Stage-specific Case Management for Early Psychosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2010 by The University of Hong Kong
Sponsor:
Collaborators:
Queen Mary Hospital, Hong Kong
Kwai Chung Hospital, Hong Kong
Kowloon Hospital, Hong Kong
Castle Peak Hospital, Hong Kong
Shatin Hospital, Hong Kong
Tai Po Hospital, Hong Kong
North District Hospital, Hong Kong
United Christian Hospital
Queen Elizabeth Hospital, Hong Kong
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00919620
First received: June 10, 2009
Last updated: January 13, 2010
Last verified: January 2010
  Purpose

One of the commonly adopted strategies in improving outcome in psychotic disorders is by focused, specific and intensive intervention in the initial few years of the disorder. However the effects of intervention and the optimal duration of intervention have seldom been examined in randomized studies. This study uses a randomized controlled study design to investigate the effectiveness of stage-specific case-management in improving outcome of first episode psychotic disorders. It also addresses whether two years of case-management is less effective than four years of case-management over a four year period. A total of 500 subjects, who aged 25 or above, and diagnosed with first episode psychotic disorders, will be and randomized into 3 groups: (1) standard care alone without case management, (2) two-year case management, (3) four-year case management. All groups will receive usual standard care treatment. This four-year follow-up study will assess symptoms, functioning, quality of life as well as health economics data.


Condition Intervention
Psychotic Disorders
Behavioral: stage-specific case-management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Outcome of Stage-specific Early Intervention for Psychosis in Hong Kong: A Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Functioning (social and occupational) [ Time Frame: baseline, 6-month, 12-month, 24-month, 36-month, 48-month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health economics [ Time Frame: baseline, 6-month, 12-month, 24-month, 36-month, 48-month ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: June 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: case management (4 yrs)
4-year case management and standard care
Behavioral: stage-specific case-management
Stage-specific case-management for psychosis by designated key-workers according to specified protocol
Active Comparator: case management (2 yrs) and standard care (2 yrs)
2-year case management and standard care
Behavioral: stage-specific case-management
Stage-specific case-management for psychosis by designated key-workers according to specified protocol
No Intervention: standard care (4 yrs)
standard care for 4 years

Detailed Description:

Psychotic disorder is a debilitating illness which imposes substantial impact to the patients, their families, and the society. The provision of early intervention provides a window of opportunity to minimize the social and economic burden incurred by the illness.

Many previous studies of effectiveness of early intervention used the historical control approach and are subjected to cohort effects. For example, change of medication pattern over time could potentially lead to differences in outcome. In addition, few studies provide longer-term outcome data of treatment program beyond two years. The optimal length of intervention has not been determined, and many programmes used 12-24 month intervention mainly based on resources available. It is also important to ask whether favorable effects of early intervention could be sustained over time.

The proposed study aims to address these issues by using a randomized controlled design to investigate the longer-term (4 year) outcome of patients with first episode psychosis. The study randomizes 500 patients with first episode psychotic disorders into 3 groups: (1) standard care (outpatient based care with inpatient and community care as required); (2) standard care with 2 years of add-on stage specific case-management (individualized care delivered by designated case managers according to specific protocol); and (3) standard care with 4 years of add-on stage specific case management.

The study hypothesis are: (1) both 2 years and 4 years of case management produce better outcomes than standard care alone; (2) 4 years of case management produces better outcome than 2 years of case management.

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DSM-IV diagnosis of schizophrenia, schizoaffective disorder, schizophreniform psychosis, brief psychosis, psychosis nos or delusional disorder
  • Cantonese-speaking Chinese
  • Ability to understand the nature of the study and sign informed consent
  • Capacity to participate in cognitive testing

Exclusion Criteria:

  • Organic Brain disorder
  • Known history of intellectual disability
  • Priority Follow Up (Subtarget or Target)
  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: NCT00919620

Contacts
Contact: Eric YH Chen, MD 852-22554488 eyhchen@hku.hk

Locations
China
The University of Hong Kong Recruiting
Hong Kong, China
Contact: Henry Yau       kcyau@hkucc.hku.hk   
Sponsors and Collaborators
The University of Hong Kong
Queen Mary Hospital, Hong Kong
Kwai Chung Hospital, Hong Kong
Kowloon Hospital, Hong Kong
Castle Peak Hospital, Hong Kong
Shatin Hospital, Hong Kong
Tai Po Hospital, Hong Kong
North District Hospital, Hong Kong
United Christian Hospital
Queen Elizabeth Hospital, Hong Kong
Investigators
Principal Investigator: Eric YH Chen, MD The University of Hong Kong
  More Information

No publications provided

Responsible Party: Eric Y H Chen, Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT00919620     History of Changes
Other Study ID Numbers: jcep-rct
Study First Received: June 10, 2009
Last Updated: January 13, 2010
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
Psychotic disorders
Psychoses

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on September 18, 2014