NCT02665611

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 .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Feb 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

February 9, 2016

Status Verified

January 1, 2016

Enrollment Period

1.9 years

First QC Date

January 18, 2016

Last Update Submit

February 7, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • number of days of hospitalization

    through study competion ,an average of 1 year.

Study Arms (2)

intervention group

EXPERIMENTAL

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.

Behavioral: intervention for improvement of adherence

control group

EXPERIMENTAL

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.

Behavioral: treatment as usual

Interventions

intervention for improvement of adherence

intervention group

The control group will be treated according to the usual stadard of care.

control group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersBipolar Disorder

Interventions

MethodsTherapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Asaf B Caspi, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Meytal L Kahlon, MA

CONTACT

Yifat L Danon, MA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2016

First Posted

January 28, 2016

Study Start

February 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

February 9, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will share