- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00778986
Effects of Remote Patient Monitoring on Heart Failure Management
Effects of Remote Patient Monitoring on Heart Failure Management: A Randomized Controlled Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2C4
- University Health Network
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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
|
Aucune intervention: control
group of patients provided with usual care at the University Health Network Heart Failure Clinic
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Brain Natriuretic Peptide values
Délai: Baseline, 6 months
|
Baseline, 6 months
|
Self-care practices measured through Self-Care of Heart Failure Index scores and interviews
Délai: baseline, 6 months
|
baseline, 6 months
|
Health related quality of life measured through the Minnesota Living with Heart Failure Questionnaire scores and interviews
Délai: baseline, 6 months
|
baseline, 6 months
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Number of hospitalizations and days in hospital
Délai: 6 months comparison between intervention and control groups
|
6 months comparison between intervention and control groups
|
Number of Emergency Department visits
Délai: 6 month comparison between intervention and control groups
|
6 month comparison between intervention and control groups
|
All cause mortality
Délai: 6 month comparison between intervention and control groups
|
6 month comparison between intervention and control groups
|
Number of Heart Failure Clinic visits
Délai: 6 month comparison between intervention and control groups
|
6 month comparison between intervention and control groups
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Heather J Ross, MD, MHSc, University Health Network, Toronto
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HF-RPM-UHN
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Insuffisance cardiaque
-
Region SkaneInscription sur invitationInsuffisance cardiaque New York Heart Association (NYHA) Classe II | Insuffisance cardiaque Classe III de la New York Heart Association (NYHA)Suède
-
Medical University of BialystokInstitute of Cardiology, Warsaw, Poland; Medical University of Lodz; Poznan... et autres collaborateursPas encore de recrutementInsuffisance cardiaque, systolique | Insuffisance cardiaque avec fraction d'éjection réduite | Insuffisance cardiaque New York Heart Association Classe IV | Insuffisance cardiaque Classe III de la New York Heart AssociationPologne
-
University of WashingtonAmerican Heart AssociationComplétéInsuffisance cardiaque, congestive | Altération mitochondriale | Insuffisance cardiaque New York Heart Association Classe IVÉtats-Unis