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Surveillance à distance et soins collaboratifs virtuels pour le contrôle de l'hypertension afin de prévenir le déclin cognitif Phase II (vCCC 2)

6 novembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

1000

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Kansas
      • Kansas City, Kansas, États-Unis, 66160
        • University of Kansas Health System
    • Utah
      • Salt Lake City, Utah, États-Unis, 84112
        • University of Utah

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

65 ans et plus (Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: 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)

Expérimental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Systolic Blood Pressure (SBP) Control At 24 Months
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Cognitive Measures
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

16 novembre 2021

Achèvement primaire (Réel)

8 septembre 2026

Achèvement de l'étude (Estimé)

31 juillet 2027

Dates d'inscription aux études

Première soumission

22 septembre 2021

Première soumission répondant aux critères de contrôle qualité

16 novembre 2021

Première publication (Réel)

1 décembre 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 00147392

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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