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

April 24, 2014 updated by: Shalvata Mental Health Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Hod-Hasharon, Israel, 45100
        • Recruiting
        • Shalvata MHC
        • Contact:
        • Principal Investigator:
          • Israel Krieger, Dr' Med

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
Other: Tele-medicine monitoring of medication adherence
NO_INTERVENTION: No Intervention: Control Rutine out-patient treatment
routine out-patient treatment will be given to the control group

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total time in hospital
Time Frame: 1 year
Total time in hospital during the 1 year follow-up period will be compared between the study and the control groups.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shalvata Mental Health Center

Collaborators

SHL Telemedicine Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (ANTICIPATED)

August 1, 2015

Study Completion (ANTICIPATED)

August 1, 2015

Study Registration Dates

First Submitted

November 14, 2012

First Submitted That Met QC Criteria

November 19, 2012

First Posted (ESTIMATE)

November 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 25, 2014

Last Update Submitted That Met QC Criteria

April 24, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0004-12-SHA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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