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Completed

NCT Number: NCT02965651

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

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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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ECA System

Behavioral

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.

Primary outcomes

  1. Number of people recruited

    Time frame: 1 year

  2. Number of participants who completed the study

    Time frame: 1 month

  3. Number of participants whom outcome data can be collected

    Time frame: 1 month

  4. Number of participants who were racial minorities (non-white)

    Time frame: 1 month

  5. Participant satisfaction with either treatment arm

    Time frame: 1 month

    Likert scale of 1-7 (1=not satisfied, 7=very satisfied)

Secondary outcomes

  1. Age

    Time frame: 1 month

  2. Race

    Time frame: 1 month

  3. Ethnicity

    Time frame: 1 month

  4. Education Level

    Time frame: 1 month

  5. Work Status

    Time frame: 1 month

  6. Income Level

    Time frame: 1 month

  7. BMI

    Time frame: 1 month

    Height (ft) and weight (lbs)

  8. Health Conditions

    Time frame: 1 month

    Self-reported; cross-checked with medical records

  9. Medication Use

    Time frame: 1 month

    Self-reported; cross-checked with medical records

  10. Smoking Status

    Time frame: 1 month

  11. Pain Levels

    Time frame: 1 month

    Pain scale of 0-10 (0=no pain, 10=worst possible pain)

  12. Depression

    Time frame: 1 month

    Patient Health Questionnaire - 9 items

  13. Stress Level

    Time frame: 1 month

    Perceived Stress Scale - 4 items

  14. Dietary Patterns

    Time frame: 1 month

    Nutrition Survey

  15. Food Access

    Time frame: 1 month

    Household Food Insecurity Access Scale

  16. Physical Activity

    Time frame: 1 month

    Stanford Patient Education Research Center Exercise Behaviors

  17. Number of Logins into the ECA

    Time frame: 1 month

    Intervention users only

  18. Duration of ECA Use

    Time frame: 1 month

    Intervention users only (minutes)

  19. Technical issues

    Time frame: 1 month

    Intervention users only

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 17, 2016
Registry last updated
Mar 16, 2017

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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