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

Study Overview
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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.

Official Title
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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

Conditions
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Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
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* Other: Tele-medicine monitoring of medication adherence


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Tele-medicine monitoring<br>Tele-medicine monitoring of medication adherence will be given to the study group as an add-on to routine out-patient treatment | Other: Tele-medicine monitoring of medication adherence<br> <br> |
| No Intervention: No Intervention: Control Rutine out-patient treatment<br>routine out-patient treatment will be given to the control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of re-hospitalisations | number of re-hospitalisations will be compared among the study and the control groups during the 1 year follow-up. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, Schizoaffective Disorder, disease management, treatment, rehabilitation, pharmacotherapy