From Compliance to Alliance: Engaging Psychiatric Patients in Illness Management

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Rambam Health Care Campus.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00192751
First received: September 12, 2005
Last updated: October 26, 2005
Last verified: September 2005
  Purpose

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.


Condition Intervention
Patients Diagnosed With Severe Mental Illness
Behavioral: Psychoeducational group sessions

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Official Title: Impact of Psycho-Educational Intervention on Patients With Severe Mental Illness Recently Discharged From Psychiatric Inpatient Services

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Relapse prevention
  • Illness management

Secondary Outcome Measures:
  • Satisfaction with care

Estimated Enrollment: 150
Study Start Date: February 2004
Estimated Study Completion Date: December 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00192751

Contacts
Contact: Yael Caspi, Sc.D., M.A. +972-4-854-1987 y_caspi@rambam.health.gov.il

Locations
Israel
Department of Psychiatry, Rambam Medical Center Recruiting
Haifa, Israel
Principal Investigator: Yael Caspi, Sc.D., M.A.         
Sub-Investigator: Ehud Klein, MD         
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00192751     History of Changes
Other Study ID Numbers: compliance_CTIL
Study First Received: September 12, 2005
Last Updated: October 26, 2005
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:
Schizophrenia
Major depression
Bipolar disorder
Compliance
Relapse prevention

Additional relevant MeSH terms:
Mental Disorders

ClinicalTrials.gov processed this record on October 30, 2014