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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02497755
• Other study ID #: 47871
• Status: Completed
• Phase: N/A
• First received: February 14, 2015
• Last updated: October 25, 2017
• Start date: July 2015
• Est. completion date: October 2015

Study information

• Verified date: October 2017
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?"

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder

Intervention

Behavioral:
• App 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.

Device:
• smartphone

Locations

Country	Name	City	State
United States	University of Washington Neighborhood Clinic, Ravenna	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Four weeks after intervention started
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.	8-16 weeks after final patient participant is enrolled
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.	Four weeks after intervention started
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.	8-16 weeks after final patient participant is enrolled
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.	During weeks 3 and 8
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.	Days 30, 56
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.	Eight weeks after intervention started
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.	Weeks 4 and 8
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.)	Eight weeks after intervention started