Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00192751
Status:
UNKNOWN
Last Update Posted:
2005-10-27
First Post:
2005-09-12
Brief Title:
From Compliance to Alliance Engaging Psychiatric Patients in Illness Management
Sponsor:
Rambam Health Care Campus
Organization:
Rambam Health Care Campus
Study Overview
Official Title:
Impact of Psycho-Educational Intervention on Patients With Severe Mental Illness Recently Discharged From Psychiatric Inpatient Services
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the benefit and impact on relapse preventionadherence to treatment and general health indices of participation in psycho-eduational group intervention among psychiatric patients with severe mental illnessrecently 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None