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Clinical Trials/NCT02497755
NCT02497755
Completed
Not Applicable

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

University of Washington1 site in 1 country18 target enrollmentJuly 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety
Sponsor
University of Washington
Enrollment
18
Locations
1
Primary Endpoint
App Acceptability as Measured by Number of Patient App Users Who Rate App Easy to Use and Time Spent Reasonable
Status
Completed
Last Updated
8 years ago

Overview

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?"

Registry
clinicaltrials.gov
Start Date
July 2015
End Date
October 2015
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amy Bauer

Assistant Professor

University of Washington

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

Outcomes

Primary Outcomes

App Acceptability as Measured by Number of Patient App Users Who Rate App Easy to Use and Time Spent Reasonable

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • Patient Satisfaction as Measured by the Ginger.io Product Feedback Survey.(Days 30, 56)
  • Patient Use of the App as Measured by Percentage of App Surveys Completed.(Eight weeks after intervention started)
  • Care Process Measures as Measured by the Number and Type of Contacts With Care Manager.(Eight weeks after intervention started)
  • Care Team Communication as Measured by the Consumer Assessment of Healthcare Providers and Systems (CAHPS) - Communication Scale(Weeks 4 and 8)
  • Technology Acceptability as Measured by the Obtrusiveness Scale for Pervasive Technology (Modified)(During weeks 3 and 8)

Study Sites (1)

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