Measuring the Effect of Remote Monitoring of Treatment Adherence on the Risk of Re-admission of Ambulatory Schizophrenic Patients

Not Applicable

• Conditions: Schizophrenia; Schizoaffective Disorder
• Interventions: Other: Tele-medicine monitoring of medication adherence

• Registration Number: NCT01729572
• Lead Sponsor: Shalvata Mental Health Center

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.

Detailed Description

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. The study is an uni center, open, prospective, randomised and controlled.

Study Timeline

• Study First Submitted: 2012-11-14
• Study First Submitted QC: 2012-11-19
• Study First Posted: 2012-11-20
• Study Start: 2014-01
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-24
• Last Update Posted: 2014-04-25
• Primary Completion: 2015-08
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• DSM 4 diagnosis of schizophrenia or schizoaffective
• able to give written informed consent
• Have a telephone line

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Tele-medicine monitoring	Tele-medicine monitoring of medication adherence	Tele-medicine monitoring of medication adherence will be given to the study group as an add-on to routine out-patient treatment

Primary Outcome Measures

Name	Time	Method
Time to re-hospitalisation	1 year	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

Secondary Outcome Measures

Name	Time	Method
number of re-hospitalisations	1 year	number of re-hospitalisations will be compared among the study and the control groups during the 1 year follow-up.

Trial Locations

Locations (1)

Shalvata MHC; 🇮🇱 Hod-Hasharon, Israel