Anxiety, Depression
Conditions
Brief summary
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.
Detailed description
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?
Interventions
BEHAVIORALApp for smartphone
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.
DEVICEsmartphone
Sponsors
University of Washington
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Be part of the Behavioral Health Integration Program for anxiety and/or depression; Must have an iPhone or Android smartphone with a mobile voice calling plan with a US carrier; Fluent in English
Exclusion criteria
* Individual unable or unwilling to accept the terms of the Ginger.io terms of Use; Actively suicidal as determined by a healthcare professional; score of 3 on the Patient Health Questionnaire-9 item 9 (which assesses thoughts of self-harm); or documented history of 2 or more prior suicide attempts; Working diagnosis of psychotic disorder, bipolar disorder, dementia, active substance dependence
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| App Acceptability as Measured by Number of Patient App Users Who Rate App Easy to Use and Time Spent Reasonable | Four weeks after intervention started | 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. |
| App Acceptability as Measured by Number of Care Manager Dashboard Users Who Rate Dashboard Easy to Use and Time Spent Reasonable | 8-16 weeks after final patient participant is enrolled | 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. |
| App Usefulness as Measured by Number of Patient App Users Who Rate App as Useful | Four weeks after intervention started | 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. |
| App Usefulness as Measured by Number of Care Manager Dashboard Users Who Rate Dashboard as Useful | 8-16 weeks after final patient participant is enrolled | The number of care managers who expressed that the app was useful to them with regard to clinical workflow in a qualitative interview. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Care Process Measures as Measured by the Number and Type of Contacts With Care Manager. | Eight weeks after intervention started | 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.) |
| Care Team Communication as Measured by the Consumer Assessment of Healthcare Providers and Systems (CAHPS) - Communication Scale | Weeks 4 and 8 | 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. |
| Technology Acceptability as Measured by the Obtrusiveness Scale for Pervasive Technology (Modified) | During weeks 3 and 8 | 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. |
| Patient Satisfaction as Measured by the Ginger.io Product Feedback Survey. | Days 30, 56 | 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. |
| Patient Use of the App as Measured by Percentage of App Surveys Completed. | Eight weeks after intervention started | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 17 |
| 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). | 1 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Patient Mobile App Users | Care Manager Dashboard User |
|---|---|---|---|
| Age, Categorical <=18 years | NA Participants | 0 Participants | NA Participants |
| Age, Categorical >=65 years | NA Participants | 1 Participants | NA Participants |
| Age, Categorical Between 18 and 65 years | NA Participants | 16 Participants | NA Participants |
| Education Bachelor's degree | NA Participants | 10 Participants | NA Participants |
| Education Graduate or professional degree | NA Participants | 3 Participants | NA Participants |
| Education High school/GED | NA Participants | 1 Participants | NA Participants |
| Education Some college | NA Participants | 3 Participants | NA Participants |
| Employment Status Full time paid employment | NA Participants | 11 Participants | NA Participants |
| Employment Status Not working by choice | NA Participants | 1 Participants | NA Participants |
| Employment Status Student | NA Participants | 3 Participants | NA Participants |
| Employment Status Unable to work | NA Participants | 2 Participants | NA Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | NA Participants | 0 Participants | NA Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | NA Participants | 17 Participants | NA Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | NA Participants | 0 Participants | NA Participants |
| Race (NIH/OMB) American Indian or Alaska Native | NA Participants | 0 Participants | NA Participants |
| Race (NIH/OMB) Asian | NA Participants | 0 Participants | NA Participants |
| Race (NIH/OMB) Black or African American | NA Participants | 1 Participants | NA Participants |
| Race (NIH/OMB) More than one race | NA Participants | 0 Participants | NA Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | NA Participants | 0 Participants | NA Participants |
| Race (NIH/OMB) Unknown or Not Reported | NA Participants | 0 Participants | NA Participants |
| Race (NIH/OMB) White | NA Participants | 16 Participants | NA Participants |
| Region of Enrollment United States | 18 participants | 17 participants | 1 participants |
| Sex: Female, Male Female | NA Participants | 10 Participants | NA Participants |
| Sex: Female, Male Male | NA Participants | 7 Participants | NA Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 1 |
| other Total, other adverse events | 0 / 18 | 0 / 1 |
| serious Total, serious adverse events | 0 / 18 | 0 / 1 |
Outcome results
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.
Time frame: 8-16 weeks after final patient participant is enrolled
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patient Mobile App Users | App Acceptability as Measured by Number of Care Manager Dashboard Users Who Rate Dashboard Easy to Use and Time Spent Reasonable | 1 Participants |
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.
Time frame: Four weeks after intervention started
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patient Mobile App Users | App Acceptability as Measured by Number of Patient App Users Who Rate App Easy to Use and Time Spent Reasonable | 16 Participants |
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.
Time frame: 8-16 weeks after final patient participant is enrolled
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patient Mobile App Users | App Usefulness as Measured by Number of Care Manager Dashboard Users Who Rate Dashboard as Useful | 1 Participants |
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.
Time frame: Four weeks after intervention started
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patient Mobile App Users | App Usefulness as Measured by Number of Patient App Users Who Rate App as Useful | 11 Participants |
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.)
Time frame: Eight weeks after intervention started
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Patient Mobile App Users | Care Process Measures as Measured by the Number and Type of Contacts With Care Manager. | 1.35 number of contacts |
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.
Time frame: Weeks 4 and 8
Population: Only 13 participants were analyzed at the 8 week point because only 13 participants of the 17 completed the Week 8 survey.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Patient Mobile App Users | Care Team Communication as Measured by the Consumer Assessment of Healthcare Providers and Systems (CAHPS) - Communication Scale | Week 4 | 17 units on a scale |
| Patient Mobile App Users | Care Team Communication as Measured by the Consumer Assessment of Healthcare Providers and Systems (CAHPS) - Communication Scale | Week 8 | 16 units on a scale |
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.
Time frame: Days 30, 56
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Patient Mobile App Users | Patient Satisfaction as Measured by the Ginger.io Product Feedback Survey. | Day 30 | 19.85 units on a scale |
| Patient Mobile App Users | Patient Satisfaction as Measured by the Ginger.io Product Feedback Survey. | Day 56 | 13.00 units on a scale |
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.
Time frame: Eight weeks after intervention started
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Patient Mobile App Users | Patient Use of the App as Measured by Percentage of App Surveys Completed. | 60.24 Percentage of surveys completed |
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.
Time frame: During weeks 3 and 8
Population: Only 3 participants were analyzed at the 8 week point because only 3 participants of the 17 completed the Week 8 survey.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Patient Mobile App Users | Technology Acceptability as Measured by the Obtrusiveness Scale for Pervasive Technology (Modified) | Week 3 | 69.06 units on a scale |
| Patient Mobile App Users | Technology Acceptability as Measured by the Obtrusiveness Scale for Pervasive Technology (Modified) | Week 8 | 80.33 units on a scale |