Clinical trial NCT02497755: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2015-07-14
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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?"

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

Primary outcomes:
measure: App Acceptability as Measured by Number of Patient App Users Who Rate App Easy to Use and Time Spent Reasonable
timeFrame: Four weeks after intervention started
measure: App Acceptability as Measured by Number of Care Manager Dashboard Users Who Rate Dashboard Easy to Use and Time Spent Reasonable
timeFrame: 8-16 weeks after final patient participant is enrolled
measure: App Usefulness as Measured by Number of Patient App Users Who Rate App as Useful
timeFrame: Four weeks after intervention started
measure: App Usefulness as Measured by Number of Care Manager Dashboard Users Who Rate Dashboard as Useful
timeFrame: 8-16 weeks after final patient participant is enrolled
Secondary outcomes:
measure: Technology Acceptability as Measured by the Obtrusiveness Scale for Pervasive Technology (Modified)
timeFrame: During weeks 3 and 8
measure: Patient Satisfaction as Measured by the Ginger.io Product Feedback Survey.
timeFrame: Days 30, 56
measure: Patient Use of the App as Measured by Percentage of App Surveys Completed.
timeFrame: Eight weeks after intervention started
measure: Care Team Communication as Measured by the Consumer Assessment of Healthcare Providers and Systems (CAHPS) - Communication Scale
timeFrame: Weeks 4 and 8
measure: Care Process Measures as Measured by the Number and Type of Contacts With Care Manager.
timeFrame: Eight weeks after intervention started
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Neighborhood Clinic, Ravenna
state: Washington
Study officials:
affiliation: University of Washington
name: Amy M Bauer, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: