Feasibility of Depression Care Management by E-mail
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Depression care management by secure messaging
Sponsored by
About this trial
This is an interventional health services research trial for Depression focused on measuring Depression, Primary care, Effectiveness, Care management
Eligibility 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
Sites / Locations
- Group Health Cooperative Center for Health Studies
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Participants will receive depression care management by secure messaging.
Participants will receive their usual care, with no additional education or care management services.
Outcomes
Primary Outcome Measures
20-Item Symptom Checklist Depression Scale
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
Single item seven point scale ranging from "very satisfied" to "very dissatisfied"
Full Information
NCT ID
NCT00755235
First Posted
September 17, 2008
Last Updated
October 11, 2017
Sponsor
Kaiser Permanente
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00755235
Brief Title
Feasibility of Depression Care Management by E-mail
Official Title
Pilot Trial of Depression Care Management by Electronic Secure Messaging
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Primary care, Effectiveness, Care management
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
208 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive depression care management by secure messaging.
Arm Title
2
Arm Type
No Intervention
Arm Description
Participants will receive their usual care, with no additional education or care management services.
Intervention Type
Other
Intervention Name(s)
Depression care management by secure messaging
Other Intervention Name(s)
online messaging, email
Intervention Description
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.
Primary Outcome Measure Information:
Title
20-Item Symptom Checklist Depression Scale
Description
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.
Time Frame
Measured at baseline and after 6 months of treatment
Secondary Outcome Measure Information:
Title
Treatment Satisfaction
Description
Single item seven point scale ranging from "very satisfied" to "very dissatisfied"
Time Frame
Measured after 6 months of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory E. Simon, MD, MPH
Organizational Affiliation
Group Health Cooperative Center for Health Studies
Official's Role
Principal Investigator
Facility Information:
Facility Name
Group Health Cooperative Center for Health Studies
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21384219
Citation
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.
Results Reference
result
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