Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Mobile Cardiovascular Risk Service Trial (mCVRS)

9. Oktober 2018 aktualisiert von: Elizabeth A Chrischilles, University of Iowa

Design and Testing of a Mobile Cardiovascular Risk Service With Patient Partners

Risk factors for cardiovascular disease are poorly controlled even for patients who frequently visit their physician, leading to large numbers of preventable cardiovascular events such as heart attacks and strokes. Research from integrated healthcare systems suggests that risk factors can be controlled better and treatment strategies for cardiovascular disease can be markedly improved by using a centralized cardiovascular risk service (CVRS) managed by pharmacists. The investigators are confident that a pharmacist-managed mHealth CVRS can become a strategy in un-integrated healthcare settings to markedly reduce cardiovascular events in the United States.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Cardiovascular disease (CVD) causes 2,200 deaths in Americans every day with one death every 39 seconds. There is evidence that these deaths can be prevented with better risk factor management, however, many risk factors remain uncontrolled. The Patient-Centered Medical Home (Medical Home) which includes self-management, personalized health records and team-based care, has been proposed as a strategy to reduce these gaps in care delivery. Several Cochrane reviews and meta-analyses have found evidence that adding pharmacists to the primary care team improves risk factor control and physician adherence to guidelines. Managed care organizations have found that a centralized cardiovascular risk service (CVRS) managed by pharmacists can reduce mortality. A gap in the literature is that it is not known whether a comprehensive CVRS model would be implemented in typical office practices in un-integrated settings. Simultaneously, systematic reviews of mobile health (mHealth) trials including disease management apps have found no trial that has incorporated communication with a pharmacist and this lack of evidence is a major gap in the mHealth literature.

The objective of this application is to develop and test a mobile app enabled, pharmacist managed CVRS for disseminating and implementing evidence-based guidelines in practice. In addition to developing the app with patients as design partners, the investigators will conduct a multi-center individually randomized study nested within an ongoing NIH trial in medical offices with large geographic, racial and ethnic diversity. The study team will randomize 100 patients from primary care offices to mHealth CVRS (mobile app + web site + pharmacist) or to CVRS only (web site + pharmacist) of whom 55 will be from racial/ethnic minorities. The central hypothesis is that the mHealth CVRS designed with patients as partners will be implemented and significantly improve patient engagement, leading to improved CVD guideline adherence using the Get with The Guidelines and Guideline Advantage metrics. The rationale for this proposed study is that a novel mHealth model that improves secondary prevention of CVD with pharmacist assistance will lead to broader adoption by health systems throughout the US.

The primary Aim is: to examine the feasibility of mHealth technology to disseminate evidence-based risk reduction guidelines in a prospective randomized controlled trial among diverse primary care offices. The investigators postulate that system engagement (primary hypothesis) and adherence to guidelines for secondary prevention of CVD (secondary hypothesis) will be significantly greater in patients randomized to the mHealth intervention compared to the control group.

This study is expected to produce the following outcomes: unique mobile app features that complement the standard CVRS, increased engagement with a CVRS and increased achievement of guideline-concordant therapy.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

80

Phase

  • Unzutreffend

Kontakte und Standorte

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

Studienorte

  • Vereinigte Staaten
    • Iowa
      • Iowa City, Iowa, Vereinigte Staaten, 52242
        • University of Iowa
      • Sioux City, Iowa, Vereinigte Staaten, 51105
        • Siouxland Community Health Center

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

55 Jahre bis 99 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

INCLUSION CRITERIA:

  1. Patients age 55 and older;
  2. Owns and uses a smartphone;

  3. Any ONE of the following guideline-related needs in the past 18 months:

    1. Most recent encounter LDL >= 100 mg/dl
    2. Most recent encounter BP > 140/90 mmHg (or > 150/90 for persons age 60+)
    3. Most recent encounter not taking recommended post-stroke medications
    4. Most recent encounter not taking recommended post-MI medications
    5. Diabetics with most recent encounter not on ACE inhibitor or ARB blocker
    6. Any patient with most recent A1c > 8.0%
    7. Diabetics with no urine microalbumin screening, past 18 months

EXCLUSION CRITERIA:

  1. Non-English speaking (app available only in English for this study)
  2. No encounter in the past 18 months (they may be receiving care elsewhere and guideline-related needs may not be reliably assessed) at the clinic itself
  3. Most recent systolic BP >200 or diastolic BP > 110 mm Hg
  4. Any history of significant hepatic disease, including cirrhosis, Hepatitis B or C infection, or laboratory abnormalities (serum ALT or AST > 3 times normal (either AST above 96 U/L or ALT above 99 U/L or total bilirubin > 2.0 mg/dl))
  5. History of hemorrhagic stroke
  6. Pulmonary hypertension
  7. Stage 4 or metastatic cancer
  8. Current nursing home residence or has plans to move to one within the next 12 months
  9. Has plans to transfer care from the current clinic within the next 6 months
  10. Inability to give informed consent or impaired cognitive function
  11. Currently pregnant (females only)
  12. Currently a prisoner

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Web and mobile app access
Subjects will have access to both the mobile and web-app versions of the study Personal Health Record to communicate with the study pharmacist and enter and track their health data.
Sonstiges: Pharmacist-led cardiovascular risk service (CVRS)
CVRS pharmacists will access the study database including patient baseline information obtained from the medical record and patient entered data to make their assessments and recommendations to onsite physicians and onsite clinical pharmacists and individualize their communication with patients. The intervention will provide patient-centered counseling and education to improve medication adherence, lifestyle modifications and/or smoking cessation. The CVRS pharmacist does not make changes to therapy independently but, rather, provides the physicians and on-site pharmacists with action plans and status updates about adherence to Guideline metrics, which should markedly reduce the gaps in guideline-concordant therapy that place patients at risk for CVD events.
Sonstiges: Mobile access to study Personal Health Record
Only subjects assigned to the intervention arm will have access to the mobile app version of the study personal Health Record.
Sonstiges: Web access to study Personal Health Record
Subjects assigned to both the intervention and control arms will have access to the standard website version of the study personal Health Record.
Aktiver Komparator: Web app only access
Subjects will have access to the web-app version of the study Personal Health Record (and not the mobile app version) to communicate with the study pharmacist and enter and track their health data.
Sonstiges: Pharmacist-led cardiovascular risk service (CVRS)
CVRS pharmacists will access the study database including patient baseline information obtained from the medical record and patient entered data to make their assessments and recommendations to onsite physicians and onsite clinical pharmacists and individualize their communication with patients. The intervention will provide patient-centered counseling and education to improve medication adherence, lifestyle modifications and/or smoking cessation. The CVRS pharmacist does not make changes to therapy independently but, rather, provides the physicians and on-site pharmacists with action plans and status updates about adherence to Guideline metrics, which should markedly reduce the gaps in guideline-concordant therapy that place patients at risk for CVD events.
Sonstiges: Web access to study Personal Health Record
Subjects assigned to both the intervention and control arms will have access to the standard website version of the study personal Health Record.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mean number of days on which a patient interacts with the cardiovascular risk service (using either mobile app or web-site)
Zeitfenster: 4 months post enrollment
Mean number of days on which a patient interacts with the cardiovascular risk service (using either mobile app or web-site)
4 months post enrollment
Mean number of contacts with a pharmacist
Zeitfenster: 4 months post enrollment
Mean number of contacts with a pharmacist
4 months post enrollment

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Guideline Adherence score calculated on the subset of guidelines amenable to intervention during the 4 month intervention
Zeitfenster: 4 months post enrollment
Guideline Adherence score calculated on the subset of guidelines amenable to intervention during the 4 month intervention
4 months post enrollment

Mitarbeiter und Ermittler

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

Sponsor

University of Iowa

Ermittler

  • Hauptermittler: Elizabeth Chrischilles, PhD, University of Iowa

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)

1. September 2017

Primärer Abschluss (Tatsächlich)

31. August 2018

Studienabschluss (Tatsächlich)

31. August 2018

Studienanmeldedaten

Zuerst eingereicht

10. März 2017

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. März 2017

Zuerst gepostet (Tatsächlich)

16. März 2017

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. Oktober 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. Oktober 2018

Zuletzt verifiziert

1. Oktober 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 201603819

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Ja

Beschreibung des IPD-Plans

Public use data sets will be created and made available to other investigators in a timely manner. Data will only be provided in the form of fully HIPAA-de-identified datasets. Data sets will be carefully reviewed to make sure that information such as age and gender cannot be used to gather additional information that could potentially identify individual subjects. All categorical demographic variables will be collapsed into categories large enough so that combinations of demographic categories for age, gender or area of residence will have 10 or more individuals in each cell. The investigators plan to create SAS datasets in transport format and provide data dictionaries describing the contents of each dataset. Investigators requesting access to the data will be asked to complete a data sharing agreement.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Mongolia

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

Abonnieren