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HypertensionvCCC 2NCT05138601

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

A study testing Virtual Collaborative Care Clinic in people with Hypertension, run by University of Kansas Medical Center at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Hypertension
What is being tested?
Virtual Collaborative Care Clinic
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
2 sitesUnited States
Study dates
16 Nov 2021to 31 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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
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  • Adequate hearing to complete study procedures
  • Able to give their own signed consent
  • Health insurance coverage by Medicare

Who cannot join

  • 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
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  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • University of Kansas Health System

    Kansas City, Kansas, 66160

  • University of Utah

    Salt Lake City, Utah, 84112

Other trials in United States

About this study

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 detailed 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.

Conditions
Hypertension
Being tested
Virtual Collaborative Care Clinic
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05138601
Study groupRoleWhat they receive
Usual Care with EducationNo interventionThe 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 ClinicExperimentalParticipants will partake in the virtual collaborative care clinic
Receives: Other: Virtual Collaborative Care Clinic

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 months.

Secondary outcomes (16)
  1. Cognitive Measures

    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

    Measured: 0 months, 12 months, and 24 months

  2. Major Adverse Cardiovascular Events (MACE)

    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

    Measured: 24 months

  3. Atherosclerotic Cardiovascular Disease Risk (ASCVD)

    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.

    Measured: 24 months

  4. Health Care Resource Utilization: Charges Per Patient

    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).

    Measured: 2 years

  5. Mortality

    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)

    Measured: 2 years

  6. Systolic Blood Pressure (SBP) Control At 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.

    Measured: 12 Months

  7. Health utilization outcome measurement: Carrier Claims

    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)

    Measured: 2 years

  8. Health utilization outcome measurement: facility claims

    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).

    Measured: 2 years

  9. Health utilization outcome measurement: coronary care claims

    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)

    Measured: 2 years

  10. Health utilization outcome measurement: coronary care expenditures

    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

    Measured: 2 years

  11. Health utilization outcome measurement: coronary care unit days

    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).

    Measured: 2 years

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

    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.

    Measured: 2 years

  13. Health utilization outcome measurement: general drug claims

    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.

    Measured: 2 years

  14. Health utilization outcome measurement: durable medical equipment Medicare payments

    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.

    Measured: 2 years

  15. Health utilization outcome measurement: imaging and laboratory events

    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).

    Measured: 2 years

  16. Health utilization outcome measurement: imaging and laboratory expenditures

    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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2021
  2. Study start16 Nov 2021
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
1,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05138601
Sponsor's protocol ID
00147392
Acronym
vCCC 2
Status last verified
Jun 2026
First submitted
22 Sep 2021
Last updated
26 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Collaborative Care Clinic in people with Hypertension, run by University of Kansas Medical Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Systolic Blood Pressure (SBP) Control At 24 Months (time frame: 24 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.

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