Trial record 1 of 1 for:    ecare for moods
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eCare for Moods: An Internet-based Management Program

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00485420
First received: June 11, 2007
Last updated: April 18, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Major Depressive Disorder
Bipolar Disorder
Other: Internet based disease management program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Using the Internet to Provide Disease Management and Improve Compliance Among Bipolar and Depressed Patients

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Reduction of severity of mania and depression symptoms and reduction in frequency of occurrence depression symptoms [ Time Frame: Two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Satisfaction with medical care [ Time Frame: Two years ] [ Designated as safety issue: No ]

Enrollment: 404
Study Start Date: September 2002
Study Completion Date: December 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Usual Care
Member with recurrent or chronic depression receives usual specialty mental health care
Other: Internet based disease management program
Usual Care is augmented with internet-based education, self-monitoring and clinician monitoring
Other Name: Care management via the internet
Experimental: Internet-based disease managment program
Usual care is augmented with internet based education, self monitoring and clinical monitoring
Other: Internet based disease management program
Usual Care is augmented with internet-based education, self-monitoring and clinician monitoring
Other Name: Care management via the internet

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00485420

Sponsors and Collaborators
Kaiser Permanente
Eli Lilly and Company
Investigators
Principal Investigator: Enid M Hunkeler, MA Kaiser Permanente Division of Research
  More Information

No publications provided

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00485420     History of Changes
Other Study ID Numbers: CN-02EHunk-02-H
Study First Received: June 11, 2007
Last Updated: April 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Kaiser Permanente:
Internet based disease management program

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Bipolar Disorder
Disease
Mood Disorders
Mental Disorders
Behavioral Symptoms
Affective Disorders, Psychotic
Pathologic Processes

ClinicalTrials.gov processed this record on October 01, 2014