Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2026-04-23 @ 7:08 PM
Study NCT ID:
NCT02534805
Status:
COMPLETED
Last Update Posted:
2025-09-09
First Post:
2015-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Patient Buddy App for the Prevention of Avoidable Readmission in Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jasmohan.bajaj@vcuhealth.org', 'phone': '(804) 828-4060', 'title': 'Dr. Jasmohan Bajaj', 'organization': 'Virginia Commonwealth University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '30 days', 'eventGroups': [{'id': 'EG000', 'title': 'Patient Buddy Subject Only/Not Dyad', 'description': 'Only the patients (subjects) were enrolled in this part of the study, not dyads. The numbers only represent the patient enrollment numbers. Patients were given phones loaded with the Buddy App, which was used to enter medications, issues, and orientation questions. They were seen on days 15 and 30 and received phone calls on days 7 and 21 inquiring about issues that would need medical attention.', 'otherNumAtRisk': 116, 'deathsNumAtRisk': 116, 'otherNumAffected': 0, 'seriousNumAtRisk': 116, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard of Care Subject Only/Not Dyad', 'description': 'Subjects randomized to standard of care and not the Buddy App. Just the patients counted and reported, not the dyads.', 'otherNumAtRisk': 116, 'deathsNumAtRisk': 116, 'otherNumAffected': 0, 'seriousNumAtRisk': 116, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Avoidable Readmission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patient Buddy Subject Only/Not Dyad', 'description': 'Only the patients (subjects) were enrolled in this part of the study, not dyads. The numbers only represent the subject enrollment numbers. Subjects were given phones loaded with the Buddy App, which was used to enter medications, issues, and orientation questions. They were seen on days 15 and 30 and received phone calls on days 7 and 21 inquiring about issues that would need medical attention.'}, {'id': 'OG001', 'title': 'Standard of Care Subject Only/Not Dyad', 'description': 'Subjects randomized to standard of care and not the Buddy App. Just the patients counted and reported, not the dyads.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Avoidable Readmissions within 30 days.', 'unitOfMeasure': 'Number of Avoidable Readmissions', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patient Buddy Subject Only/Not Dyad', 'description': 'No dyads enrolled in this part of the study. Only the patients (subjects) were enrolled in this part of the study, not dyads. The numbers only represent the patient enrollment numbers. Patients were given iphones loaded with the Buddy App that was used to enter medications, issues and orientation questions. They were seen at day 15 and day 30 and received a phone call day 7 and day 21 inquiring about issues that would need medical attention.'}, {'id': 'FG001', 'title': 'Standard of Care Subject Only/Not Dyad', 'description': 'No dyads enrolled in this part of the study. Subjects randomized to standard of care and not the Buddy App. Dyad unit not reported, only the patient/subject.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '116'}, {'groupId': 'FG001', 'numSubjects': '116'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '116'}, {'groupId': 'FG001', 'numSubjects': '116'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '232', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Patient Buddy Subject Only/Not Dyad', 'description': 'Subjects will be given iphones loaded with the App that will be used to enter medications, issues and orientation questions. They will be seen at day 15 and day 30 and will receive a phone call day 7 and day 21 inquiring about issues that would need medical attention'}, {'id': 'BG001', 'title': 'Standard of Care Subject Only/Not Dyad', 'description': 'Subjects randomized to standard of care and not the Buddy App'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.1', 'spread': '12.38', 'groupId': 'BG000'}, {'value': '58.42', 'spread': '8.89', 'groupId': 'BG001'}, {'value': '58.8', 'spread': '10.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '232', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Only the patients (subjects) were enrolled in this part of the study, not dyads. The numbers only represent the patient subject enrollment numbers. Subjects were given phones loaded with the Buddy App, which was used to enter medications, issues, and orientation questions. They were seen on days 15 and 30 and received phone calls on days 7 and 21 inquiring about issues that would need medical attention.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-08-01', 'size': 714012, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-20T18:31', 'hasProtocol': True}, {'date': '2020-06-09', 'size': 223117, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-05-20T18:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 232}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2015-08-05', 'resultsFirstSubmitDate': '2025-05-20', 'studyFirstSubmitQcDate': '2015-08-25', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-06-27', 'studyFirstPostDateStruct': {'date': '2015-08-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Avoidable Readmission', 'timeFrame': '30 days', 'description': 'Avoidable Readmissions within 30 days.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cirrhosis']}, 'descriptionModule': {'briefSummary': 'To use the PatientBuddy App to reduce 30-day avoidable readmissions in cirrhotic patients using a patient and caregiver perspective.', 'detailedDescription': 'Specific aim 1: To perform a pilot and feasibility study of disseminating current knowledge of readmission prevention in cirrhosis by using the Patient Buddy App with patient and caregiver interfaces. Eighty subjects (40 cirrhotic inpatients and 40 caregivers) will be enrolled and trained on the Patient Buddy at discharge. The App focuses on daily communication between patient/caregivers and the study team based on previously identified risk factors associated with readmission. The study team will initiate measures to prevent readmission using these communications. A detailed analysis of 30-day readmissions and input of the patients,caregivers and nurse manager will be performed to improve the App. Avoidable readmissions will be defined by a committee of hepatologists who is not part of the study at VCU.\n\nSpecific aim 2: To incorporate the opinion of key stakeholders (patients, caregivers and case managers) towards improving the Patient Buddy App in the prevention of avoidable readmission in cirrhosis. The input of the key stakeholders and the analysis of readmissions prevented during the pilot study will be used to update the App for preventing avoidable readmissions in future studies'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cirrhotic subjects who are hospitalized for non-elective reasons', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cirrhosis patients ≥21 years of age hospitalized for non-elective reasons\n* Adult caregiver and the patient living in the same house\n* Both (caregiver and patient) should be able to complete the Patient Buddy training and evaluation\n* Discharged home from the hospital\n* Patients who have VCU as a primary hospital base\n\nExclusion Criteria:\n\n* Elective hospitalization\n* Lack of an adult caregiver\n* Active alcohol/substance abuse within 1 month of the hospitalization\n* Unable to perform training or give consent\n* Patients discharged to hospice, nursing home or extended care facilities\n* Patients on Hemodialysis'}, 'identificationModule': {'nctId': 'NCT02534805', 'briefTitle': 'Patient Buddy App for the Prevention of Avoidable Readmission in Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Patient Buddy App for the Prevention of Avoidable Readmission in Cirrhosis', 'orgStudyIdInfo': {'id': 'HM20003950'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient Buddy', 'description': 'Subjects and caregivers will be given iphones loaded with the App that will be used to enter medications, issues and orientation questions. They will be seen at day 15 and day 30 and will receive a phone call day 7 and day 21 inquiring about issues that would need medical attention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Jasmohan S Bajaj, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VCU Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}