- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02665611
Remote Monitoring and Support for Patients With Schizophrenia, Schizoaffective or Bipolar Disorder on Adherence
The Effect of Remote Monitoring and Support for Patients Suffering From Schizophrenia, Schizoaffective or Bipolar Disorder on Adherence to Treatment
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
"Moma" call center is a result of collaboration between Maccabi Health Services and The Gertner Institute of Epidemiology and Health Policy Research. The call center provides remote continuous monitoring and support for patients with chronic illnesses, and has been found useful for improvement in treatment adherence and other clinical measures in patients with diabetes and CHF.
The current project focuses on patients diagnosed with schizophrenia, schizoaffective disorder and bipolar disorder. Patients that suffer from these disorders are prone to low adherence and are at risk for discontinuation of treatment and frequent relapses.
The advantages of the "Moma" call-center include high availability, reaching out, collaboration between treatment centers and agents, and continuous remote monitoring. We hypothesize that these factors will enable improvement of support provided to these patients, early detection of their needs, connection with community care agents, monitoring of treatment adherence, and remote interventions targeted towards prevention of relapse.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
Men & women,
- age 18-60 ,
- "Maccabi Health service" patients with diagnosis of: schizophrenia, Schizo - effective or Bipolar Dis.
- Must have 30 days or more of hospitalization (during 3 years). Treated with psychiatric medication.
- Living independently or with a help of a caregiver.
- Is able to provide written informed consent.
Exclusion Criteria:
- Violent, or suicidal.
- Drug\ Alcohol, addiction,
- End stage Disease (Cancer, ESRF act.)
- Non - in depended and without Care giver/legal guardian
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: intervention group
intervention for improvement of treatment adherence "Intervention group"- This group will be followed by the "MOMA" call center (By the MOMA nures every couple weeks and by the study coordinatore and the treating Doctor at special "visits" as the study required.)
The group will be monitored according to number of parameters, including treatment Adherence.
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intervention for improvement of adherence
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Expérimental: control group
treatment as usual Control group- Treatment will continue as usual by the Doctor.(This group will allso be followed by the Study Coordinator at the same "visits" as the "Intervention group".The group will be monitored according to number of parameters, including treatment Adherence.
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The control group will be treated according to the usual stadard of care.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
number of days of hospitalization
Délai: through study competion ,an average of 1 year.
|
through study competion ,an average of 1 year.
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Asaf B Caspi, MD, Sheba Medical Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2124-15-SMC
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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