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Remote Monitoring and Support for Patients With Schizophrenia, Schizoaffective or Bipolar Disorder on Adherence

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Bipolar Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
intervention for improvement of adherence
treatment as usual
Sponsored by
Assuta Hospital Systems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Men & women,

  1. age 18-60 ,
  2. "Maccabi Health service" patients with diagnosis of: schizophrenia, Schizo - effective or Bipolar Dis.
  3. Must have 30 days or more of hospitalization (during 3 years). Treated with psychiatric medication.
  4. Living independently or with a help of a caregiver.
  5. Is able to provide written informed consent.

Exclusion Criteria:

  1. Violent, or suicidal.
  2. Drug\ Alcohol, addiction,
  3. End stage Disease (Cancer, ESRF act.)
  4. Non - in depended and without Care giver/legal guardian

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    intervention group

    control group

    Arm Description

    intervention for improvement of treatment adherence "Intervention group"- This group will be followed by the "MOMA" call center (By the MOMA nures every couple weeks and by the study coordinatore and the treating Doctor at special "visits" as the study required.) The group will be monitored according to number of parameters, including treatment Adherence.

    treatment as usual Control group- Treatment will continue as usual by the Doctor.(This group will allso be followed by the Study Coordinator at the same "visits" as the "Intervention group".The group will be monitored according to number of parameters, including treatment Adherence.

    Outcomes

    Primary Outcome Measures

    number of days of hospitalization

    Secondary Outcome Measures

    Full Information

    First Posted
    January 18, 2016
    Last Updated
    February 7, 2016
    Sponsor
    Assuta Hospital Systems
    Collaborators
    Sheba Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02665611
    Brief Title
    Remote Monitoring and Support for Patients With Schizophrenia, Schizoaffective or Bipolar Disorder on Adherence
    Official Title
    The Effect of Remote Monitoring and Support for Patients Suffering From Schizophrenia, Schizoaffective or Bipolar Disorder on Adherence to Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2016 (undefined)
    Primary Completion Date
    January 2018 (Anticipated)
    Study Completion Date
    January 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assuta Hospital Systems
    Collaborators
    Sheba Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Moma call center will provide unique service -Remote monitoring and support for mental health patients .The aim of this reserch is reducing hospitalization and improve adherence, by reaching out and there for monitoring very closely .
    Detailed Description
    "Moma" call center is a result of collaboration between Maccabi Health Services and The Gertner Institute of Epidemiology and Health Policy Research. The call center provides remote continuous monitoring and support for patients with chronic illnesses, and has been found useful for improvement in treatment adherence and other clinical measures in patients with diabetes and CHF. The current project focuses on patients diagnosed with schizophrenia, schizoaffective disorder and bipolar disorder. Patients that suffer from these disorders are prone to low adherence and are at risk for discontinuation of treatment and frequent relapses. The advantages of the "Moma" call-center include high availability, reaching out, collaboration between treatment centers and agents, and continuous remote monitoring. We hypothesize that these factors will enable improvement of support provided to these patients, early detection of their needs, connection with community care agents, monitoring of treatment adherence, and remote interventions targeted towards prevention of relapse.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia, Schizoaffective Disorder, Bipolar Disorder

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    intervention group
    Arm Type
    Experimental
    Arm Description
    intervention for improvement of treatment adherence "Intervention group"- This group will be followed by the "MOMA" call center (By the MOMA nures every couple weeks and by the study coordinatore and the treating Doctor at special "visits" as the study required.) The group will be monitored according to number of parameters, including treatment Adherence.
    Arm Title
    control group
    Arm Type
    Experimental
    Arm Description
    treatment as usual Control group- Treatment will continue as usual by the Doctor.(This group will allso be followed by the Study Coordinator at the same "visits" as the "Intervention group".The group will be monitored according to number of parameters, including treatment Adherence.
    Intervention Type
    Behavioral
    Intervention Name(s)
    intervention for improvement of adherence
    Intervention Description
    intervention for improvement of adherence
    Intervention Type
    Behavioral
    Intervention Name(s)
    treatment as usual
    Intervention Description
    The control group will be treated according to the usual stadard of care.
    Primary Outcome Measure Information:
    Title
    number of days of hospitalization
    Time Frame
    through study competion ,an average of 1 year.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Men & women, age 18-60 , "Maccabi Health service" patients with diagnosis of: schizophrenia, Schizo - effective or Bipolar Dis. Must have 30 days or more of hospitalization (during 3 years). Treated with psychiatric medication. Living independently or with a help of a caregiver. Is able to provide written informed consent. Exclusion Criteria: Violent, or suicidal. Drug\ Alcohol, addiction, End stage Disease (Cancer, ESRF act.) Non - in depended and without Care giver/legal guardian
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Meytal L Kahlon, MA
    Phone
    +972-52-8568283
    Ext
    0
    Email
    kahlon_me@mac.org.il
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yifat L Danon, MA
    Phone
    +972-50-8210625
    Ext
    0
    Email
    yifatad@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Asaf B Caspi, MD
    Organizational Affiliation
    Sheba Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Remote Monitoring and Support for Patients With Schizophrenia, Schizoaffective or Bipolar Disorder on Adherence

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