- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00778986
Effects of Remote Patient Monitoring on Heart Failure Management
Effects of Remote Patient Monitoring on Heart Failure Management: A Randomized Controlled Trial
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Ontario
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Toronto, Ontario, Canada, M5G 2C4
- University Health Network
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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
|
|
Nessun intervento: control
group of patients provided with usual care at the University Health Network Heart Failure Clinic
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Brain Natriuretic Peptide values
Lasso di tempo: Baseline, 6 months
|
Baseline, 6 months
|
|
Self-care practices measured through Self-Care of Heart Failure Index scores and interviews
Lasso di tempo: baseline, 6 months
|
baseline, 6 months
|
|
Health related quality of life measured through the Minnesota Living with Heart Failure Questionnaire scores and interviews
Lasso di tempo: baseline, 6 months
|
baseline, 6 months
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Number of hospitalizations and days in hospital
Lasso di tempo: 6 months comparison between intervention and control groups
|
6 months comparison between intervention and control groups
|
|
Number of Emergency Department visits
Lasso di tempo: 6 month comparison between intervention and control groups
|
6 month comparison between intervention and control groups
|
|
All cause mortality
Lasso di tempo: 6 month comparison between intervention and control groups
|
6 month comparison between intervention and control groups
|
|
Number of Heart Failure Clinic visits
Lasso di tempo: 6 month comparison between intervention and control groups
|
6 month comparison between intervention and control groups
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Heather J Ross, MD, MHSc, University Health Network, Toronto
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- HF-RPM-UHN
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .