Stress, EmotionalNCT02965651
Engaging Women With the Gabby System to Deliver Multiple Health-Related Behavioral Changes: A Feasibility Study
A study testing ECA System in people with Stress, Emotional, run by Boston Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress, Emotional
- What is being tested?
- ECA System
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Known or planned pregnancy
- Mental health or substance abuse problems that would bar completion of study
- Refusal of consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stress, Emotional
- Being tested
- ECA System
- Keywords
- embodied conversational agent, virtual patient agent, meditation, mindfulness based stress reduction, nutrition
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECA SystemBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ECA System | Experimental | Access to website and virtual patient advocate Receives: Behavioral: ECA System |
| Standard of Care | No intervention | Patient information sheets and meditation CD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of people recruited
Measured: 1 year
Number of participants who completed the study
Measured: 1 month
Number of participants whom outcome data can be collected
Measured: 1 month
Number of participants who were racial minorities (non-white)
Measured: 1 month
Participant satisfaction with either treatment arm
Likert scale of 1-7 (1=not satisfied, 7=very satisfied)
Measured: 1 month
Secondary outcomes (19)
Age
Measured: 1 month
Race
Measured: 1 month
Ethnicity
Measured: 1 month
Education Level
Measured: 1 month
Work Status
Measured: 1 month
Income Level
Measured: 1 month
BMI
Height (ft) and weight (lbs)
Measured: 1 month
Health Conditions
Self-reported; cross-checked with medical records
Measured: 1 month
Medication Use
Self-reported; cross-checked with medical records
Measured: 1 month
Smoking Status
Measured: 1 month
Pain Levels
Pain scale of 0-10 (0=no pain, 10=worst possible pain)
Measured: 1 month
Depression
Patient Health Questionnaire - 9 items
Measured: 1 month
Stress Level
Perceived Stress Scale - 4 items
Measured: 1 month
Dietary Patterns
Nutrition Survey
Measured: 1 month
Food Access
Household Food Insecurity Access Scale
Measured: 1 month
Physical Activity
Stanford Patient Education Research Center Exercise Behaviors
Measured: 1 month
Number of Logins into the ECA
Intervention users only
Measured: 1 month
Duration of ECA Use
Intervention users only (minutes)
Measured: 1 month
Technical issues
Intervention users only
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startJan 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress, EmotionalStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paula Gardiner, Boston Medical Center
- Investigators
- Paula Gardiner, MD, MPH, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965651
- Sponsor's protocol ID
- H-30418
- Status last verified
- Mar 2017
- First submitted
- 7 Nov 2016
- Last updated
- 16 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 23286652
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of A Virtual Patient Advocate System: "Go to Gabby" for Health and Wellness Information
- ClinicalTrials.gov ID
- NCT02965651
- Acronym / sponsor ID
- H-30418
- Conditions
- Stress, Emotional
- Keywords
- embodied conversational agent, virtual patient agent, meditation, mindfulness based stress reduction, nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 17 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECA System | Experimental | Behavioral: ECA SystemAccess to website and virtual patient advocate |
| Standard of Care | No intervention | –Patient information sheets and meditation CD |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Known or planned pregnancy
- Mental health or substance abuse problems that would bar completion of study
- Refusal of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECA SystemThe 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. | Behavioural | ECA System |
Primary outcome
Number of people recruited
Time frame: 1 year
Number of participants who completed the study
Time frame: 1 month
Number of participants whom outcome data can be collected
Time frame: 1 month
Number of participants who were racial minorities (non-white)
Time frame: 1 month
Participant satisfaction with either treatment arm
Time frame: 1 month
Likert scale of 1-7 (1=not satisfied, 7=very satisfied)
19 secondary outcomes
Age
Time frame: 1 month
Race
Time frame: 1 month
Ethnicity
Time frame: 1 month
Education Level
Time frame: 1 month
Work Status
Time frame: 1 month
Income Level
Time frame: 1 month
BMI
Time frame: 1 month
Health Conditions
Time frame: 1 month
Medication Use
Time frame: 1 month
Smoking Status
Time frame: 1 month
Pain Levels
Time frame: 1 month
Depression
Time frame: 1 month
Stress Level
Time frame: 1 month
Dietary Patterns
Time frame: 1 month
Food Access
Time frame: 1 month
Physical Activity
Time frame: 1 month
Number of Logins into the ECA
Time frame: 1 month
Duration of ECA Use
Time frame: 1 month
Technical issues
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
- Results publication: PubMed 23286652Gardiner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula Gardiner, MD, MPH principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECA System in people with Stress, Emotional, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of people recruited (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02965651, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2017.