education Active Control 1 Intervention

The participant will be provided with educational material and a home BP monitor. Control participants will continue to see their physicians for their usual care for BP management (their BP data will not be reviewed by pharmacists and the patients will not have support from vCCC pharmacists)

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

University of Missouri-Columbia

Collaborator

Trials

387

Recruited

629,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Findings from Research

A study involving 236 hypertensive patients found that antihypertensive treatment guided by telemonitoring of home blood pressure was as effective as traditional office-based monitoring in reducing systolic daytime blood pressure over 6 months.

Both groups experienced significant decreases in blood pressure, with the telemonitoring group showing a reduction of -11.9 mmHg compared to -9.6 mmHg in the control group, indicating that home monitoring can be a viable alternative for managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood pressure control during telemonitoring of home blood pressure. A randomized controlled trial during 6 months. Madsen, LB., Kirkegaard, P., Pedersen, EB.[2008]

In a 12-month trial involving 120 older adults (average age 79.5 years), combining home blood pressure telemonitoring with pharmacist-led case management did not significantly improve the achievement of target ambulatory blood pressure levels compared to usual care.

However, the intervention did lead to significant reductions in home blood pressure readings, although it also resulted in a higher incidence of hypotension (systolic BP < 110) without causing major adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemonitoring and protocolized case management for hypertensive community dwelling older adults (TECHNOMED): a randomized controlled trial. Lau, D., Ringrose, J., McAlister, FA., et al.[2022]

Home blood pressure telemonitoring can significantly improve blood pressure control and reduce hypertension when combined with structured case management, but it is not widely adopted in Canada due to various barriers.

Key challenges to implementing home BP telemonitoring include the need for better infrastructure, user-friendly technology, data security, and appropriate reimbursement models for healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home Blood Pressure Telemonitoring: Rationale for Use, Required Elements, and Barriers to Implementation in Canada. Wood, PW., Boulanger, P., Padwal, RS.[2018]

The integration of Omron VitalSight remote physiologic monitoring (RPM) into electronic health records showed improved blood pressure control in patients with hypertension, with 31.4% of uncontrolled hypertension patients achieving control compared to 22.8% in matched controls after 6 months.

Despite low uptake of RPM among physicians (only 10 prescribing to 118 patients), the results suggest that RPM may enhance physician awareness and management of hypertension, indicating a potential benefit in patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote physiologic monitoring for hypertension in primary care: a prospective pragmatic pilot study in electronic health records using propensity score matching. Petito, LC., Anthony, L., Peprah, YA., et al.[2023]

A remote hypertension management program was developed that uses home blood pressure monitoring and algorithmic care pathways, showing promise in helping patients achieve better blood pressure control.

The program involves non-licensed patient navigators working under the supervision of healthcare professionals, allowing for personalized medication adjustments based on patient-specific characteristics, which could enhance scalability and effectiveness in managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A remote hypertension management program clinical algorithm. Nichols, H., Cannon, CP., Scirica, BM., et al.[2022]

A study involving 288 Medicare patients using remote patient monitoring (RPM) for hypertension showed significantly better blood pressure control at 3 and 12 months compared to 1152 matched controls, with 71.5% of RPM patients achieving BP control versus 58.1% in controls after 12 months.

RPM patients also had lower average systolic blood pressure (132.3 mm Hg) compared to controls (136.5 mm Hg) after 12 months, indicating that RPM can enhance hypertension management in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood pressure outcomes at 12 months in primary care patients prescribed remote physiological monitoring for hypertension: a prospective cohort study. Petito, LC., Anthony, L., Peprah, Y., et al.[2023]

References

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

Virtual management of hypertension: lessons from the COVID-19 pandemic-International Society of Hypertension position paper endorsed by the World Hypertension League and European Society of Hypertension. [2022]

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

Blood pressure control during telemonitoring of home blood pressure. A randomized controlled trial during 6 months. [2008]

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

New Concepts in Hypertension Management: A Population-Based Perspective. [2022]

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

Hypertension telemanagement in blacks. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Telemonitoring and protocolized case management for hypertensive community dwelling older adults (TECHNOMED): a randomized controlled trial. [2022]

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

Association of a Remote Blood Pressure Monitoring Program With Postpartum Adverse Outcomes. [2023]

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

Accuracy of blood pressure measurements transmitted through a telemedicine system in underserved populations. [2008]

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

Home Blood Pressure Telemonitoring: Rationale for Use, Required Elements, and Barriers to Implementation in Canada. [2018]

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

Remote physiologic monitoring for hypertension in primary care: a prospective pragmatic pilot study in electronic health records using propensity score matching. [2023]

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

A remote hypertension management program clinical algorithm. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Blood pressure outcomes at 12 months in primary care patients prescribed remote physiological monitoring for hypertension: a prospective cohort study. [2023]