Remote Monitoring and Telehealth for High Blood Pressure

(vCCC 2 Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a virtual care program can help manage high blood pressure through telehealth and remote monitoring. Participants will either continue with their usual care and receive educational materials or join a Virtual Collaborative Care Clinic for additional support. The trial seeks individuals aged 65 and older with high blood pressure who regularly visit certain clinics and have access to a smartphone or similar device. As an unphased trial, it offers a unique opportunity to contribute to innovative healthcare solutions and potentially enhance personal health management.

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 prior data suggests that this hypertension program is safe?

Research shows that the virtual Collaborative Care Clinic (vCCC) effectively manages high blood pressure. Studies have found this method safe and easy to use. It involves meeting with healthcare providers online and checking blood pressure at home. Participants in these studies found it acceptable and helpful. No reports of serious side effects or issues have emerged with using the virtual clinic. This suggests that joining the vCCC for blood pressure control is a safe choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using a Virtual Collaborative Care Clinic for managing high blood pressure because it leverages technology to offer a more personalized and accessible approach to care. Unlike the standard practice, which often involves in-person visits and less frequent monitoring, this virtual clinic allows for continuous remote monitoring and real-time support from pharmacists via telehealth. This method could lead to better blood pressure management by providing timely interventions and support, potentially improving patient outcomes and convenience.

What evidence suggests that the Virtual Collaborative Care Clinic is effective for lowering high blood pressure?

Research has shown that virtual collaborative care clinics (vCCCs), which participants in this trial may experience, can help lower high blood pressure. One study demonstrated that remote patient monitoring and doctor care successfully reduced blood pressure measured at the doctor's office. Another study found that using a vCCC with home blood pressure checks and online doctor visits improved blood pressure control, with many patients maintaining their top blood pressure number below 130 mmHg. Overall, vCCCs appear promising for effectively managing high blood pressure. ^{1 3 6 7 8}

Who Is on the Research Team?

Jeffrey Burns

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

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

Needing interpreter for clinic visits (through Electronic Health Record)

Currently participating in another intervention trial

I am on dialysis for end-stage kidney disease.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05138601

Remote Monitoring and Virtual Collaborative Care For ... Our primary outcome is achieving SBP control (<130 mmHg). Blood pressure measures will be collected in a dashboard system and will be integrated into the common ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10563450/

Remote Patient Monitoring for Hypertension: Feasibility ... Randomized clinical trial to assess the effectiveness of remote patient monitoring and physician care in reducing office blood pressure.

3. trialx.com trialx.com/clinical-trials/listings/246112/remote-monitoring-and-virtual-collaborative-care-for-hypertension-control-to-prevent-cognitive-decline-phase-ii/

Remote Monitoring and Virtual Collaborative Care For ... This study tests a hypertension program integrating a virtual Collaborative Care Clinic (vCCC), home blood pressure monitoring, and telehealth for lowering ...

4. withpower.com withpower.com/trial/phase-hypertension-10-2021-d5c7f

Remote Monitoring and Telehealth for High Blood ... Trial Overview The trial tests a virtual hypertension management program combining home blood pressure monitoring and telehealth to lower blood pressure.

5. nature.com nature.com/articles/s41371-023-00850-w

Blood pressure outcomes at 12 months in primary care ... Outcomes at 3, 6, 9 and 12 months were: controlling high BP (most recent BP < 140/90 mm Hg), antihypertensive medication intensification, and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10047620/

Implementing a home-based virtual hypertension ... The virtual collaborative care clinic is safe and feasible and acceptable to stakeholders. Introduction. Hypertension affects 1 in 3 US adults.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12418473/

Clinical and Engagement Results of a Nationwide ... A nationwide RPC hypertension program can drive high patient engagement and facilitate clinical encounters at scale, resulting in reduced BP ...

8. ama-assn.org ama-assn.org/public-health/prevention-wellness/clinical-case-study-telehealth-hypertension

Clinical Case Study: Telehealth for Hypertension The virtual session provides an overview of techniques for managing hypertension via telehealth and remote patient monitoring.