NCT05138601

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
7mo left

Started Nov 2021

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Nov 2021Dec 2026

First Submitted

Initial submission to the registry

September 22, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

November 16, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 1, 2021

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

July 11, 2025

Status Verified

July 1, 2025

Enrollment Period

4.9 years

First QC Date

September 22, 2021

Last Update Submit

July 8, 2025

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Systolic Blood Pressure (SBP) Control At 24 Months

    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 data model table for final analysis. Investigators will utilize the Benjamini-Hochberg approach to control for multiple testing in our primary outcome.

    24 months.

Secondary Outcomes (16)

  • Cognitive Measures

    0 months, 12 months, and 24 months

  • Major Adverse Cardiovascular Events (MACE)

    24 months

  • Atherosclerotic Cardiovascular Disease Risk (ASCVD)

    24 months

  • Health Care Resource Utilization: Charges Per Patient

    2 years

  • Mortality

    2 years

  • +11 more secondary outcomes

Study Arms (2)

Usual Care with Education

NO 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)

Virtual Collaborative Care Clinic

EXPERIMENTAL

Participants will partake in the virtual collaborative care clinic

Other: Virtual Collaborative Care Clinic

Interventions

Virtual Collaborative Care ClinicOTHER

Trained clinical pharmacists will monitor BP, prescribe and adjust medications and monitor for side effects of medications under the license of, and in communication with, the patient's physician.

Virtual Collaborative Care Clinic

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 65 and older
  • Active patient in participating primary care clinic
  • Access to compatible "smartphone" or device (i.e., Android, Kindle or Apple with internet connectivity or mobile network)
  • Elevated BP as defined by
  • SBP \>140 at current visit AND documented history of hypertension OR SBP \> 140 at current visit and at another visit in last 18 months OR SBP \>160 at current visit
  • Sufficiently fluent in English to participate in study procedures
  • Adequate hearing to complete study procedures
  • Able to give their own signed consent
  • Health insurance coverage by Medicare

You may not qualify if:

  • Clinically significant illness that may affect safety or completion per their treating PCP or study physician
  • Needing interpreter for clinic visits (through Electronic Health Record)
  • Currently in hospice care
  • Currently receiving chemotherapy
  • Unable to take accurate BP measurement, either due to inability to follow protocol to check BP or due to medical conditions such as lymphedema or dialysis access on both arms.
  • Currently participating in another intervention trial
  • End stage kidney disease on dialysis
  • Diagnosis of dementia (i.e., dementia, Alzheimer's disease, vascular dementia, dementia with Lewy bodies, frontotemporal dementia)
  • Chronic active disease with expected life expectancy \< 2 years as determined by the study team

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Kansas Health System

Kansas City, Kansas, 66160, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Jeffrey Burns, MD, MS

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2021

First Posted

December 1, 2021

Study Start

November 16, 2021

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

July 11, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)