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Feasibility of Depression Care Management by E-mail

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ClinicalTrials.gov Identifier: NCT00755235
Recruitment Status : Completed
First Posted : September 18, 2008
Results First Posted : June 1, 2012
Last Update Posted : November 13, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Kaiser Permanente

Tracking Information
First Submitted Date  ICMJE September 17, 2008
First Posted Date  ICMJE September 18, 2008
Results First Submitted Date  ICMJE July 22, 2011
Results First Posted Date  ICMJE June 1, 2012
Last Update Posted Date November 13, 2017
Study Start Date  ICMJE April 2009
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2012)
20-Item Symptom Checklist Depression Scale [ Time Frame: Measured at baseline and after 6 months of treatment ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 17, 2008)
20-Item Symptom Checklist Depression Scale [ Time Frame: Measured at baseline and after 6 months of treatment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2012)
Treatment Satisfaction [ Time Frame: Measured after 6 months of treatment ]
Single item seven point scale ranging from "very satisfied" to "very dissatisfied"
Original Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2008)
Treatment Satisfaction [ Time Frame: Measured after 6 months of treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility of Depression Care Management by E-mail
Official Title  ICMJE Pilot Trial of Depression Care Management by Electronic Secure Messaging
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Depression
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: 1
    Participants will receive depression care management by secure messaging.
    Intervention: Other: Depression care management by secure messaging
  • No Intervention: 2
    Participants will receive their usual care, with no additional education or care management services.
Publications * Simon GE, Ralston JD, Savarino J, Pabiniak C, Wentzel C, Operskalski BH. Randomized trial of depression follow-up care by online messaging. J Gen Intern Med. 2011 Jul;26(7):698-704. doi: 10.1007/s11606-011-1679-8. Epub 2011 Mar 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 31, 2012)
208
Original Estimated Enrollment  ICMJE
 (submitted: September 17, 2008)
200
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00755235
Other Study ID Numbers  ICMJE R21MH082924( U.S. NIH Grant/Contract )
R21MH082924 ( U.S. NIH Grant/Contract )
DSIR 82-SEDR
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kaiser Permanente
Study Sponsor  ICMJE Kaiser Permanente
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Gregory E. Simon, MD, MPH Group Health Cooperative Center for Health Studies
PRS Account Kaiser Permanente
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP