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

Schizophrenia Clinical Trial

Official title:

The Effect of Remote Monitoring and Support for Patients Suffering From Schizophrenia, Schizoaffective or Bipolar Disorder on Adherence to Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02665611
• Other study ID #: 2124-15-SMC
• Status: Not yet recruiting
• Phase: N/A
• First received: January 18, 2016
• Last updated: February 7, 2016
• Start date: February 2016
• Est. completion date: January 2018

Study information

• Verified date: January 2016
• Source: Assuta Hospital Systems
• Contact: Meytal L Kahlon, MA
• Phone: +972-52-8568283
• Email: kahlon_me[@]mac.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Behavioral:
• intervention for improvement of adherence
intervention for improvement of adherence
• treatment as usual
The control group will be treated according to the usual stadard of care.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Assuta Hospital Systems	Sheba Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of days of hospitalization		through study competion ,an average of 1 year.	No