From Compliance to Alliance: Engaging Psychiatric Patients in Illness Management
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|ClinicalTrials.gov Identifier: NCT00192751|
Recruitment Status : Unknown
Verified September 2005 by Rambam Health Care Campus.
Recruitment status was: Recruiting
First Posted : September 19, 2005
Last Update Posted : October 27, 2005
|Condition or disease||Intervention/treatment||Phase|
|Patients Diagnosed With Severe Mental Illness||Behavioral: Psychoeducational group sessions||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Psycho-Educational Intervention on Patients With Severe Mental Illness Recently Discharged From Psychiatric Inpatient Services|
|Study Start Date :||February 2004|
|Study Completion Date :||December 2006|
- Relapse prevention
- Illness management
- Satisfaction with care
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00192751
|Contact: Yael Caspi, Sc.D., M.A.||+firstname.lastname@example.org|
|Department of Psychiatry, Rambam Medical Center||Recruiting|
|Principal Investigator: Yael Caspi, Sc.D., M.A.|
|Sub-Investigator: Ehud Klein, MD|
|Principal Investigator:||Yael Caspi, Sc.D., M.A.||Department of Psychiatry, Rambam Medical Center|
|Study Chair:||Ehud Klein, MD||Department of Psychiatry, Rambam Health Center|