Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-02-12 @ 6:16 PM
Study NCT ID:
NCT02965651
Status:
COMPLETED
Last Update Posted:
2017-03-16
First Post:
2016-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Engaging Women With the Gabby System to Deliver Multiple Health-Related Behavioral Changes: A Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013315', 'term': 'Stress, Psychological'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-15', 'studyFirstSubmitDate': '2016-11-07', 'studyFirstSubmitQcDate': '2016-11-14', 'lastUpdatePostDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of people recruited', 'timeFrame': '1 year'}, {'measure': 'Number of participants who completed the study', 'timeFrame': '1 month'}, {'measure': 'Number of participants whom outcome data can be collected', 'timeFrame': '1 month'}, {'measure': 'Number of participants who were racial minorities (non-white)', 'timeFrame': '1 month'}, {'measure': 'Participant satisfaction with either treatment arm', 'timeFrame': '1 month', 'description': 'Likert scale of 1-7 (1=not satisfied, 7=very satisfied)'}], 'secondaryOutcomes': [{'measure': 'Age', 'timeFrame': '1 month'}, {'measure': 'Race', 'timeFrame': '1 month'}, {'measure': 'Ethnicity', 'timeFrame': '1 month'}, {'measure': 'Education Level', 'timeFrame': '1 month'}, {'measure': 'Work Status', 'timeFrame': '1 month'}, {'measure': 'Income Level', 'timeFrame': '1 month'}, {'measure': 'BMI', 'timeFrame': '1 month', 'description': 'Height (ft) and weight (lbs)'}, {'measure': 'Health Conditions', 'timeFrame': '1 month', 'description': 'Self-reported; cross-checked with medical records'}, {'measure': 'Medication Use', 'timeFrame': '1 month', 'description': 'Self-reported; cross-checked with medical records'}, {'measure': 'Smoking Status', 'timeFrame': '1 month'}, {'measure': 'Pain Levels', 'timeFrame': '1 month', 'description': 'Pain scale of 0-10 (0=no pain, 10=worst possible pain)'}, {'measure': 'Depression', 'timeFrame': '1 month', 'description': 'Patient Health Questionnaire - 9 items'}, {'measure': 'Stress Level', 'timeFrame': '1 month', 'description': 'Perceived Stress Scale - 4 items'}, {'measure': 'Dietary Patterns', 'timeFrame': '1 month', 'description': 'Nutrition Survey'}, {'measure': 'Food Access', 'timeFrame': '1 month', 'description': 'Household Food Insecurity Access Scale'}, {'measure': 'Physical Activity', 'timeFrame': '1 month', 'description': 'Stanford Patient Education Research Center Exercise Behaviors'}, {'measure': 'Number of Logins into the ECA', 'timeFrame': '1 month', 'description': 'Intervention users only'}, {'measure': 'Duration of ECA Use', 'timeFrame': '1 month', 'description': 'Intervention users only (minutes)'}, {'measure': 'Technical issues', 'timeFrame': '1 month', 'description': 'Intervention users only'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['embodied conversational agent', 'virtual patient agent', 'meditation', 'mindfulness based stress reduction', 'nutrition'], 'conditions': ['Stress, Emotional']}, 'referencesModule': {'references': [{'pmid': '23286652', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).\n\nThe 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.\n\nIf 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.\n\nPrior 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.\n\nPrior 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.\n\nThe RA will conduct the post intervention interview in person or by phone. All participants received compensation for completion of surveys.\n\nControl 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English fluency sufficient to follow treatment instructions and answer survey questions\n* Access to a telephone (landline, cellular phone)\n* Access to a computer/laptop with internet/Wi-Fi access\n\nExclusion Criteria:\n\n* Known or planned pregnancy\n* Mental health or substance abuse problems that would bar completion of study\n* Refusal of consent'}, 'identificationModule': {'nctId': 'NCT02965651', 'briefTitle': 'Engaging Women With the Gabby System to Deliver Multiple Health-Related Behavioral Changes: A Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'Boston Medical Center'}, 'officialTitle': 'A Randomized Controlled Trial of A Virtual Patient Advocate System: "Go to Gabby" for Health and Wellness Information', 'orgStudyIdInfo': {'id': 'H-30418'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ECA System', 'description': 'Access to website and virtual patient advocate', 'interventionNames': ['Behavioral: ECA System']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Patient information sheets and meditation CD'}], 'interventions': [{'name': 'ECA System', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['ECA System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Paula Gardiner, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Paula Gardiner', 'investigatorAffiliation': 'Boston Medical Center'}}}}