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A Self-Management Program for Adults With Both Schizophrenia and a Co-occurring Medical Condition
Optimizing Chronic Illness Self-Management for Individuals With Schizophrenia
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21201
- Fayette Street Clinics
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
- Pregnant
- 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
- Psychiatric instability, as defined by a mental health provider
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 1
Participants will receive a self-management program for chronic illness
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Self-management program for chronic illness will include between 10 and 16 psychoeducational and supportive group sessions.
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Geen tussenkomst: Usaual Care
Usual Care; no additional intervention
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Health-related self-efficacy and recovery orientation
Tijdsspanne: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
Medical illness self-management skills
Tijdsspanne: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
Social and communication skills during interactions with health care providers
Tijdsspanne: Measured at pre- and post-intervention
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Measured at pre- and post-intervention
|
Physical and mental health status
Tijdsspanne: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
Medical service use patterns
Tijdsspanne: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Medication use
Tijdsspanne: Measured throughout the study
|
Measured throughout the study
|
Neurocognition
Tijdsspanne: Measured at baseline
|
Measured at baseline
|
Substance abuse
Tijdsspanne: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
Psychiatric symptoms
Tijdsspanne: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
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Amount and seriousness of related comorbidities
Tijdsspanne: Measured at pre- and post-intervention
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Measured at pre- and post-intervention
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Quantitative and qualitative survey ratings
Tijdsspanne: Measured throughout the study
|
Measured throughout the study
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Richard W. Goldberg, PhD, University of Maryland, College Park
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HP-00040526
- DAHBR 96-BHB
- R34MH078168 (Subsidie/contract van de Amerikaanse NIH)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Self-management program for chronic illness
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University of WashingtonNational Center for Complementary and Integrative Health (NCCIH)Actief, niet wervend
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Kaiser PermanenteVoltooid