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| Descriptive Information Fields | |||||||||
| Brief Title † | A Self-Management Program for Adults With Both Schizophrenia and a Co-Occurring Medical Condition | ||||||||
| Official Title † | Optimizing Chronic Illness Self-Management for Individuals With Schizophrenia | ||||||||
| 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. |
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| 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. |
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| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Health-related self-efficacy and recovery orientation [ Time Frame: Measured at pre- and post-intervention ] [ Designated as safety issue: No ] Medical illness self-management skills [ Time Frame: Measured at pre- and post-intervention ] [ Designated as safety issue: No ] Social and communication skills during interactions with health care providers [ Time Frame: Measured at pre- and post-intervention ] [ Designated as safety issue: No ] Physical and mental health status [ Time Frame: Measured at pre- and post-intervention ] [ Designated as safety issue: No ] Medical service use patterns [ Time Frame: Measured at pre- and post-intervention ] [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | Medication use [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ] Neurocognition [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ] Substance abuse [ Time Frame: Measured at pre- and post-intervention ] [ Designated as safety issue: No ] Psychiatric symptoms [ Time Frame: Measured at pre- and post-intervention ] [ Designated as safety issue: No ] Amount and seriousness of related comorbidities [ Time Frame: Measured at pre- and post-intervention ] [ Designated as safety issue: No ] Quantitative and qualitative survey ratings [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ] |
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| Condition † | Schizophrenia | ||||||||
| Intervention † | Behavioral: Self-management program for chronic illness | ||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 60 | ||||||||
| Start Date † | September 2007 | ||||||||
| Completion Date | March 2010 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 64 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00525304 | ||||||||
| Organization ID | R34 MH078168 | ||||||||
| Secondary IDs †† | DAHBR 96-BHB | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
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| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | March 2008 | ||||||||
| First Received Date † | September 4, 2007 | ||||||||
| Last Updated Date | March 4, 2008 | ||||||||
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