Ginger.io Behavioral Health Study

NCT02491307 | Terminated

• 1 other identifier: 1059
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 4

Brief Summary

This Study will evaluate the impact of a smartphone-based platform on a range of outcomes for medically-underserved patients with mood disorders (e.g. depression, anxiety, bipolar) cared for in a large statewide community health center. The primary goal of the Study is to reduce emergency room (ER) visits, hospitalizations, and to look at changes in service utilization by using the Ginger.io platform to enhance communication between behavioral health providers and their patients, increasing the early detection of exacerbations in mood disorders (e.g. depression, anxiety, bipolar) and proactive outreach. The secondary goal is to improve clinical \& behavioral health outcomes.

Conditions

Anxiety; Depression; Bipolar I Disorder; Bipolar II Disorder

Outcome Measures

Primary Outcomes (2)

• Emergecny room and hospitalization Data

  Data on hospitalizations and ER visits will be collected for each enrolled patient over a 6 month time frame through an in-app question and/or as recorded in the patient's EHR

  6 months

• Service Utilization

  Data on visits to CHCI during the patient's 6 month enrollment will be extracted from the EHR and examined for volume and type.

  6 months

Secondary Outcomes (7)

• Patient activation/self-management

  6 months

• Patient perceived physical health status

  6 months

• Patient perceived mental health status

  6 months

• Patient satisfaction/connectedness

  6 months

• Behavioral Health provider satisfaction

  6 months

Study Arms (2)

Ginger.io Application Users

EXPERIMENTAL

This cohort is comprised of individuals that 1) are English-speaking; 2) possess an Android or iOS smartphone; 3) have a diagnosis for anxiety, depression, and/or bipolar disorder; and 4) are active behavioral health patients at any of the four CHCI clinic sites (New London, New Britain, Middletown, or Meriden) where behavioral health providers are using the Ginger.io app with their patients. These patients receive the Ginger.io smartphone application for daily use.

Other: Ginger.io Smartphone Application

Non-application users

NO INTERVENTION

This cohort is comprised of individuals that 1) are English-speaking; 2) possess an Android or iOS smartphone; 3) have anxiety, depression, and/or bipolar disorder; and 4) are patient of a behavioral health clinician that is providing paper surveys to patients in clinic. They do not receive the Ginger.io smartphone application.

Interventions

Ginger.io Smartphone Application OTHER

Daily use of the Ginger.io smartphone application

Ginger.io Application Users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Experiencing mood disorders (e.g. depression, anxiety, bipolar) defined as a visit with a specified DSM-V code (295.7 Schizoaffective Disorder (Depressive type), 295.7 Schizoaffective Disorder (Bipolar type), 296.41 Bipolar I Current or most recent episode manic Mild, 296.42 Bipolar I Current or most recent episode manic mod, 296.43 Bipolar I Current or most recent episode manic sev, 296.44 Bipolar I Current or most recent episode manic w psychotic, 296.45 Bipolar I Current or most recent episode manic in partial remission, 296.46 Bipolar I Current or most recent episode manic in full remission, 296.40 Bipolar I Current or most recent episode unspecified, 296.40 Bipolar I Current or most recent episode hypomanic, 296.45 Bipolar I Current or most recent episode hypomanic in partial remission, 296.46 Bipolar I Current or most recent episode hypomanic in full remission, 296.40 Bipolar I Current or most recent episode hypomanic unspecified, 296.51Bipolar 1 Current or most recent episode depressed mild, 296.52 Bipolar 1 Current or most recent episode depressed mod, 296.53 Bipolar 1 Current or most recent episode depressed sev, 296.54 Bipolar 1 Current or most recent episode depressed w psychotic, 296.55 Bipolar 1 Current or most recent episode depressed in partial remission, 296.56 Bipolar 1 Current or most recent episode depressed in full remission, 296.50 Bipolar 1 Current or most recent episode depressed unspecified, 296.7 Bipolar 1 current or most recent episode unspecified, 296.89 Bipolar II, 301.13 Cyclothymic, 296.83 Bipolar due to Medical Condition, 296.89 Other Specified Bipolar, 296.80 Unspecified Bipolar, 296.99 Disruptive Mood Dysregulation disorder, 296.21 Major Depressive Disorder Single Episode Mild, 296.22 Major Depressive Disorder Single Episode mod, 296.23 Major Depressive Disorder Single Episode sev, 296.24 Major Depressive Disorder Single Episode w psychotic, 296.25 Major Depressive Disorder Single Episode in partial remission, 296.26 Major Depressive Disorder Single Episode in full remission, 296.20 Major Depressive Disorder Single Episode unspecified, 296.31 Major Depressive Disorder Recurrent Episode mild, 296.32 Major Depressive Disorder Recurrent Episode moderate, 296.33 Major Depressive Disorder Recurrent Episode severe, 296.34 Major Depressive Disorder Recurrent Episode w psychotic, 296.35 Major Depressive Disorder Recurrent Episode in partial remission, 296.36 Major Depressive Disorder Recurrent Episode in full remission, 296.30 unspecified, 300.4 Persistent Depressive Disorder (Dysthymia), 625.4 Premenstrual Dysphoric Disorder, 293.83 Depressive Disorder due to another medical condition, 311 Other specified depressive disorder, 311 Unspecified Depressive disorder, 309.21 Separation anxiety disorder, 300.29 Specific Phobia, 300.23 Social anxiety do, 300.01 Panic Disorder, 300.22 Agoraphobia, 300.02 GAD, 293.84 Anxiety do due to another med condition, 300.09 other specified anxiety do, 300.00 Uspecified Anxiety do, 309.0 Adjustment do with depressed mood, 309.24 Adjustment do with anxiety, 309.28 Adjustment do with mixed, 309.4 Adjustment do with w disturbance of emotions and conduct, 309.9 Adjustment do unspecified, 300.7 Illness anxiety disorder, 293.83 Mood do NOS, 296.9 Mood do unspecified, 291.89 alcohol inducted mood do, 292.84 amphetamine inducted mood do 292.84 cocaine inducted mood do, unspecified inducted mood do, 296.66 episodic mood dis unspecified, 296.64 Severe mixed bipolar do)
• Possessing a smartphone with either an Android or iOS platform
• Able to read and write in English
• Have a designated primary behavioral health care provider who is either using the app with their patients (intervention) or is issuing the surveys on paper in their clinic (control)

You may not qualify if:

• None

Sponsors & Collaborators

• Community Health Center, Inc.: lead
• Ginger.io: collaborator
• Robert Wood Johnson Foundation: collaborator

Study Sites (4)

Community Health Center, Inc.-Meriden

Meriden, Connecticut, 06450, United States

Location

Community Health Center, Inc.- Middletown

Middletown, Connecticut, 06457, United States

Location

Community Health Center, Inc.-New Britain

New Britain, Connecticut, 06051, United States

Location

Community Health Center, Inc.-New London

New London, Connecticut, 06320, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression; Bipolar Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Bipolar and Related Disorders; Mood Disorders

Study Officials

• David Guggenheim, PsyD

  Community Health Center, Inc.

  PRINCIPAL INVESTIGATOR

• Ilan Elson, PhD

  Ginger.io

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2015
• First Posted: July 8, 2015
• Study Start: July 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: April 25, 2017

Record last verified: 2017-04

Locations

US (4)