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Fernüberwachung und virtuelle kollaborative Pflege zur Kontrolle des Bluthochdrucks zur Verhinderung eines kognitiven Rückgangs, Phase II (vCCC 2)

6. November 2026 aktualisiert von: University of Kansas Medical Center

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.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

1000

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Kansas
      • Kansas City, Kansas, Vereinigte Staaten, 66160
        • University of Kansas Health System
    • Utah
      • Salt Lake City, Utah, Vereinigte Staaten, 84112
        • University of Utah

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

65 Jahre und älter (Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: 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)

Experimental: Virtual Collaborative Care Clinic

Participants will partake in the virtual collaborative care clinic

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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Systolic Blood Pressure (SBP) Control At 24 Months
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Cognitive Measures
Zeitfenster: 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

0 months, 12 months, and 24 months
Major Adverse Cardiovascular Events (MACE)
Zeitfenster: 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

24 months
Atherosclerotic Cardiovascular Disease Risk (ASCVD)
Zeitfenster: 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.

24 months
Health Care Resource Utilization: Charges Per Patient
Zeitfenster: 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).

2 years
Mortality
Zeitfenster: 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)

2 years
Systolic Blood Pressure (SBP) Control At 12 Months
Zeitfenster: 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.

12 Months
Health utilization outcome measurement: Carrier Claims
Zeitfenster: 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)

2 years
Health utilization outcome measurement: facility claims
Zeitfenster: 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).

2 years
Health utilization outcome measurement: coronary care claims
Zeitfenster: 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)

2 years
Health utilization outcome measurement: coronary care expenditures
Zeitfenster: 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

2 years
Health utilization outcome measurement: coronary care unit days
Zeitfenster: 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).

2 years
Health utilization outcome measurement: intensive care unit (ICU) days
Zeitfenster: 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.

2 years
Health utilization outcome measurement: general drug claims
Zeitfenster: 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.

2 years
Health utilization outcome measurement: durable medical equipment Medicare payments
Zeitfenster: 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.

2 years
Health utilization outcome measurement: imaging and laboratory events
Zeitfenster: 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).

2 years
Health utilization outcome measurement: imaging and laboratory expenditures
Zeitfenster: 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.

2 years

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Jeffrey Burns, MD, MS, University of Kansas Medical Center

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

16. November 2021

Primärer Abschluss (Tatsächlich)

8. September 2026

Studienabschluss (Geschätzt)

31. Juli 2027

Studienanmeldedaten

Zuerst eingereicht

22. September 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

16. November 2021

Zuerst gepostet (Tatsächlich)

1. Dezember 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. November 2026

Zuletzt verifiziert

1. November 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 00147392

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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