Measuring the Effect of Remote Monitoring of Treatment Adherence on the Risk of Re-admission of Ambulatory Schizophrenic Patients
The Effect of add-on Tele Medicine Monitoring of Medication Adherence, on the Risk of Re-hospitalisation of Ambulatory Schizophrenic Patients. an Open, Prospective, Randomised Controled Trial
1 other identifier
interventional
200
1 country
1
Brief Summary
Schizophrenia is a chronic debilitating mental disorder, characterised by a relapsing remitting course. Although anti-psychotics can prevent relapse, its effect on schizophrenia outcome remains very limited, mainly due to very poor adherence to medications by the patients. This study aims to find, whether the add-on of remote monitoring of medication compliance via tele-medicine, to routine out-patient clinic care, can improve patients adherence and reduce the risk of relapse.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable schizophrenia
Started Jan 2014
Shorter than P25 for not_applicable schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2012
CompletedFirst Posted
Study publicly available on registry
November 20, 2012
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedApril 25, 2014
April 1, 2014
1.6 years
November 14, 2012
April 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to re-hospitalisation
Time to re-hospitalisation will be compared in the study group and in the control group during the follow-up period of up to one year
1 year
Secondary Outcomes (1)
number of re-hospitalisations
1 year
Other Outcomes (1)
Total time in hospital
1 year
Study Arms (2)
Experimental: Tele-medicine monitoring
EXPERIMENTALTele-medicine monitoring of medication adherence will be given to the study group as an add-on to routine out-patient treatment
No Intervention: Control Rutine out-patient treatment
NO INTERVENTIONroutine out-patient treatment will be given to the control group
Interventions
Eligibility Criteria
You may qualify if:
- DSM 4 diagnosis of schizophrenia or schizoaffective
- able to give written informed consent
- Have a telephone line
You may not qualify if:
- Are not discharged to a place with routine medication monitoring
- Are not discharged under forced ambulatory treatment order
- Are not homeless
- Are not admitted due to drug intoxication or withdrawal.
- Are not admitted due to severe self harm.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shalvata Mental Health Centerlead
- SHL Telemedicine Ltd.collaborator
Study Sites (1)
Shalvata MHC
Hod HaSharon, 45100, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2012
First Posted
November 20, 2012
Study Start
January 1, 2014
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
April 25, 2014
Record last verified: 2014-04