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Active, not recruitingNCT05138601ClinicalTrials.gov record

Remote Monitoring and Virtual Collaborative Care For Hypertension Control to Prevent Cognitive Decline Phase II

Hypertension

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Interventional
Phase
Not applicable
Age range
65 years - Not specified
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
1000 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the full description

This study 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 (University of Kansas Health System \[UKHS\] and the University of Utah Health \[UUtah\]). The vCCC is staffed by clinical pharmacists who remotely monitor home BP and use telehealth to work with patients to lower systolic blood pressure (SBP) to \<130 mmHg, as recommended by the current American College of Cardiology/American Heart Association (ACC/AHA) guidelines. Eligible patients with uncontrolled hypertension (HTN) are identified automatically through the electronic health record (EHR) during visits to their Primary Care Provider (PCP) and referred for enrollment into the vCCC.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Random assignment
Masking
Double masked
Usual Care with Education

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

Participants will partake in the virtual collaborative care clinic

Other: Virtual Collaborative Care Clinic

Virtual Collaborative Care Clinic OTHER

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.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Systolic Blood Pressure (SBP) Control At 24 Months

Time frame: 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.

Secondary measures

Cognitive Measures

Time frame: 0 months, 12 months, and 24 months

Investigators will use composite z score obtained by averaging standardized z scores of individual NP test scores and use z scores of individual tests to determine changes in a single test that may be obscured with the measurement of a global score. The tests are Montreal Cognitive Assessment (MoCA) Blind, Rey Auditory Verbal Learning Test (RAVLT), Number Span Forwards and Backwards (NSFB), Oral Trail Making Test (OTMT), Category Fluency, Verbal Fluency, Rey Auditory Verbal Naming Test Delayed Recall and Recognition, and Verbal Naming Test (VNT). MoCA Blind has 22 possible points, with19 or above normal. NSFB gives 2 scores, total number of correct trials and longest sequence repeated correctly with higher score indicating better working memory. The category fluency has 2 possible scores with a higher number of unique names indicating a better semantic memory. For the Verbal Fluency test the score reflects the number of unique responses with a higher score indicating better memory

Major Adverse Cardiovascular Events (MACE)

Time frame: 24 months

Data from the electronic health record (EHR) will be extracted. MACE will be identified by will be identified by International Statistical Classification of Diseases and Related Health Problems (ICD) and Current Procedural Terminology (CPT) codes for hospitalization due to myocardial infarction (MI), nonfatal stroke, coronary revascularization, and heart failure, which will be identified by combining observations from EHR

Atherosclerotic Cardiovascular Disease Risk (ASCVD)

Time frame: 24 months

Data from the EHR will be extracted. (ASCVD) score will be estimated by age, sex, race, BP, total cholesterol, HDL cholesterol, history of diabetes, smoking status, HTN treatment, statin and aspirin therapy. ASCVD score is given as a percentage. A 0 to 4.9% risk is considered low risk, 5 to 7.4% is considered borderline, a 7.5 to 20% risk is considered intermediate, and a score above 20% is considered high.

Health Care Resource Utilization: Charges Per Patient

Time frame: 2 years

Health utilization outcome measurement will be ascertained mainly by CMS claims data. The utilization outcome measurement will include charges per patient (measured as total and average dollar amount of charges).

Mortality

Time frame: 2 years

All-cause mortality, as a composite endpoint, will be obtained from Common Data Model DEATH table and be ascertained by linked Medicare Beneficiary Summary File available from Centers for Medicare and Medicaid Services (CMS)

Systolic Blood Pressure (SBP) Control At 12 Months

Time frame: 12 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.

Health utilization outcome measurement: Carrier Claims

Time frame: 2 years

Health utilization outcome measurement will be ascertained mainly by CMS claims data. The utilization outcome measurement will include healthcare-facility-metrics, such as carrier (physician Part B) claims (measured as total and average counts of distinct claims)

Health utilization outcome measurement: facility claims

Time frame: 2 years

Health utilization outcome measurement will be ascertained mainly by CMS claims data. The utilization outcome measurement will include outpatient, inpatient, skilled nursing facility claims (measured as total and average counts of distinct claims).

Health utilization outcome measurement: coronary care claims

Time frame: 2 years

Health utilization outcome measurement will be ascertained mainly by CMS claims data. The utilization outcome measurement will include component-of-care metrics, such as coronary care claims (measured as total and average counts of distinct claims)

Health utilization outcome measurement: coronary care expenditures

Time frame: 2 years

Health utilization outcome measurement will be ascertained mainly by CMS claims data. The utilization outcome measurement will include component-of-care metrics, such as coronary care expenditures (measured as total and average dollar amount of charges) per patient

Health utilization outcome measurement: coronary care unit days

Time frame: 2 years

Health utilization outcome measurement will be ascertained mainly by CMS claims data. The utilization outcome measurement will include component-of-care metrics, such as coronary care unit days (measured as total length of stay in coronary care unit).

Health utilization outcome measurement: intensive care unit (ICU) days

Time frame: 2 years

Health utilization outcome measurement will be ascertained mainly by CMS claims data. The utilization outcome measurement will include component-of-care metrics, such as ICU days (measured as total length of ICU stay) per patient.

Health utilization outcome measurement: general drug claims

Time frame: 2 years

Health utilization outcome measurement will be ascertained mainly by CMS claims data. The utilization outcome measurement will include component-of-care metrics such as general drugs and/or IV therapy claims (measured as total and average counts of distinct claims) per patient.

Health utilization outcome measurement: durable medical equipment Medicare payments

Time frame: 2 years

Health utilization outcome measurement will be ascertained mainly by CMS claims data. The utilization outcome measurement will include component-of-care metrics such as durable medical equipment Medicare payments (measured as total and average dollar amount of charges) per patient.

Health utilization outcome measurement: imaging and laboratory events

Time frame: 2 years

Health utilization outcome measurement will be ascertained mainly by CMS claims data. The utilization outcome measurement will include component-of-care metrics such as imaging and laboratory events (measured as total and average counts of distinct claims suggesting imaging and laboratory events).

Health utilization outcome measurement: imaging and laboratory expenditures

Time frame: 2 years

Health utilization outcome measurement will be ascertained mainly by CMS claims data. The utilization outcome measurement will include component-of-care metrics such as imaging and laboratory expenditures (measured as total and average dollar amount of charges) per patient.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (2)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

2 locations

University of Kansas Health SystemKansas City, Kansas, United StatesStatus unknown
University of UtahSalt Lake City, Utah, United StatesStatus unknown

Study team and timeline

Lead sponsor
University of Kansas Medical Center
Study start
Nov 16, 2021 Actual
Primary completion
Sep 8, 2026 Actual
Study completion
Jul 31, 2027 Estimated
First posted
Dec 1, 2021 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.

Official study title

Remote Monitoring and Virtual Collaborative Care For Hypertension Control to Prevent Cognitive Decline Phase II

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026