A Self-Management Program for Adults With Both Schizophrenia and a Co-occurring Medical Condition
Optimizing Chronic Illness Self-Management for Individuals With Schizophrenia
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Maryland
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Baltimore, Maryland, États-Unis, 21201
- Fayette Street Clinics
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Aucune intervention: Usaual Care
Usual Care; no additional intervention
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Health-related self-efficacy and recovery orientation
Délai: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Medical illness self-management skills
Délai: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Social and communication skills during interactions with health care providers
Délai: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Physical and mental health status
Délai: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Medical service use patterns
Délai: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Medication use
Délai: Measured throughout the study
|
Measured throughout the study
|
|
Neurocognition
Délai: Measured at baseline
|
Measured at baseline
|
|
Substance abuse
Délai: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Psychiatric symptoms
Délai: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Amount and seriousness of related comorbidities
Délai: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Quantitative and qualitative survey ratings
Délai: Measured throughout the study
|
Measured throughout the study
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Richard W. Goldberg, PhD, University of Maryland, College Park
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HP-00040526
- DAHBR 96-BHB
- R34MH078168 (Subvention/contrat des NIH des États-Unis)
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