Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-02-22 @ 4:52 PM
Study NCT ID:
NCT02876666
Status:
COMPLETED
Last Update Posted:
2017-07-28
First Post:
2016-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spinal Cord Injury Virtual Coach RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-26', 'studyFirstSubmitDate': '2016-08-19', 'studyFirstSubmitQcDate': '2016-08-23', 'lastUpdatePostDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Standardized Usability Questionnaire', 'timeFrame': 'Report at 2 month exit survey', 'description': "Evaluates the participant's self-reported experiences with the Coach on a number of characteristics, including ease of use, repetitiveness, and overall satisfaction."}], 'secondaryOutcomes': [{'measure': 'Health Education Impact Questionnaire - Skill Technique Acquisition', 'timeFrame': 'Baseline and 2 months', 'description': "Self-report measure of the participant's feelings about their ability to do skin behavior tasks"}, {'measure': 'Skin Care Behavior Compliance', 'timeFrame': 'Baseline and two months', 'description': 'Self-report measure of compliance with behaviors to prevent skin care problems that lead to pressure ulcers'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spinal Cord Injuries', 'Health Behavior'], 'conditions': ['Spinal Cord Injuries']}, 'descriptionModule': {'briefSummary': 'The SCI Virtual Coach study has developed an on-screen, human-like character that will provide support, education and coaching to adults with spinal cord injury (SCI) to aid in the prevention of serious secondary conditions like pressure ulcers. In a randomized controlled trial, participants assigned to "the Coach" intervention will have a touch-screen computer placed in their homes and be asked to interact with the Coach on a daily basis for 2 months. Participants will be asked to complete surveys at baseline and 2 months.\n\nThe SCI Virtual Coach study aims to measure how accessible and usable participants feel the Coach is, as well as participants\' adherence to the Coach\'s instructions. It will also gauge how effective the Coach is in changing self-care knowledge, health care behaviors, self-efficacy for self-care, and perception of social support in participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self-report of physician-confirmed chronic spinal cord injury diagnosis\n* Injured within the last 6 months -10 years\n* Speaks and understands conversational English\n* Lives within approximately 1 hour of Boston, MA\n\nExclusion Criteria:\n\n* Moderate to severe cognitive impairment\n* Expected to live less than 1 year'}, 'identificationModule': {'nctId': 'NCT02876666', 'briefTitle': 'Spinal Cord Injury Virtual Coach RCT', 'organization': {'class': 'OTHER', 'fullName': 'Boston University'}, 'officialTitle': 'Spinal Cord Injury Virtual Coach to Promote Self-Care in Pressure Ulcer Prevention', 'orgStudyIdInfo': {'id': 'H-33729'}, 'secondaryIdInfos': [{'id': '324644', 'type': 'OTHER_GRANT', 'domain': 'Craig H. Neilsen Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Coach Intervention', 'interventionNames': ['Behavioral: SCI Virtual Coach']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care'}], 'interventions': [{'name': 'SCI Virtual Coach', 'type': 'BEHAVIORAL', 'description': 'Participants are given a computer with the SCI Virtual Coach program and are asked to interact with the Coach daily for 2 months.', 'armGroupLabels': ['Coach Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'New England Regional SCI Center, Boston University School of Public Health', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Nancy Latham, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Craig H. Neilsen Foundation', 'class': 'OTHER'}, {'name': 'Northeastern University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}