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| Name | Class |
|---|---|
| Henry Ford Health System | OTHER |
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Previous research by Mental Health Research Network (MHRN) investigators and others demonstrates that online messaging and other telehealth technologies can effectively and efficiently address premature discontinuation of depression treatment. These interventions, however, have focused on adherence after treatment initiation and have been tested primarily in non-Hispanic white populations. Less is known about the acceptability and effectiveness of different communication modalities (online messaging, mailed letters, telephone) among racial and ethnic minority populations. Implementation of electronic-Health (eHealth) technologies must take care not to exacerbate health disparities.
This clinical trial involves a pilot trial to evaluate a population-based outreach program to improve rates of depression treatment initiation among traditionally underserved racial and ethnic groups. This pilot work intends to inform a subsequent full-scale pragmatic trial to examine impact on health disparities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Participants assigned to usual care will not receive outreach messages (online or via telephone) by study staff. | |
| Outreach Messaging | Experimental | Participants in the outreach messaging arm will receive messages via online secure message system (embedded within the health care record) and/or telephone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Outreach messaging | Behavioral | Participants will receive outreach messages via health care system secure messaging and/or phone following a new diagnosis of depression made in primary care if the participant has failed to initiate treatment (pharmacotherapy or psychotherapy) within 30 days of new diagnosis. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Initiation of Formal Depression Treatment | Defined as either at least one filled prescription for any antidepressant medication or attending at least one individual psychotherapy visit. | within 60 days of randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente, Hawaii Market | Honolulu | Hawaii | 96817 | United States | ||
| Henry Ford Health |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Participants assigned to usual care will not receive outreach messages (online or via telephone) by study staff. |
| FG001 | Outreach Messaging | Participants in the outreach messaging arm will receive messages via online secure message system (embedded within the health care record) and/or telephone. Outreach messaging: Participants will receive outreach messages via health care system secure messaging and/or phone following a new diagnosis of depression made in primary care if the participant has failed to initiate treatment (pharmacotherapy or psychotherapy) within 30 days of new diagnosis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Individuals randomly assigned to usual care or outreach messaging
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Participants assigned to usual care will not receive outreach messages (online or via telephone) by study staff. |
| BG001 | Outreach Messaging | Participants in the outreach messaging arm will receive messages via online secure message system (embedded within the health care record) and/or telephone. Outreach messaging: Participants will receive outreach messages via health care system secure messaging and/or phone following a new diagnosis of depression made in primary care if the participant has failed to initiate treatment (pharmacotherapy or psychotherapy) within 30 days of new diagnosis. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Initiation of Formal Depression Treatment | Defined as either at least one filled prescription for any antidepressant medication or attending at least one individual psychotherapy visit. | Posted | Count of Participants | Participants | within 60 days of randomization |
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Adverse event data were collected from randomization to 60-days post-randomization.
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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 | Usual Care | Participants assigned to usual care will not receive outreach messages (online or via telephone) by study staff. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Vanessa Simiola | Kaiser Permanente, Center for Integrated Health Care Research | 808-432-7777 | 1940 | vanessa.l.simiola@kp.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 25, 2023 | Mar 23, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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|
| Detroit |
| Michigan |
| 48202 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| PHQ-9 total score | Patient Health Questionnaire-9 (PHQ-9) is a self-report measure of depressive symptom severity over the past two weeks. The total score ranges from 0-27, calculated by summing responses to nine items (each scored 0-3). Higher scores indicate more severe depressive symptoms (worse outcome), while lower scores indicate fewer symptoms (better outcome). | Mean | Standard Deviation | units on a scale |
|
|
|
| 0 |
| 152 |
| 0 |
| 152 |
| 0 |
| 152 |
| EG001 | Outreach Messaging | Participants in the outreach messaging arm will receive messages via online secure message system (embedded within the health care record) and/or telephone. Outreach messaging: Participants will receive outreach messages via health care system secure messaging and/or phone following a new diagnosis of depression made in primary care if the participant has failed to initiate treatment (pharmacotherapy or psychotherapy) within 30 days of new diagnosis. | 0 | 157 | 0 | 157 | 0 | 157 |
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