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

Shalvata Mental Health Center

Status: Unknown

Conditions: Schizophrenia; Schizoaffective Disorder

Treatments: Other: Tele-medicine monitoring of medication adherence

Study type: Interventional

Funder types: Other

Identifiers

NCT01729572

0004-12-SHA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Experimental: Tele-medicine monitoring

Experimental group

Description:

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

Treatment:

Other: Tele-medicine monitoring of medication adherence

No Intervention: Control Rutine out-patient treatment

No Intervention group

Description:

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