- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00222755
Improving Care for Patients With Bipolar Disorder (CIVIC-2)
3. januar 2008 opdateret af: University of Michigan
Improving Care for Veterans With Bipolar Disorder
The purpose of this research study is to learn whether or not a coordinated medical and psychiatric care program can improve outcomes of care for patients with bipolar disorder.
We hypothesize that coordinated care via a Care Manager will improve physical and mental health-related quality of life, improve functioning, and reduce symptoms.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Bipolar disorder is a chronic illness associated with significant personal and societal costs.
Patients with bipolar disorder also experience more general medical comorbidities than the general population.
Potential disparities exist in the receipt of medical and preventive care for individuals with serious mental illness compared to those without serious mental illness.
The goal of this study is to pilot test an adapted version of the Wagner Chronic Care Model (CCM).
Our target population will be all adult patients with a diagnosis of bipolar disorder (bipolar I, II, NOS) receiving care in the VA Pittsburgh Healthcare System.
We plan on consenting and enrolling 60 patients, in which 30 will be randomized to receive the intervention, and 30 will receive usual care.
Key components of the intervention include: 1) access to a Care Manager who will help patients make and keep appointments for general medical care by contacting patients on a regular basis; 2) a self-management program, which is education on adherence and self-management for patients by the Care Manager, including information on side-effects, bipolar disorder illness, and tips on communicating with general medical providers that will be provided during group sessions during the first 3 months of the study, and; 3) a registry that tracks patient progress maintained by the Care Manager.
Both groups will receive practice guidelines for the treatment of medical conditions tailored to the needs of patients with bipolar disorder.
Patients in the intervention arm will meet with the Care Manager after the baseline assessment, who will initially set up regular visits or contacts with the patients and work with them to connect with a primary care clinician.
A Survey Coordinator will have patients complete a baseline assessment, and then a follow up assessment at 3 and 6 months later.
Our primary outcome is changes in physical and mental health related quality of life.
Secondary outcomes include changes in symptoms and functioning.
Findings from this study will inform our long-term goal of implementing a larger scale version of the adapted CCM for veterans with bipolar disorder.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Forenede Stater, 15240
- VA Pittsburgh Healthcare System
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- >=18 years old
- active diagnosis of bipolar disorder
- have an assigned primary care provider in the VA, and
- have been seen by a provider in the Beta Team Mood Disorders clinic.
Exclusion Criteria:
- actively using substances (alcohol or drugs) at the time of enrollment
- already enrolled in a mental health program with a mobile outreach component in which clinical caregivers deliver services to the patient in the community (e.g., Assertive Community Treatment or Intensive Case Management)
- have a terminal medical illness with <3 years expected longevity, or
- unable to provide informed consent for this study. (Ineligibility to be confirmed based on registry review and Survey Coordinator's assessment)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: 2
Sædvanlig pleje
|
|
|
Eksperimentel: 1
Behavioral Care Management
|
Self-management, care management, guidelines
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Health-related quality of life (SF-12)
Tidsramme: 3 and 6 months
|
3 and 6 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Bipolar Disorder symptoms (Internal State Scale)
Tidsramme: 3 and 6 months
|
3 and 6 months
|
|
Functioning (WHO-DAS)
Tidsramme: 3 and 6 months
|
3 and 6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Amy M Kilbourne, PhD, University of Michigan
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2006
Primær færdiggørelse (Faktiske)
1. marts 2007
Studieafslutning (Faktiske)
1. marts 2007
Datoer for studieregistrering
Først indsendt
19. september 2005
Først indsendt, der opfyldte QC-kriterier
19. september 2005
Først opslået (Skøn)
22. september 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
4. januar 2008
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. januar 2008
Sidst verificeret
1. januar 2008
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 02394
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .