NCT00485420

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
404

participants targeted

Target at P75+ for not_applicable major-depressive-disorder

Timeline
Completed

Started Sep 2002

Longer than P75 for not_applicable major-depressive-disorder

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

April 19, 2012

Status Verified

April 1, 2012

Enrollment Period

7 years

First QC Date

June 11, 2007

Last Update Submit

April 18, 2012

Conditions

Major Depressive DisorderBipolar Disorder

Keywords

Internet based disease management program

Outcome Measures

Primary Outcomes (1)

  • Reduction of severity of mania and depression symptoms and reduction in frequency of occurrence depression symptoms

    Two years

Secondary Outcomes (1)

  • Satisfaction with medical care

    Two years

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Member with recurrent or chronic depression receives usual specialty mental health care

Other: Internet based disease management program

Internet-based disease managment program

EXPERIMENTAL

Usual care is augmented with internet based education, self monitoring and clinical monitoring

Other: Internet based disease management program

Interventions

Internet based disease management programOTHER

Usual Care is augmented with internet-based education, self-monitoring and clinician monitoring

Also known as: Care management via the internet
Internet-based disease managment programUsual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of bipolar or recurrent major depressive disorder and access to a computer

You may not qualify if:

  • No diagnosis of bipolar or recurrent major depressive disorder, no computer access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depressive Disorder, MajorBipolar Disorder

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBipolar and Related Disorders

Study Officials

  • Enid M Hunkeler, MA

    Kaiser Permanente Division of Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2007

First Posted

June 13, 2007

Study Start

September 1, 2002

Primary Completion

September 1, 2009

Study Completion

December 1, 2009

Last Updated

April 19, 2012

Record last verified: 2012-04