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| ID | Type | Description | Link |
|---|---|---|---|
| R21MH082924 | U.S. NIH Grant/Contract | View source | |
| DSIR 82-SEDR |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Participants will receive depression care management by secure messaging. |
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| 2 | No Intervention | Participants will receive their usual care, with no additional education or care management services. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Depression care management by secure messaging | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Satisfaction | Single item seven point scale ranging from "very satisfied" to "very dissatisfied" | Measured after 6 months of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory E. Simon, MD, MPH | Group Health Cooperative Center for Health Studies | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Group Health Cooperative Center for Health Studies | Seattle | Washington | 98101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21384219 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Secure Messaging Care Management | Participants will receive depression care management by secure messaging. |
| FG001 | Usual Care | Participants will receive their usual care, with no additional education or care management services. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Secure Messaging Care Management | Participants will receive depression care management by secure messaging. |
| BG001 | Usual Care | Participants will receive their usual care, with no additional education or care management services. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Analysis included all participants participating in outcome assessment | Posted | Mean | Standard Deviation | units on a scale | Measured at baseline and after 6 months of treatment |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Secure Messaging Care Management | Participants will receive depression care management by secure messaging. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide attempt | Psychiatric disorders | Systematic Assessment |
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Findings apply only to patients who choose to communicate by online messaging.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gregory Simon, Principal Investigator | Group Health Research Institute | 206-287-2979 | simon.g@ghc.org |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Treatment Satisfaction | Single item seven point scale ranging from "very satisfied" to "very dissatisfied" | Posted | Number | participants | Measured after 6 months of treatment |
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| 0 |
| 104 |
| 0 |
| 104 |
| EG001 | Usual Care | Participants will receive their usual care, with no additional education or care management services. | 0 | 93 | 0 | 93 |
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