Connection to Care: Pilot Study of a Mobile Health Tool for Patients With Depression and Anxiety

Study Overview
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Brief Summary
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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.

Detailed Description
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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?

Official Title
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Connection to Care: Pilot Study of a Mobile Health Tool for Patients With Depression and Anxiety

Conditions
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Anxiety, Depression

Intervention / Treatment
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* Behavioral: App for smartphone
* Device: smartphone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile app<br>Participants will install an app on their smartphone to add to their treatment for depression and/or anxiety. | Behavioral: App for smartphone<br>* 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.<br>Device: smartphone<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 8-16 weeks after final patient participant is enrolled | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |