- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00778986
Effects of Remote Patient Monitoring on Heart Failure Management
Effects of Remote Patient Monitoring on Heart Failure Management: A Randomized Controlled Trial
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Poor management of heart failure (HF) has added to the high costs and negative health outcomes from this chronic illness, including frequent hospitalization. HF patients require close monitoring to detect worsening health and to optimize their treatment. However, many patients visit their HF clinicians only once every few months, and perform minimal or no self-monitoring.
Remote patient monitoring is a potential tool to help clinicians and the patients better manage HF. A remote patient monitoring system (home monitoring of vital signs and symptoms) that has been developed with extensive clinician and patient input and testing, will be studied to determine its effects on HF management. Half of one hundred patients from the University Health Network Heart Failure Clinic will be randomly placed into the remote monitoring (RM) group and the other half will be in the control group. Patients in the RM group will monitor their weight, blood pressure, ECG, and symptoms at home for 6 months. This information will be automatically sent from the medical devices wirelessly through Bluetooth to a mobile phone, which will send the information to the data servers. Both clinicians and patients will have access to the data. Patients will get automated reminder telephone calls if they do not take the number of measurements prescribed by their doctors.
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Ontario
-
Toronto, Ontario, Kanada, M5G 2C4
- University Health Network
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Clinical diagnosis of Heart Failure (NYHA Class II-IV)
- Out-patients attending the University Health Network Heart Failure Clinic
- English-speaking and able to read English
- 18 years old or over
Exclusion Criteria:
- Awaiting heart transplantation
- Not expected to survive over a year (as determined by their cardiologist)
- Unable to read text on a mobile phone due to vision disability
- Unable to self-care due to anxiety, depression, or decreased cognitive function
- Lack of manual dexterity to accurately press buttons on the mobile phone
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: remote monitoring
group of patients that will be using the heart failure remote patient monitoring system in addition to the usual care they receive at the University Health Network Heart Failure Clinic
|
remote monitoring of weight, blood pressure, ECG, and symptoms
|
|
Kein Eingriff: control
group of patients provided with usual care at the University Health Network Heart Failure Clinic
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Brain Natriuretic Peptide values
Zeitfenster: Baseline, 6 months
|
Baseline, 6 months
|
|
Self-care practices measured through Self-Care of Heart Failure Index scores and interviews
Zeitfenster: baseline, 6 months
|
baseline, 6 months
|
|
Health related quality of life measured through the Minnesota Living with Heart Failure Questionnaire scores and interviews
Zeitfenster: baseline, 6 months
|
baseline, 6 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Number of hospitalizations and days in hospital
Zeitfenster: 6 months comparison between intervention and control groups
|
6 months comparison between intervention and control groups
|
|
Number of Emergency Department visits
Zeitfenster: 6 month comparison between intervention and control groups
|
6 month comparison between intervention and control groups
|
|
All cause mortality
Zeitfenster: 6 month comparison between intervention and control groups
|
6 month comparison between intervention and control groups
|
|
Number of Heart Failure Clinic visits
Zeitfenster: 6 month comparison between intervention and control groups
|
6 month comparison between intervention and control groups
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Heather J Ross, MD, MHSc, University Health Network, Toronto
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Seto E, Leonard KJ, Cafazzo JA, Barnsley J, Masino C, Ross HJ. Developing healthcare rule-based expert systems: case study of a heart failure telemonitoring system. Int J Med Inform. 2012 Aug;81(8):556-65. doi: 10.1016/j.ijmedinf.2012.03.001. Epub 2012 Mar 31.
- Seto E, Leonard KJ, Cafazzo JA, Barnsley J, Masino C, Ross HJ. Mobile phone-based telemonitoring for heart failure management: a randomized controlled trial. J Med Internet Res. 2012 Feb 16;14(1):e31. doi: 10.2196/jmir.1909.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- HF-RPM-UHN
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