From Compliance to Alliance: Engaging Psychiatric Patients in Illness Management
Primary Purpose
Patients Diagnosed With Severe Mental Illness
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Psychoeducational group sessions
Sponsored by
About this trial
This is an interventional educational/counseling/training trial for Patients Diagnosed With Severe Mental Illness focused on measuring Schizophrenia, Major depression, Bipolar disorder, Compliance, Relapse prevention
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of severe mental illness, younger than 70 years of age, recently discharged from psychiatric inpatient services at the Rambam Medical Health Center. Exclusion Criteria: Diagnoses other than schizophrenia, major depression and bipolar disorders; 70 + years of age; organic problems
Sites / Locations
- Department of Psychiatry, Rambam Medical CenterRecruiting
Outcomes
Primary Outcome Measures
Relapse prevention
Illness management
Secondary Outcome Measures
Satisfaction with care
Full Information
NCT ID
NCT00192751
First Posted
September 12, 2005
Last Updated
October 26, 2005
Sponsor
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT00192751
Brief Title
From Compliance to Alliance: Engaging Psychiatric Patients in Illness Management
Official Title
Impact of Psycho-Educational Intervention on Patients With Severe Mental Illness Recently Discharged From Psychiatric Inpatient Services
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine the benefit and impact on relapse prevention,adherence to treatment and general health indices of participation in psycho-eduational group intervention among psychiatric patients with severe mental illness,recently discharged from inpatient services.
Detailed Description
Medication non-compliance, estimated to affect 50% of all psychiatric patients, was shown to be strongly associated with an elevated risk for relapse, readmission to psychiatric inpatient care, longer length of stay and suicide, resulting in elevated costs across the health care system. The proposed project seeks to bridge the gap between the significant progress of recent years in psycho-pharmacology that produced more efficient 'newer generation' medications, and the continuing unanswered problem of non-compliance, by applying knowledge from clinical decision-making theories and recent evidence-based research on the management of severe mental illness.
In Phase I of the project, an epidemiological survey will be conducted to evaluate the magnitude and correlates of the problem in patients attending walk-in crisis clinic , using Treatment Compliance Assessment and Decision-Making Assessment Tools, both developed by the researchers. An 8-module psycho-educational intervention protocol emphasizing illness management and optimization of health care decision-making will then be designed and implemented.
In Phase II, eligible outpatient clients will be randomly assigned to either Intervention or Standard Care conditions, and followed for a period of 15 months. Repeated assessments will include pre-post measures of knowledge, treatment compliance, and decision-making, and on outcome measures of relapse such as hospitalizations and symptoms, functioning, self-efficacy, quality of life, and satisfaction with services.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients Diagnosed With Severe Mental Illness
Keywords
Schizophrenia, Major depression, Bipolar disorder, Compliance, Relapse prevention
7. Study Design
Primary Purpose
Educational/Counseling/Training
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducational group sessions
Primary Outcome Measure Information:
Title
Relapse prevention
Title
Illness management
Secondary Outcome Measure Information:
Title
Satisfaction with care
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:
Clinical diagnosis of severe mental illness, younger than 70 years of age, recently discharged from psychiatric inpatient services at the Rambam Medical Health Center.
Exclusion Criteria:
Diagnoses other than schizophrenia, major depression and bipolar disorders; 70 + years of age; organic problems
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yael Caspi, Sc.D., M.A.
Phone
+972-4-854-1987
Email
y_caspi@rambam.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yael Caspi, Sc.D., M.A.
Organizational Affiliation
Department of Psychiatry, Rambam Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ehud Klein, MD
Organizational Affiliation
Department of Psychiatry, Rambam Health Center
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Psychiatry, Rambam Medical Center
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yael Caspi, Sc.D., M.A.
First Name & Middle Initial & Last Name & Degree
Ehud Klein, MD
12. IPD Sharing Statement
Learn more about this trial
From Compliance to Alliance: Engaging Psychiatric Patients in Illness Management
We'll reach out to this number within 24 hrs