search
Back to results

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

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Tele-medicine monitoring of medication adherence
Sponsored by
Shalvata Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, Schizoaffective Disorder, disease management, treatment, rehabilitation, pharmacotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Shalvata MHCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental: Tele-medicine monitoring

No Intervention: Control Rutine out-patient treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 14, 2012
Last Updated
April 24, 2014
Sponsor
Shalvata Mental Health Center
Collaborators
SHL Telemedicine Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT01729572
Brief Title
Measuring the Effect of Remote Monitoring of Treatment Adherence on the Risk of Re-admission of Ambulatory Schizophrenic Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
August 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shalvata Mental Health Center
Collaborators
SHL Telemedicine Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
schizophrenia, Schizoaffective Disorder, disease management, treatment, rehabilitation, pharmacotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Tele-medicine monitoring
Arm Type
Experimental
Arm Description
Tele-medicine monitoring of medication adherence will be given to the study group as an add-on to routine out-patient treatment
Arm Title
No Intervention: Control Rutine out-patient treatment
Arm Type
No Intervention
Arm Description
routine out-patient treatment will be given to the control group
Intervention Type
Other
Intervention Name(s)
Tele-medicine monitoring of medication adherence
Primary Outcome Measure Information:
Title
Time to re-hospitalisation
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
number of re-hospitalisations
Description
number of re-hospitalisations will be compared among the study and the control groups during the 1 year follow-up.
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Total time in hospital
Description
Total time in hospital during the 1 year follow-up period will be compared between the study and the control groups.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Israel Krieger, Dr. Med
Phone
+97297478665
Email
israelkr@clalit.org.il
Facility Information:
Facility Name
Shalvata MHC
City
Hod-Hasharon
ZIP/Postal Code
45100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Israel Krieger, Dr' Med
Phone
+97297478665
Email
israelkr@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Israel Krieger, Dr' Med

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs