Clinical trial NCT02965651: Engaging Women With the Gabby System to Deliver Multiple Health-Related Behavioral Changes: A Feasibility Study
Official title: A Randomized Controlled Trial of A Virtual Patient Advocate System: "Go to Gabby" for Health and Wellness Information
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Emotional
Keywords: embodied conversational agent
virtual patient agent
meditation
mindfulness based stress reduction
nutrition
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2016-11-17
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of people recruited
timeFrame: 1 year
measure: Number of participants who completed the study
timeFrame: 1 month
measure: Number of participants whom outcome data can be collected
timeFrame: 1 month
measure: Number of participants who were racial minorities (non-white)
timeFrame: 1 month
measure: Participant satisfaction with either treatment arm
timeFrame: 1 month
Secondary outcomes:
measure: Age
timeFrame: 1 month
measure: Race
timeFrame: 1 month
measure: Ethnicity
timeFrame: 1 month
measure: Education Level
timeFrame: 1 month
measure: Work Status
timeFrame: 1 month
measure: Income Level
timeFrame: 1 month
measure: BMI
timeFrame: 1 month
measure: Health Conditions
timeFrame: 1 month
measure: Medication Use
timeFrame: 1 month
measure: Smoking Status
timeFrame: 1 month
measure: Pain Levels
timeFrame: 1 month
measure: Depression
timeFrame: 1 month
measure: Stress Level
timeFrame: 1 month
measure: Dietary Patterns
timeFrame: 1 month
measure: Food Access
timeFrame: 1 month
measure: Physical Activity
timeFrame: 1 month
measure: Number of Logins into the ECA
timeFrame: 1 month
measure: Duration of ECA Use
timeFrame: 1 month
measure: Technical issues
timeFrame: 1 month
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Paula Gardiner, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.