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

NCT ID: NCT01729572

Last Updated: 2014-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-08-31

Brief Summary

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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

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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.

Conditions

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Schizophrenia Schizoaffective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental: Tele-medicine monitoring

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

Group Type EXPERIMENTAL

Tele-medicine monitoring of medication adherence

Intervention Type OTHER

No Intervention: Control Rutine out-patient treatment

routine out-patient treatment will be given to the control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tele-medicine monitoring of medication adherence

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SHL Telemedicine Ltd.

UNKNOWN

Sponsor Role collaborator

Shalvata Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shalvata MHC

Hod HaSharon, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Israel Krieger, Dr. Med

Role: CONTACT

+97297478665

Facility Contacts

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Israel Krieger, Dr' Med

Role: primary

+97297478665

Other Identifiers

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0004-12-SHA

Identifier Type: -

Identifier Source: org_study_id

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