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A Self-Management Program for Adults With Both Schizophrenia and a Co-occurring Medical Condition

23 augusti 2019 uppdaterad av: Richard Goldberg, University of Maryland, Baltimore

Optimizing Chronic Illness Self-Management for Individuals With Schizophrenia

This study will develop and evaluate the effectiveness of a self-management program for adults living with both schizophrenia and a co-occurring medical condition.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

100

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Maryland
      • Baltimore, Maryland, Förenta staterna, 21201
        • Fayette Street Clinics

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 64 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 1
Participants will receive a self-management program for chronic illness
Beteende: Self-management program for chronic illness
Self-management program for chronic illness will include between 10 and 16 psychoeducational and supportive group sessions.
Inget ingripande: Usaual Care
Usual Care; no additional intervention

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Health-related self-efficacy and recovery orientation
Tidsram: Measured at pre- and post-intervention
Measured at pre- and post-intervention
Medical illness self-management skills
Tidsram: Measured at pre- and post-intervention
Measured at pre- and post-intervention
Social and communication skills during interactions with health care providers
Tidsram: Measured at pre- and post-intervention
Measured at pre- and post-intervention
Physical and mental health status
Tidsram: Measured at pre- and post-intervention
Measured at pre- and post-intervention
Medical service use patterns
Tidsram: Measured at pre- and post-intervention
Measured at pre- and post-intervention

Sekundära resultatmått

Resultatmått
Tidsram
Medication use
Tidsram: Measured throughout the study
Measured throughout the study
Neurocognition
Tidsram: Measured at baseline
Measured at baseline
Substance abuse
Tidsram: Measured at pre- and post-intervention
Measured at pre- and post-intervention
Psychiatric symptoms
Tidsram: Measured at pre- and post-intervention
Measured at pre- and post-intervention
Amount and seriousness of related comorbidities
Tidsram: Measured at pre- and post-intervention
Measured at pre- and post-intervention
Quantitative and qualitative survey ratings
Tidsram: Measured throughout the study
Measured throughout the study

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Maryland, Baltimore

Samarbetspartners

National Institute of Mental Health (NIMH)

Utredare

  • Huvudutredare: Richard W. Goldberg, PhD, University of Maryland, College Park

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 september 2007

Primärt slutförande (Faktisk)

1 maj 2015

Avslutad studie (Faktisk)

1 maj 2015

Studieregistreringsdatum

Först inskickad

4 september 2007

Först inskickad som uppfyllde QC-kriterierna

4 september 2007

Första postat (Uppskatta)

5 september 2007

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

28 augusti 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 augusti 2019

Senast verifierad

1 augusti 2019

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • HP-00040526
  • DAHBR 96-BHB
  • R34MH078168 (U.S.S. NIH-anslag/kontrakt)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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