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Clinical Trials/NCT00525304
NCT00525304
Completed
Not Applicable

Optimizing Chronic Illness Self-Management for Individuals With Schizophrenia

University of Maryland, Baltimore1 site in 1 country100 target enrollmentSeptember 2007
ConditionsSchizophrenia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
University of Maryland, Baltimore
Enrollment
100
Locations
1
Primary Endpoint
Medical illness self-management skills
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

This study will develop and evaluate the effectiveness of a self-management program for adults living with both schizophrenia and a co-occurring medical condition.

Detailed Description

Schizophrenia is a life-long brain disorder affecting approximately 1 percent of Americans each year. Schizophrenia can be extremely disabling, causing people to hear voices, experience paranoia or hallucinations, and believe that others are controlling their thoughts. People with schizophrenia also experience increased rates of concurrent medical conditions, such as diabetes, respiratory illness, and heart disease. This can make holding a job or even caring for oneself very difficult. The purpose of this study is to develop and evaluate a self-management program for adults living with both schizophrenia and a concurrent medical condition. Participants in this open-label study will attend 10 to 16 group sessions led by two group leaders. Group sessions will meet each week for an hour during which participants will learn new skills to help them take responsibility for the daily management of chronic medical conditions. In addition to learning how to communicate more effectively with medical providers, participants will learn about healthy eating, the importance of physical activity, addictive behaviors that can worsen health conditions, and proper use of medications. Homework will be assigned weekly for participants to review skills learned in each session. After each session, participants will complete a survey to evaluate the session's effectiveness. At the end of the study, participants will attend one additional group meeting and an individual interview to discuss the overall effectiveness of the intervention and their experiences in the group sessions. The results of this study will be used to evaluate and improve the self-management program for future use.

Registry
clinicaltrials.gov
Start Date
September 2007
End Date
May 2015
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Richard Goldberg

PI

University of Maryland, Baltimore

Eligibility Criteria

Inclusion Criteria

  • Meets DSM-IV criteria for schizophrenia or schizoaffective disorder
  • Current documented chart diagnosis of at least one chronic medical condition
  • Received clinic services for a minimum of 3 months prior to study entry
  • English-speaking
  • Willing to use an effective form of birth control throughout the study if sexually active

Exclusion Criteria

  • History of a serious neurological disorder or head trauma with loss of consciousness
  • Diagnosed with mental retardation or dementia
  • Diagnosed with end stage organ disease
  • Currently receiving chemotherapy and/or radiation treatment for cancer
  • Received psychiatric hospitalization less than 3 months prior to study entry date
  • Blind and/or deaf
  • Infected with HIV with a CD4 count under 350
  • Diagnosis of AIDS
  • Diagnosis of anorexia
  • Problematic substance use, as defined by a mental health provider

Outcomes

Primary Outcomes

Medical illness self-management skills

Time Frame: Measured at pre- and post-intervention

Physical and mental health status

Time Frame: Measured at pre- and post-intervention

Medical service use patterns

Time Frame: Measured at pre- and post-intervention

Social and communication skills during interactions with health care providers

Time Frame: Measured at pre- and post-intervention

Health-related self-efficacy and recovery orientation

Time Frame: Measured at pre- and post-intervention

Secondary Outcomes

  • Psychiatric symptoms(Measured at pre- and post-intervention)
  • Amount and seriousness of related comorbidities(Measured at pre- and post-intervention)
  • Medication use(Measured throughout the study)
  • Neurocognition(Measured at baseline)
  • Substance abuse(Measured at pre- and post-intervention)
  • Quantitative and qualitative survey ratings(Measured throughout the study)

Study Sites (1)

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