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This is a pilot feasibility study of a mobile health tool (smartphone app) for primary care patients receiving treatment for depression or anxiety delivered in an integrated primary care-based behavioral health program.
This research is a feasibility pilot study of a smartphone app using mixed methods. The research seeks to answer the question: "Is a mobile health tool for patient self-management feasible, useful, appropriate, and acceptable for patients and care managers for patients with depression or anxiety treated in an integrated primary-care based behavioral health program?"
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile app | Experimental | Participants will install an app on their smartphone to add to their treatment for depression and/or anxiety. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| App for smartphone | Behavioral | A smartphone app will send psychoeducation and reminders to patients to complete self-report data, will collect passive data, and will provide aggregated information to a provider dashboard. |
| Measure | Description | Time Frame |
|---|---|---|
| App Acceptability as Measured by Number of Patient App Users Who Rate App Easy to Use and Time Spent Reasonable | The number of patients who rated the app was easy to use and the amount of time spent using the app as reasonable when asked about app acceptability in a qualitative interview and via a quantitative survey. Specific survey items included "The technology requires little effort to use," "The technology was easy to learn how to use," "The Ginger.io app is easy to use," and "The time required to answer questions in the Ginger.io app is reasonable." All patients who expressed agreement ("Somewhat Agree," "Agree," or "Strongly Agree") to these items and to similar questions in the qualitative interview were included in the count of patients who found the app acceptable. | Four weeks after intervention started |
| App Acceptability as Measured by Number of Care Manager Dashboard Users Who Rate Dashboard Easy to Use and Time Spent Reasonable | The number of care managers who agreed that the app dashboard was easy to use and that the amount of time spent using the app dashboard was reasonable when asked about app acceptability and benefit vs. burden of use with regard to clinical workflow in a qualitative interview. | 8-16 weeks after final patient participant is enrolled |
| App Usefulness as Measured by Number of Patient App Users Who Rate App as Useful | The number of patients who rated the app as useful to them when asked about app usefulness in a qualitative interview and via a quantitative survey. Specific survey items included "This technology is useful." All patients who expressed agreement ("Somewhat Agree," "Agree," or "Strongly Agree") to this items and to similar questions in the qualitative interview were included in the count of patients who found the app acceptable. | Four weeks after intervention started |
| App Usefulness as Measured by Number of Care Manager Dashboard Users Who Rate Dashboard as Useful | The number of care managers who expressed that the app was useful to them with regard to clinical workflow in a qualitative interview. |
| Measure | Description | Time Frame |
|---|---|---|
| Technology Acceptability as Measured by the Obtrusiveness Scale for Pervasive Technology (Modified) | The mean total of patient app users' responses to the modified version of the Obtrusiveness Scale for Pervasive Technology, with a mean score of 13-39 indicating that the app is generally perceived as unacceptable/obtrusive, 40-64 indicating neutrality, and 65-91 indicating that the app is generally perceived as acceptable/unobtrusive. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy M Bauer, MD, MS | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington Neighborhood Clinic, Ravenna | Seattle | Washington | 98105 | United States |
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Participants were recruited from the caseload of a care manager at the UW Ravenna Neighborhood Clinic who were enrolled in the Behavioral Health Integration Program for depression and anxiety. Recruitment letters were mailed between 6/15/2015 and 7/27/2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patient Mobile App Users | Participants installed an app on their smartphone to add to their treatment for depression and/or anxiety. This smartphone app sent psychoeducation and reminders to patients to complete self-report data, collected passive data, and provided aggregated information to a provider dashboard. Participants used the app for at least 4 weeks, with the option to continue use for up to 12 weeks. After 4 weeks, the research coordinator conducted a phone interview on satisfaction with the app. |
| FG001 | Care Manager Dashboard User | The care manager for the patients participating in this study used an online dashboard to monitor patient usage and responses to mobile app assessments (such as the PHQ-9) as part of her clinical workflow. She used this dashboard for the duration of participant involvement in the study (from 6/25/2015 through 9/30/2015). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient Mobile App Users | Participants installed an app for smartphone to add to their treatment for depression and/or anxiety. This smartphone app sent psychoeducation and reminders to patients to complete self-report data, collected passive data, and provided aggregated information to a provider dashboard. Participants used the app for at least 4 weeks, with the option to continue use for up to 12 weeks. After 4 weeks, the research coordinator conducted a phone interview on satisfaction with the app. |
| 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 | App Acceptability as Measured by Number of Patient App Users Who Rate App Easy to Use and Time Spent Reasonable | The number of patients who rated the app was easy to use and the amount of time spent using the app as reasonable when asked about app acceptability in a qualitative interview and via a quantitative survey. Specific survey items included "The technology requires little effort to use," "The technology was easy to learn how to use," "The Ginger.io app is easy to use," and "The time required to answer questions in the Ginger.io app is reasonable." All patients who expressed agreement ("Somewhat Agree," "Agree," or "Strongly Agree") to these items and to similar questions in the qualitative interview were included in the count of patients who found the app acceptable. | Overall Number of Participants Analyzed (16) is not consistent with numbers provided in the Participant Flow model (17) because one participant did not complete the quantitative survey used in this analysis. | Posted | Count of Participants | Participants | Four weeks after intervention started |
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Adverse event data was collected for the duration of participant involvement in the study (from 6/25/2015 through 9/30/2015).
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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 | Patient Mobile App Users | Participants installed an app for smartphone to add to their treatment for depression and/or anxiety. This smartphone app sent psychoeducation and reminders to patients to complete self-report data, collected passive data, and provided aggregated information to a provider dashboard. Participants used the app for at least 4 weeks, with the option to continue use for up to 12 weeks. After 4 weeks, the research coordinator conducted a phone interview on satisfaction with the app. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amy Bauer | University of Washington | 206.221.8385 | abauer1@uw.edu |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000682 | Amyloid |
| ID | Term |
|---|---|
| D046912 | Multiprotein Complexes |
| D046911 | Macromolecular Substances |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| smartphone | Device |
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| 8-16 weeks after final patient participant is enrolled |
| During weeks 3 and 8 |
| Patient Satisfaction as Measured by the Ginger.io Product Feedback Survey. | The mean total of patient app users' responses to the Ginger.io product feedback survey, with a mean score of 7-21 indicating satisfaction with the app, 22-34 neutrality, and 35-49 expressing dissatisfaction. | Days 30, 56 |
| Patient Use of the App as Measured by Percentage of App Surveys Completed. | The mean percentage of surveys presented to users through the app that were completed by patient app users in their first 8 weeks of using the app. App survey questions included weekly PHQ-9 and GAD-7 scales and daily measures of mood and medication use as well as satisfaction surveys. | Eight weeks after intervention started |
| Care Team Communication as Measured by the Consumer Assessment of Healthcare Providers and Systems (CAHPS) - Communication Scale | The mean total of patient app users' responses to the 6 items in the Consumer Assessment of Healthcare Providers and Systems (CAHPS) - Communication scale, with a mean score of 0-5 indicating that participants never or almost never experienced good communication with their care team, 6-11 indicating that participants sometimes experienced good communication with their care team, 12-17 indicating that patients usually experienced good communication with their care teams, and a score of 24 indicating that patients always experienced good communication with their care team. | Weeks 4 and 8 |
| Care Process Measures as Measured by the Number and Type of Contacts With Care Manager. | The mean number of Follow-Up contacts between patient and care manager during the 8 weeks following the patient's activation of the app. (Other types of contacts with the care manager include Initial Assessment and Contact Attempt, but neither of these occurred during the time frame of app use.) | Eight weeks after intervention started |
| BG001 | Care Manager Dashboard User | The care manager for the patients participating in this study used an online dashboard to monitor patient usage and responses to mobile app assessments (such as the PHQ-9) as part of her clinical workflow. She used this dashboard for the duration of participant involvement in the study (from 6/25/2015 through 9/30/2015). |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Employment Status | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| OG000 | Patient Mobile App Users | Participants installed an app for smartphone to add to their treatment for depression and/or anxiety. This smartphone app sent psychoeducation and reminders to patients to complete self-report data, collected passive data, and provided aggregated information to a provider dashboard. Participants used the app for at least 4 weeks, with the option to continue use for up to 12 weeks. After 4 weeks, the research coordinator conducted a phone interview on satisfaction with the app. |
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| Primary | App Acceptability as Measured by Number of Care Manager Dashboard Users Who Rate Dashboard Easy to Use and Time Spent Reasonable | The number of care managers who agreed that the app dashboard was easy to use and that the amount of time spent using the app dashboard was reasonable when asked about app acceptability and benefit vs. burden of use with regard to clinical workflow in a qualitative interview. | Posted | Count of Participants | Participants | 8-16 weeks after final patient participant is enrolled |
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| Primary | App Usefulness as Measured by Number of Patient App Users Who Rate App as Useful | The number of patients who rated the app as useful to them when asked about app usefulness in a qualitative interview and via a quantitative survey. Specific survey items included "This technology is useful." All patients who expressed agreement ("Somewhat Agree," "Agree," or "Strongly Agree") to this items and to similar questions in the qualitative interview were included in the count of patients who found the app acceptable. | Overall Number of Participants Analyzed (16) is not consistent with numbers provided in the Participant Flow model (17) because one participant did not complete the quantitative survey used in this analysis. | Posted | Count of Participants | Participants | Four weeks after intervention started |
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| Primary | App Usefulness as Measured by Number of Care Manager Dashboard Users Who Rate Dashboard as Useful | The number of care managers who expressed that the app was useful to them with regard to clinical workflow in a qualitative interview. | Posted | Count of Participants | Participants | 8-16 weeks after final patient participant is enrolled |
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| Secondary | Technology Acceptability as Measured by the Obtrusiveness Scale for Pervasive Technology (Modified) | The mean total of patient app users' responses to the modified version of the Obtrusiveness Scale for Pervasive Technology, with a mean score of 13-39 indicating that the app is generally perceived as unacceptable/obtrusive, 40-64 indicating neutrality, and 65-91 indicating that the app is generally perceived as acceptable/unobtrusive. | Only 3 participants were analyzed at the 8 week point because only 3 participants of the 17 completed the Week 8 survey. | Posted | Mean | Full Range | units on a scale | During weeks 3 and 8 |
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| Secondary | Patient Satisfaction as Measured by the Ginger.io Product Feedback Survey. | The mean total of patient app users' responses to the Ginger.io product feedback survey, with a mean score of 7-21 indicating satisfaction with the app, 22-34 neutrality, and 35-49 expressing dissatisfaction. | Overall Number of Participants Analyzed (13) is not consistent with numbers provided in the Participant Flow model (17) because 4 of the participants did not complete the Day 30 or the Day 56 survey. Only 2 participants were analyzed at the 56 day point because only 2 participants completed the Day 56 survey. | Posted | Mean | Full Range | units on a scale | Days 30, 56 |
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| Secondary | Patient Use of the App as Measured by Percentage of App Surveys Completed. | The mean percentage of surveys presented to users through the app that were completed by patient app users in their first 8 weeks of using the app. App survey questions included weekly PHQ-9 and GAD-7 scales and daily measures of mood and medication use as well as satisfaction surveys. | Posted | Mean | Full Range | Percentage of surveys completed | Eight weeks after intervention started |
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| Secondary | Care Team Communication as Measured by the Consumer Assessment of Healthcare Providers and Systems (CAHPS) - Communication Scale | The mean total of patient app users' responses to the 6 items in the Consumer Assessment of Healthcare Providers and Systems (CAHPS) - Communication scale, with a mean score of 0-5 indicating that participants never or almost never experienced good communication with their care team, 6-11 indicating that participants sometimes experienced good communication with their care team, 12-17 indicating that patients usually experienced good communication with their care teams, and a score of 24 indicating that patients always experienced good communication with their care team. | Only 13 participants were analyzed at the 8 week point because only 13 participants of the 17 completed the Week 8 survey. | Posted | Mean | Full Range | units on a scale | Weeks 4 and 8 |
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| Secondary | Care Process Measures as Measured by the Number and Type of Contacts With Care Manager. | The mean number of Follow-Up contacts between patient and care manager during the 8 weeks following the patient's activation of the app. (Other types of contacts with the care manager include Initial Assessment and Contact Attempt, but neither of these occurred during the time frame of app use.) | Posted | Mean | Full Range | number of contacts | Eight weeks after intervention started |
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| 0 |
| 18 |
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| 18 |
| 0 |
| 18 |
| EG001 | Care Manager Dashboard User | The care manager for the patients participating in this study used an online dashboard to monitor patient usage and responses to mobile app assessments (such as the PHQ-9) as part of her clinical workflow. She used this dashboard for the duration of participant involvement in the study (from 6/25/2015 through 9/30/2015). | 0 | 1 | 0 | 1 | 0 | 1 |
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