- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00525304
A Self-Management Program for Adults With Both Schizophrenia and a Co-occurring Medical Condition
Optimizing Chronic Illness Self-Management for Individuals With Schizophrenia
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Maryland
-
Baltimore, Maryland, Vereinigte Staaten, 21201
- Fayette Street Clinics
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 1
Participants will receive a self-management program for chronic illness
|
Self-management program for chronic illness will include between 10 and 16 psychoeducational and supportive group sessions.
|
|
Kein Eingriff: Usaual Care
Usual Care; no additional intervention
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Health-related self-efficacy and recovery orientation
Zeitfenster: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Medical illness self-management skills
Zeitfenster: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Social and communication skills during interactions with health care providers
Zeitfenster: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Physical and mental health status
Zeitfenster: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Medical service use patterns
Zeitfenster: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Medication use
Zeitfenster: Measured throughout the study
|
Measured throughout the study
|
|
Neurocognition
Zeitfenster: Measured at baseline
|
Measured at baseline
|
|
Substance abuse
Zeitfenster: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Psychiatric symptoms
Zeitfenster: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Amount and seriousness of related comorbidities
Zeitfenster: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Quantitative and qualitative survey ratings
Zeitfenster: Measured throughout the study
|
Measured throughout the study
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Richard W. Goldberg, PhD, University of Maryland, College Park
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- HP-00040526
- DAHBR 96-BHB
- R34MH078168 (US NIH Stipendium/Vertrag)
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-
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