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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01729572
Enrollment
200
Registered
2012-11-20
Start date
2014-01-31
Completion date
2015-08-31
Last updated
2014-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizoaffective Disorder, Schizophrenia

Keywords

schizophrenia, Schizoaffective Disorder, disease management, treatment, rehabilitation, pharmacotherapy

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.

Interventions

OTHERTele-medicine monitoring of medication adherence

Sponsors

SHL Telemedicine Ltd.
CollaboratorUNKNOWN
Shalvata Mental Health Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Time to re-hospitalisation1 yearTime 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

MeasureTime frameDescription
number of re-hospitalisations1 yearnumber of re-hospitalisations will be compared among the study and the control groups during the 1 year follow-up.

Other

MeasureTime frameDescription
Total time in hospital1 yearTotal time in hospital during the 1 year follow-up period will be compared between the study and the control groups.

Countries

Israel

Contacts

Primary ContactIsrael Krieger, Dr. Med
israelkr@clalit.org.il+97297478665

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026