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

NCT02497755 | Completed Results

• 1 other identifier: 47871
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Depression

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Technology Acceptability as Measured by the Obtrusiveness Scale for Pervasive Technology (Modified)

  During weeks 3 and 8

• 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 Team Communication as Measured by the Consumer Assessment of Healthcare Providers and Systems (CAHPS) - Communication Scale

  Weeks 4 and 8

• Care Process Measures as Measured by the Number and Type of Contacts With Care Manager.

  Eight weeks after intervention started

Study Arms (1)

Mobile app

EXPERIMENTAL

Participants will install an app on their smartphone to add to their treatment for depression and/or anxiety.

Behavioral: App for smartphone; Device: smartphone

Interventions

App for smartphone BEHAVIORAL

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.

Mobile app

smartphone DEVICE

Mobile app

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington Neighborhood Clinic, Ravenna

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Amy Bauer
• Organization: University of Washington

abauer1@uw.edu

206.221.8385

Study Officials

• Amy M Bauer, MD, MS

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 14, 2015
• First Posted: July 14, 2015
• Study Start: July 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 2, 2017
• Results First Posted: December 2, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)