Engaging Women With the Gabby System to Deliver Multiple Health-Related Behavioral Changes: A Feasibility Study

A Randomized Controlled Trial of A Virtual Patient Advocate System: "Go to Gabby" for Health and Wellness Information

The purpose of this randomized controlled trial is to evaluate the feasibility of introducing an innovative eHealth technology, the Embodied Conversational Agent (ECA), to diverse women from an urban outpatient setting.

Study Overview

• Status: Completed
• Conditions: Stress, Emotional
• Intervention / Treatment: Behavioral: ECA System

Detailed Description

This trial focuses on using an embodied conversational agent (ECA) named Gabby to teach healthy lifestyle behaviors (healthy eating, exercise, stress reduction). This feasibility randomized control trial will include 70 women in the outpatient setting (35 intervention and 35 controls). The control group will receive usual care (patient information sheets on healthy eating, exercise, stress reduction and a CD with meditation, body scan, and mindful yoga).

The ECA is an animated conversational character who simulates face-to-face interaction with a patient. During the intervention, the ECA talks using synthetic speech and synchronized animation; patients "talk" by clicking what they want to say using a computer's mouse. The ECA delivers information and experiential on stress (principles of mindfulness based stress reduction such as: meditation, yoga, body scan), nutrition, and exercise.

If participants are randomized to the intervention, a research assistant (RA) will teach the subject how to use the ECA workstation. The ECA will review with the patients their nutrition, stress, exercise, using the ECA workstation which will also be programmed with the subject's baseline information (e.g., name, age). Subjects will be asked to log onto the system once a day and interact with the system for as long as they wish.

Prior to the midpoint survey, participants will receive a reminder phone call/email. At 14 days, the RA will survey all participants regarding satisfaction with either the ECA or the paper handouts, and whether or not they are adhering to the lifestyle modification recommendations. This will be conducted either by email, phone or in person.

Prior to the end of the 30 day study participation, the RA will call or email to schedule a visit to complete the post intervention questionnaire. The RA will call/email 1-2 days before the final study visit to remind the participant.

The RA will conduct the post intervention interview in person or by phone. All participants received compensation for completion of surveys.

Control Group: The control subjects will receive usual care (patient information sheets on stress, nutrition and exercise and a CD). The RA will administer the same baseline, mid-point and final surveys to the control participants.

The investigators do not know, however, whether health information technology can be used effectively to deliver information on exercise, nutrition and stress in the outpatient setting. This study will add new information to the viability of using the ECA in women in the outpatient setting compared to patient information sheets.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• English fluency sufficient to follow treatment instructions and answer survey questions
• Access to a telephone (landline, cellular phone)
• Access to a computer/laptop with internet/Wi-Fi access

Exclusion Criteria:

• Known or planned pregnancy
• Mental health or substance abuse problems that would bar completion of study
• Refusal of consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ECA System; Access to website and virtual patient advocate	Behavioral: ECA System; The ECA system, named "Gabby", included content pertaining to stress management, nutrition and physical activity as well as dialogue scripts and media such as meditations. The scripts included motivational interviewing dialogue: dialogue to simulate shared decision making interactions and additional longitudinal interaction using techniques such as "goal setting," "problem solving," "tips," and "homework". Gabby was available on a web browser through a username and secure password login.
No Intervention: Standard of Care; Patient information sheets and meditation CD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of people recruited		1 year
Number of participants who completed the study		1 month
Number of participants whom outcome data can be collected		1 month
Number of participants who were racial minorities (non-white)		1 month
Participant satisfaction with either treatment arm	Likert scale of 1-7 (1=not satisfied, 7=very satisfied)	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age		1 month
Race		1 month
Ethnicity		1 month
Education Level		1 month
Work Status		1 month
Income Level		1 month
BMI	Height (ft) and weight (lbs)	1 month
Health Conditions	Self-reported; cross-checked with medical records	1 month
Medication Use	Self-reported; cross-checked with medical records	1 month
Smoking Status		1 month
Pain Levels	Pain scale of 0-10 (0=no pain, 10=worst possible pain)	1 month
Depression	Patient Health Questionnaire - 9 items	1 month
Stress Level	Perceived Stress Scale - 4 items	1 month
Dietary Patterns	Nutrition Survey	1 month
Food Access	Household Food Insecurity Access Scale	1 month
Physical Activity	Stanford Patient Education Research Center Exercise Behaviors	1 month
Number of Logins into the ECA	Intervention users only	1 month
Duration of ECA Use	Intervention users only (minutes)	1 month
Technical issues	Intervention users only	1 month

Collaborators and Investigators

• Sponsor: Boston Medical Center

Publications and helpful links

General Publications

• Gardiner P, Hempstead MB, Ring L, Bickmore T, Yinusa-Nyahkoon L, Tran H, Paasche-Orlow M, Damus K, Jack B. Reaching women through health information technology: the Gabby preconception care system. Am J Health Promot. 2013 Jan-Feb;27(3 Suppl):eS11-20. doi: 10.4278/ajhp.1200113-QUAN-18.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: November 7, 2016
• First Submitted That Met QC Criteria: November 14, 2016
• First Posted (Estimate): November 17, 2016

Study Record Updates

• Last Update Posted (Actual): March 16, 2017
• Last Update Submitted That Met QC Criteria: March 15, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: nutrition; meditation; mindfulness based stress reduction; embodied conversational agent; virtual patient agent
• Other Study ID Numbers: H-30418

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO