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

Stress, Emotional Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02965651
• Other study ID #: H-30418
• Status: Completed
• Phase: N/A
• First received: November 7, 2016
• Last updated: March 15, 2017
• Start date: January 2015
• Est. completion date: January 2016

Study information

• Verified date: March 2017
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Stress, Emotional
• Stress, Psychological

Intervention

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.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of people recruited		1 year
Primary	Number of participants who completed the study		1 month
Primary	Number of participants whom outcome data can be collected		1 month
Primary	Number of participants who were racial minorities (non-white)		1 month
Primary	Participant satisfaction with either treatment arm	Likert scale of 1-7 (1=not satisfied, 7=very satisfied)	1 month
Secondary	Age		1 month
Secondary	Race		1 month
Secondary	Ethnicity		1 month
Secondary	Education Level		1 month
Secondary	Work Status		1 month
Secondary	Income Level		1 month
Secondary	BMI	Height (ft) and weight (lbs)	1 month
Secondary	Health Conditions	Self-reported; cross-checked with medical records	1 month
Secondary	Medication Use	Self-reported; cross-checked with medical records	1 month
Secondary	Smoking Status		1 month
Secondary	Pain Levels	Pain scale of 0-10 (0=no pain, 10=worst possible pain)	1 month
Secondary	Depression	Patient Health Questionnaire - 9 items	1 month
Secondary	Stress Level	Perceived Stress Scale - 4 items	1 month
Secondary	Dietary Patterns	Nutrition Survey	1 month
Secondary	Food Access	Household Food Insecurity Access Scale	1 month
Secondary	Physical Activity	Stanford Patient Education Research Center Exercise Behaviors	1 month
Secondary	Number of Logins into the ECA	Intervention users only	1 month
Secondary	Duration of ECA Use	Intervention users only (minutes)	1 month
Secondary	Technical issues	Intervention users only	1 month