Feasibility of Depression Care Management by E-mail

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Group Health Cooperative
ClinicalTrials.gov Identifier:
NCT00755235
First received: September 17, 2008
Last updated: April 5, 2013
Last verified: April 2013
  Purpose

This study will test whether an electronic system that monitors and sends messages to help people with depression could be feasible, acceptable, and potentially effective as a treatment.


Condition Intervention
Depression
Other: Depression care management by secure messaging

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Pilot Trial of Depression Care Management by Electronic Secure Messaging

Further study details as provided by Group Health Cooperative:

Primary Outcome Measures:
  • 20-Item Symptom Checklist Depression Scale [ Time Frame: Measured at baseline and after 6 months of treatment ] [ Designated as safety issue: No ]
    20-item depression severity scalse adapted from longer SCL-90. Mean score ranges from 0 to 4 with scores above 1.5 indicating moderate depression.


Secondary Outcome Measures:
  • Treatment Satisfaction [ Time Frame: Measured after 6 months of treatment ] [ Designated as safety issue: No ]
    Single item seven point scale ranging from "very satisfied" to "very dissatisfied"


Enrollment: 208
Study Start Date: April 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive depression care management by secure messaging.
Other: Depression care management by secure messaging
Participants will receive electronic messages welcoming them and monitoring their antidepressant treatment. Care managers will use monitoring data to aid participants' physicians, coordinate physician follow-ups, facilitate emergency care, and facilitate specialty referrals. Care managers will also provide motivation and education to participants.
Other Names:
  • online messaging
  • email
No Intervention: 2
Participants will receive their usual care, with no additional education or care management services.

Detailed Description:

Symptoms of depression, such as persistent sadness, problems sleeping, and inability to feel pleasure, interfere with the daily lives of more than 20 million Americans. Previous research indicates that telephone care management systems improve the quality and outcomes of depression care, but are too expensive to be used widely. Using secure messaging over e-mail would be more cost effective than telephone care. This study will examine whether a secure messaging care management program would be feasible, based on whether participants are willing to sign up for and continue with the program, and whether the program has a positive effect on those participants enrolled in the program.

Potential participants for this study will be contacted via e-mail, with a follow-up telephone call if they do not respond to the e-mail message. Only people who have used e-mails in the past year and who are starting antidepressant treatment will be contacted. The percentage of people contacted who enroll will be recorded.

Participation in this study will last 6 months. Participants will be randomly assigned to receive either a secure messaging care management program, based on effective telephone management programs, or their usual care with no intervention. Those receiving the secure messaging program will receive an initial welcome message and monitoring messages approximately 2, 6, and 10 weeks after treatment has begun. The monitoring messages will include structured assessments of depression severity, medication adherence, medication side effects, and barriers to continuing treatment. Participants who do not respond to monitoring messages will receive up to two e-mailed reminders. Care managers will analyze the results of monitoring messages, provide feedback and recommendations to physicians, coordinate physician follow-ups, and facilitate emergency care or specialty referrals. Care managers will also provide patients with motivation, based on semi-scripted protocols, and education concerning their disorder and treatment. Measures of the success of the study will be taken at enrollment and after 6 months of participation. Specific measurements will include the response rate of recruitment e-mails, response rate for follow-up data collection, proportion of those in the secure messaging program who complete the monitoring assessments, effects of the program on antidepressant treatment, and effects of the program on patient satisfaction.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient at Capitol Hill or Rainier clinics of Group Health Cooperative in Seattle
  • New prescription of an antidepressant, defined by an interval of at least 180 days since a previous antidepressant prescription
  • Indication of depression, defined by a visit diagnosis of major depressive disorder (Internal Classification of Diseases 9th Revision [ICD9] codes 296.2x or 296.3x) within 30 days of the first prescription
  • Has used secure messaging, or e-mailing, at least twice in the last 12 months

Exclusion Criteria:

  • Any diagnosis of psychotic disorder or bipolar disorder in the prior 2 years
  • Any prescription for mood stabilizer or antipsychotic medication in the prior 2 years
  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: NCT00755235

Locations
United States, Washington
Group Health Cooperative Center for Health Studies
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Group Health Cooperative
Investigators
Principal Investigator: Gregory E. Simon, MD, MPH Group Health Cooperative Center for Health Studies
  More Information

Publications:
Responsible Party: Group Health Cooperative
ClinicalTrials.gov Identifier: NCT00755235     History of Changes
Other Study ID Numbers: R21 MH082924, R21MH082924, DSIR 82-SEDR
Study First Received: September 17, 2008
Results First Received: July 22, 2011
Last Updated: April 5, 2013
Health Authority: United States: Federal Government

Keywords provided by Group Health Cooperative:
Depression
Primary care
Effectiveness
Care management

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2014