Feasibility of Depression Care Management by E-mail

Depression Clinical Trial

Official title:

Pilot Trial of Depression Care Management by Electronic Secure Messaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00755235
• Other study ID #: R21MH082924
• Secondary ID: R21MH082924DSIR
• Status: Completed
• Phase: N/A
• First received: September 17, 2008
• Last updated: October 11, 2017
• Start date: April 2009
• Est. completion date: April 2010

Study information

• Verified date: October 2017
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Group Health Cooperative Center for Health Studies	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Measured at baseline and after 6 months of treatment
Secondary	Treatment Satisfaction	Single item seven point scale ranging from "very satisfied" to "very dissatisfied"	Measured after 6 months of treatment