Back to resultsConnection to Care: Pilot Study of a Mobile Health Tool for Patients With Depression and Anxiety
Primary Purpose
Anxiety, Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
App for smartphone
smartphone
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety
Eligibility Criteria
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
Sites / Locations
- University of Washington Neighborhood Clinic, Ravenna
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mobile app
Arm Description
Participants will install an app on their smartphone to add to their treatment for depression and/or anxiety.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.)
Full Information
NCT ID
NCT02497755
First Posted
February 14, 2015
Last Updated
October 25, 2017
Sponsor
University of Washington
1. Study Identification
Unique Protocol Identification Number
NCT02497755
Brief Title
Connection to Care: Pilot Study of a Mobile Health Tool for Patients With Depression and Anxiety
Official Title
Connection to Care: Pilot Study of a Mobile Health Tool for Patients With Depression and Anxiety
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
4. Oversight
Data Monitoring Committee
No
5. Study Description
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?"
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mobile app
Arm Type
Experimental
Arm Description
Participants will install an app on their smartphone to add to their treatment for depression and/or anxiety.
Intervention Type
Behavioral
Intervention Name(s)
App for smartphone
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
smartphone
Primary Outcome Measure Information:
Title
App Acceptability as Measured by Number of Patient App Users Who Rate App Easy to Use and Time Spent Reasonable
Description
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
Title
App Acceptability as Measured by Number of Care Manager Dashboard Users Who Rate Dashboard Easy to Use and Time Spent Reasonable
Description
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
Title
App Usefulness as Measured by Number of Patient App Users Who Rate App as Useful
Description
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
Title
App Usefulness as Measured by Number of Care Manager Dashboard Users Who Rate Dashboard as Useful
Description
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
Secondary Outcome Measure Information:
Title
Technology Acceptability as Measured by the Obtrusiveness Scale for Pervasive Technology (Modified)
Description
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
Title
Patient Satisfaction as Measured by the Ginger.io Product Feedback Survey.
Description
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
Title
Patient Use of the App as Measured by Percentage of App Surveys Completed.
Description
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
Title
Care Team Communication as Measured by the Consumer Assessment of Healthcare Providers and Systems (CAHPS) - Communication Scale
Description
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
Title
Care Process Measures as Measured by the Number and Type of Contacts With Care Manager.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy M Bauer, MD, MS
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington Neighborhood Clinic, Ravenna
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Connection to Care: Pilot Study of a Mobile Health Tool for Patients With Depression and Anxiety
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