Stress, Emotional Clinical Trial
Official title:
A Randomized Controlled Trial of A Virtual Patient Advocate System: "Go to Gabby" for Health and Wellness Information
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04064151 -
A Research Study for Latina Women Undergoing Breast Cancer Treatment
|
N/A | |
Recruiting |
NCT04160611 -
What Amount of Stress is Enough for a Successful Conception?
|
Phase 3 | |
Completed |
NCT02947477 -
Emotion Tracking Study for Residents
|
N/A | |
Recruiting |
NCT05083871 -
Cognitive Appraisals and Team Performance Under Stress in Simulated Trauma Care
|
||
Active, not recruiting |
NCT05092542 -
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
|
N/A | |
Completed |
NCT03464955 -
VR Usage in Non-Invasive Surgical Sub-Specialty Procedures
|
N/A | |
Completed |
NCT06152549 -
Online Emotional Response to Completing a Childhood Maltreatment Self-report Scale
|
||
Completed |
NCT04977726 -
Resilience Curriculum for Novice Physicians-in-training
|
N/A | |
Active, not recruiting |
NCT04545021 -
My Health Day by Day (Mi Salud Dia a Dia)
|
||
Not yet recruiting |
NCT04173559 -
Sleep and Tracking Effects in Pregnancy Study
|
N/A | |
Not yet recruiting |
NCT05799534 -
Post-Coronavirus Disease of 2019 (COVID-19) Rehabilitation Clinics in Saudi Arabia
|
N/A | |
Completed |
NCT04927845 -
StriveWeekly Trial Post-pandemic
|
N/A | |
Active, not recruiting |
NCT04950816 -
Examining the Feasibility and Acceptability of a Tailored Version of a Mindfulness-Based Intervention (MBI) Among Youth Experiencing Homelessness (YEH)
|
Phase 1 | |
Completed |
NCT03645005 -
A Research Study for Latina Women After Breast Cancer Treatment
|
N/A | |
Completed |
NCT04595084 -
Remotely Delivered Programs Targeting COVID-19 Stress-Related Depression and Substance Use
|
N/A | |
Enrolling by invitation |
NCT06085105 -
Caring for Providers to Improve Patient Experience (CPIPE) Trial
|
N/A | |
Completed |
NCT05933746 -
Sleep Hygiene Intervention on Undergraduate Students' Sleep and Stress
|
N/A | |
Enrolling by invitation |
NCT06063174 -
Stress & Resilience Study
|
N/A | |
Completed |
NCT05304000 -
Psychophysiological Effects of Controlled Respiration and Mindfulness
|
N/A | |
Completed |
NCT04441632 -
Effect of Positive Attitudes on Behavior and Wellness
|
N/A |