Boston Medical Center
Boston, Massachusetts, 02118, United States
NCT Number: NCT02965651
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.
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Notify Me18 year–50 year
Female
Interventional
Not applicable
Boston, Massachusetts, 02118, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 1 year
Time frame: 1 month
Time frame: 1 month
Time frame: 1 month
Time frame: 1 month
Likert scale of 1-7 (1=not satisfied, 7=very satisfied)
Time frame: 1 month
Time frame: 1 month
Time frame: 1 month
Time frame: 1 month
Time frame: 1 month
Time frame: 1 month
Time frame: 1 month
Height (ft) and weight (lbs)
Time frame: 1 month
Self-reported; cross-checked with medical records
Time frame: 1 month
Self-reported; cross-checked with medical records
Time frame: 1 month
Time frame: 1 month
Pain scale of 0-10 (0=no pain, 10=worst possible pain)
Time frame: 1 month
Patient Health Questionnaire - 9 items
Time frame: 1 month
Perceived Stress Scale - 4 items
Time frame: 1 month
Nutrition Survey
Time frame: 1 month
Household Food Insecurity Access Scale
Time frame: 1 month
Stanford Patient Education Research Center Exercise Behaviors
Time frame: 1 month
Intervention users only
Time frame: 1 month
Intervention users only (minutes)
Time frame: 1 month
Intervention users only
Boston Medical Center
Other
A Randomized Controlled Trial of A Virtual Patient Advocate System: "Go to Gabby" for Health and Wellness Information
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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