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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
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.
Boston Medical Center
Boston, Massachusetts, United States
Number of people recruited
Time frame: 1 year
Number of participants who completed the study
Time frame: 1 month
Number of participants whom outcome data can be collected
Time frame: 1 month
Number of participants who were racial minorities (non-white)
Time frame: 1 month
Participant satisfaction with either treatment arm
Likert scale of 1-7 (1=not satisfied, 7=very satisfied)
Time frame: 1 month
Age
Time frame: 1 month
Race
Time frame: 1 month
Ethnicity
Time frame: 1 month
Education Level
Time frame: 1 month
Work Status
Time frame: 1 month
Income Level
Time frame: 1 month
BMI
Height (ft) and weight (lbs)
Time frame: 1 month
Health Conditions
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Self-reported; cross-checked with medical records
Time frame: 1 month
Medication Use
Self-reported; cross-checked with medical records
Time frame: 1 month
Smoking Status
Time frame: 1 month
Pain Levels
Pain scale of 0-10 (0=no pain, 10=worst possible pain)
Time frame: 1 month
Depression
Patient Health Questionnaire - 9 items
Time frame: 1 month
Stress Level
Perceived Stress Scale - 4 items
Time frame: 1 month
Dietary Patterns
Nutrition Survey
Time frame: 1 month
Food Access
Household Food Insecurity Access Scale
Time frame: 1 month
Physical Activity
Stanford Patient Education Research Center Exercise Behaviors
Time frame: 1 month
Number of Logins into the ECA
Intervention users only
Time frame: 1 month
Duration of ECA Use
Intervention users only (minutes)
Time frame: 1 month
Technical issues
Intervention users only
Time frame: 1 month