Clinical trial NCT00485420: eCare for Moods: An Internet-based Management Program
Official title: Using the Internet to Provide Disease Management and Improve Compliance Among Bipolar and Depressed Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Bipolar Disorder
Keywords: Internet based disease management program
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2007-06-13
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study aim is to explore the effect of a comprehensive Internet-based disease management program for bipolar disorder and recurrent or chronic major depression on clinical outcomes and satisfaction with care.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction of severity of mania and depression symptoms and reduction in frequency of occurrence depression symptoms
timeFrame: Two years
Secondary outcomes:
measure: Satisfaction with medical care
timeFrame: Two years
Other outcomes:
Locations:
Study officials:
affiliation: Kaiser Permanente Division of Research
name: Enid M Hunkeler, MA
role: PRINCIPAL_INVESTIGATOR
References: