Remote Monitoring and Virtual Collaborative Care For Hypertension Control To Prevent Cognitive Decline (vCCC)
7. Juli 2021 aktualisiert von: Jeff Burns, MD, University of Kansas Medical Center
Remote Monitoring and Virtual Collaborative Care For Hypertension Control To Prevent Cognitive Decline: Phase I
This purpose of this study is to examine an aggressive method of blood pressure control that involves home blood pressure monitoring and management of medications by a team of clinical pharmacists in coordination with a primary care physician.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
33
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Kansas
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Kansas City, Kansas, Vereinigte Staaten, 66106
- University of Kansas Medical Center
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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)
- Elevated blood pressure as defined by:
Systolic Blood Pressure >140 at current visit AND documented history of hypertension OR Systolic Blood Pressure > 140 at current visit and at another visit in last 18 months OR Systolic Blood Pressure >160 at current visit
- Sufficiently fluent in English to participate in study procedures
- Adequate vision and hearing to complete study procedures
Exclusion Criteria:
- Clinically significant illness that may affect safety or completion per their treating Primary Care Physician or study physician
- End stage renal disease on dialysis
- 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 |
|---|---|
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Experimental: Virtual Collaborative Care Clinic
The Virtual Collaborative Care Clinic arm participants use a home blood pressure monitor and routine blood pressure measurements will be uploaded to a dashboard monitored by clinical pharmacists.
Blood pressure will be managed aggressively by the clinical pharmacists in coordination with Primary Care Physicians.
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The vCCC will operate under a collaborative care agreement with the Primary Care Physicians as an extension (and not a replacement) of their care.
Trained clinical pharmacists will monitor blood pressure and prescribe and adjust medications under the license of, and in communication with, the patient's Primary Care Physician.
As part of the Primary Care Physician's team and per Primary Care Physician's directions, the pharmacists may coordinate blood pressure management with other clinicians such as cardiologists or nephrologists co-managing patients blood pressure.
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Kein Eingriff: Control Intervention
The control intervention will consist of providing the participant with educational material and a home blood pressure monitor.
The patients in the control group will not have support from Virtual Collaborative Care Clinic pharmacists.
Routine blood pressure measures using their device will not be collected via the dashboard and will not be available for pharmacist review.
Participants will continue to see their physicians for their usual care for blood pressure management.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Feasibility of system wide adoptability as assessed by survey responses
Zeitfenster: Baseline
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Primary Care Physicians and vCCC Pharmacists will be asked for feedback on feasibility of implementation via a survey.
The vCCC pharmacists and PCPs will be surveyed to assess feasibility and changing views of feasibility.
Brief, validated scales will be delivered via email (REDCap surveys) to assess the construct of feasibility.
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Baseline
|
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Feasibility of system wide adoptability as assessed by survey responses
Zeitfenster: 3 Months Post Baseline
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Primary Care Physicians and vCCC Pharmacists will be asked for feedback on feasibility of implementation via a survey.
The vCCC pharmacists and PCPs will be surveyed to assess feasibility and changing views of feasibility.
Brief, validated scales will be delivered via email (REDCap surveys) to assess the construct of feasibility.
|
3 Months Post Baseline
|
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Feasibility of system wide adoptability as assessed by Physician Advisory Board meetings discussion
Zeitfenster: Through study completion, an average of 9 months
|
Members of the Physician Advisory Board will be asked for feedback on system wide adoptability during the monthly Physician Advisory Board meetings.
The meetings will be recorded and summarized.
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Through study completion, an average of 9 months
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Feasibility of system wide adoptability as assessed by vCCC Pharmacist Interviews
Zeitfenster: Up to 2 months Post Baseline
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Virtual Collaborative Care Clinic Pharmacists will be asked for feedback on feasibility of system wide adoption.
We will conduct one-time semi-structured qualitative interviews with the Virtual Collaborative Care Clinic pharmacists.
The Virtual Collaborative Care Clinic pharmacist will be interviewed to assess implementation factors including the auto-referral process and open-ended questions on the process and suggestions for improvement.
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Up to 2 months Post Baseline
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Replicability to other health systems as assessed by survey responses
Zeitfenster: Baseline
|
Primary Care Physicians and vCCC Pharmacists will be asked for feedback on replicability to other health systems via a survey.
Brief, validated scales will be delivered via email (REDCap surveys) to assess the construct of replicability to other health systems.
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Baseline
|
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Replicability to other health systems as assessed by survey responses
Zeitfenster: 3 Months Post Baseline
|
Primary Care Physicians and vCCC Pharmacists will be asked for feedback on replicability to other health systems via a survey.
Brief, validated scales will be delivered via email (REDCap surveys) to assess the construct of replicability to other health systems.
|
3 Months Post Baseline
|
|
Replicability to other health systems as assessed by Physician Advisory Board meetings discussion
Zeitfenster: Through study completion, an average of 9 months
|
Members of the Physician Advisory Board will be asked for feedback on replicability to other health systems during the monthly Physician Advisory Board meetings.
The meetings will be recorded and summarized.
|
Through study completion, an average of 9 months
|
|
Replicability to other health systems as assessed by vCCC Pharmacist Interviews
Zeitfenster: Up to 2 months Post Baseline
|
vCCC Pharmacists will be asked for feedback on replicability to other health systems.
We will conduct one-time semi-structured qualitative interviews including open-ended questions.
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Up to 2 months Post Baseline
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Mitarbeiter
Ermittler
- Hauptermittler: Jeffrey Burns, MD, 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)
20. Oktober 2020
Primärer Abschluss (Tatsächlich)
2. Juli 2021
Studienabschluss (Tatsächlich)
2. Juli 2021
Studienanmeldedaten
Zuerst eingereicht
30. September 2020
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
9. Oktober 2020
Zuerst gepostet (Tatsächlich)
14. Oktober 2020
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
9. Juli 2021
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
7. Juli 2021
Zuletzt verifiziert
1. Juli 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- STUDY146086
- 1R61AG068483-01 (US NIH Stipendium/Vertrag)
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Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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