- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Maryland
-
Baltimore, Maryland, Stati Uniti, 21201
- Fayette Street Clinics
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
|
Nessun intervento: Usaual Care
Usual Care; no additional intervention
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Health-related self-efficacy and recovery orientation
Lasso di tempo: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Medical illness self-management skills
Lasso di tempo: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Social and communication skills during interactions with health care providers
Lasso di tempo: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Physical and mental health status
Lasso di tempo: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Medical service use patterns
Lasso di tempo: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Medication use
Lasso di tempo: Measured throughout the study
|
Measured throughout the study
|
|
Neurocognition
Lasso di tempo: Measured at baseline
|
Measured at baseline
|
|
Substance abuse
Lasso di tempo: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Psychiatric symptoms
Lasso di tempo: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Amount and seriousness of related comorbidities
Lasso di tempo: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Quantitative and qualitative survey ratings
Lasso di tempo: Measured throughout the study
|
Measured throughout the study
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Richard W. Goldberg, PhD, University of Maryland, College Park
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- HP-00040526
- DAHBR 96-BHB
- R34MH078168 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .