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临床试验/NCT02491307
NCT02491307终止不适用

Ginger.io Behavioral Health Study

Community Health Center, Inc.8 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2015年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
10
试验地点
8
主要终点
Service Utilization

研究概览

简要总结

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.

详细描述

Procedures involved in the Human Research Overview: The investigators will use a quasi-experimental study with a pre-post intervention design to evaluate the usability, feasibility, acceptability, and potential utility of a smartphone app to improve patient-behavioral health provider communication and care for patients with mood disorders (e.g. depression, anxiety, bipolar). The smartphone app will collect patient smartphone interaction data and survey data from patients on their health and functioning including mood, depression, and anxiety levels. At various points during the study, patients will be surveyed about their experience using the smartphone application, Ginger.io.

All behavioral health providers at Community Health Center, Inc. (CHCI) who are using the app with their patients will be granted access to a secured, password-protected, web-based dashboard that will collect and display information related to patients' health and behavior. The research assistant and behavioral health providers will use the web-based dashboard to monitor patient activation and survey completion, and the behavioral health provider will use it to proactively reach out to patients and aid in discussions with the patient about the care he/she receives at CHCI. At various points during the study, behavioral health providers will be surveyed about their experience using the secured, password-protected web-based provider dashboard.

Behavioral health providers at multiple CHCI sites will be using this app with their patients as part of their care. From the pool of Ginger.io existing users, about 500 patients will sign written informed consent and join the research study. These patients will provide survey information that will be used in the research study. Comparison data will also be gathered from CHCI's electronic health record and via the completion of paper surveys for approximately 100 patients that sign written informed consent and who are receiving routine behavioral health care at CHCI but are not using the Ginger.io app. Baseline data on the patient's depression, bipolar and anxiety will be collected the first time using the Ginger.io app or filling out paper forms in control clinics.

Intervention patients will be asked to use the Ginger.io smartphone app for a minimum of 6 months, to answer depression, anxiety and mood questions. The Ginger.io app may also be used by patients on a less frequent (e.g. weekly, biweekly, or monthly) basis to answer more detailed surveys like the self-report hospitalization or Patient Health Questionnaire (PHQ-9), which collects data on depression. These daily and weekly assessments of patient mood, depression and anxiety, including data on the patient's mobility and communication, will be collected by the Ginger.io smartphone application, and available 24/7 in the dashboard, so that the dashboard monitor can take appropriate action (or should they choose, the behavioral health clinician could view as well at monthly visits). Most importantly, behavioral health providers will be performing proactive outreach to patients that are identified by alerts as being at higher likelihood of mood disorder irregularities. These alerts are powered by patient survey responses and smartphone passive behavioral changes.

Intervention Description:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 未提供

结局指标

主要结局

Service Utilization

时间窗: 6 months

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

Emergecny room and hospitalization Data

时间窗: 6 months

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

次要结局

  • Behavioral Health provider satisfaction(6 months)
  • Behavioral health provider effectiveness score(6 months)
  • Patient perceived mental health status(6 months)
  • Patient satisfaction/connectedness(6 months)
  • Progress towards treatment goals(6 months)
  • Patient activation/self-management(6 months)
  • Patient perceived physical health status(6 months)

研究者

发起方
Community Health Center, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (8)

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