- ICH GCP
- Registr klinických studií v USA
- Klinická 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
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Maryland
-
Baltimore, Maryland, Spojené státy, 21201
- Fayette Street Clinics
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: 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.
|
Žádný zásah: Usaual Care
Usual Care; no additional intervention
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
Health-related self-efficacy and recovery orientation
Časové okno: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
Medical illness self-management skills
Časové okno: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
Social and communication skills during interactions with health care providers
Časové okno: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
Physical and mental health status
Časové okno: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
Medical service use patterns
Časové okno: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
Medication use
Časové okno: Measured throughout the study
|
Measured throughout the study
|
Neurocognition
Časové okno: Measured at baseline
|
Measured at baseline
|
Substance abuse
Časové okno: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
Psychiatric symptoms
Časové okno: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
Amount and seriousness of related comorbidities
Časové okno: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
Quantitative and qualitative survey ratings
Časové okno: Measured throughout the study
|
Measured throughout the study
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Richard W. Goldberg, PhD, University of Maryland, College Park
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- HP-00040526
- DAHBR 96-BHB
- R34MH078168 (Grant/smlouva NIH USA)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Self-management program for chronic illness
-
Stanford UniversityDokončeno
-
Kutahya Health Sciences UniversityDokončenoDiabetes mellitus, typ 2 | Zmocnění pacienta | ZmocněníKrocan
-
LMC Diabetes & Endocrinology Ltd.Dokončeno
-
Institute of Liver and Biliary Sciences, IndiaDokončenoPacienti s rakovinouIndie
-
Universidad Nacional de ColombiaZatím nenabíráme
-
University of South CarolinaNational Institute on Aging (NIA)Nábor
-
Stanford UniversityHealthCore, Inc.Dokončeno
-
Federal University of Minas GeraisDokončeno
-
Singapore Eye Research InstituteUniversity of Melbourne; Curtin University; Singapore National Eye Centre; Ministry...NeznámýGlaukom | Diabetická retinopatie | Věkem podmíněné makulární degenerace | Nízké vidění | Chronická onemocněníSingapur
-
University of WashingtonDokončenoPoranění míchySpojené státy