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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02965651
Other study ID # H-30418
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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