- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00485420
eCare for Moods: An Internet-based Management Program
Using the Internet to Provide Disease Management and Improve Compliance Among Bipolar and Depressed Patients
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study is a randomized controlled trial that includes 404 subjects, 300 subjects with bipolar disorder and 104 subjects with recurrent or chronic major depressive disorder. The study subject diagnostic groups (bipolar and depressive) are separately randomized to either usual care or to eCare and the data collected from the two diagnostic groups are analyzed separately.
All subjects randomized to the eCare intervention are assigned an eCare nurse care manager in addition to one year of access to an Internet-delivered care management and patient self-management program. While both diagnostic groups receive similar Internet-delivered services for depression, the subjects with bipolar disorder receive special services for bipolar disorder. All subjects randomized to usual care will receive their normal psychiatric care and do not have access to the website.
Study subjects are followed for 24 months and outcome measurements are taken every six months by telephone interviewers blinded to treatment assignment. Specific measures include depression and mania symptoms, severity, adherence with medication, general health, functioning at work and at home, satisfaction with care, and confidence in coping with their disorder. The primary outcomes for patients with bipolar disorder are the severity of depression and the severity of mania over time. The primary outcome for patients with recurrent or chronic depression is the severity of depression over time. The hypothesis is that Internet-based care management will have a favorable effect on the burden of bipolar disorder and/or on recurrent/chronic depression over time.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Diagnosis of bipolar or recurrent major depressive disorder and access to a computer
Exclusion Criteria:
- No diagnosis of bipolar or recurrent major depressive disorder, no computer access
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Usual Care
Member with recurrent or chronic depression receives usual specialty mental health care
|
Usual Care is augmented with internet-based education, self-monitoring and clinician monitoring
Andre navne:
|
|
Eksperimentel: Internet-based disease managment program
Usual care is augmented with internet based education, self monitoring and clinical monitoring
|
Usual Care is augmented with internet-based education, self-monitoring and clinician monitoring
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Reduction of severity of mania and depression symptoms and reduction in frequency of occurrence depression symptoms
Tidsramme: Two years
|
Two years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Satisfaction with medical care
Tidsramme: Two years
|
Two years
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Enid M Hunkeler, MA, Kaiser Permanente Division of Research
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CN-02EHunk-02-H
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