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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01729572
• Other study ID #: 0004-12-SHA
• Status: Recruiting
• Phase: N/A
• First received: November 14, 2012
• Last updated: April 24, 2014
• Start date: January 2014
• Est. completion date: August 2015

Study information

• Verified date: April 2014
• Source: Shalvata Mental Health Center
• Contact: Israel Krieger, Dr. Med
• Phone: +97297478665
• Email: israelkr[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Other:
• Tele-medicine monitoring of medication adherence

Locations

Country	Name	City	State
Israel	Shalvata MHC	Hod-Hasharon

Sponsors (2)

Lead Sponsor	Collaborator
Shalvata Mental Health Center	SHL Telemedicine Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total time in hospital	Total time in hospital during the 1 year follow-up period will be compared between the study and the control groups.	1 year	No
Primary	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	No
Secondary	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	No