Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2026-01-22 @ 7:19 AM
Study NCT ID:
NCT01859104
Status:
WITHDRAWN
Last Update Posted:
2018-03-22
First Post:
2013-05-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Use of BariCare App in Pre-transplant Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'App to be used in study needs revision.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-20', 'studyFirstSubmitDate': '2013-05-17', 'studyFirstSubmitQcDate': '2013-05-17', 'lastUpdatePostDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Smart Phone App Feasibility', 'timeFrame': '3 months', 'description': 'The primary objective will be to assess ease and feasibility of use by subjects. They will provide information through questionnaires developed to assess these factors.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity', 'Pre-Renal Transplant Candidate', 'Pre-liver Transplant Candidate']}, 'descriptionModule': {'briefSummary': 'This current study aims to evaluate the efficacy of engagement modules in assisting patients who are candidates for renal and liver transplantation make significant lifestyle modifications. With the help of the Center for Innovation (CFI), a smartphone app (Android and iOS compatible) has been created to assist in both educating and engaging patients to develop and maintain healthy lifestyle modifications. Our goal is to create a cost-effective, smartphone-based platform that serves to not only efficiently educate but to also verify competence and keep our patients engaged.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Individuals who are candidates for liver or renal transplant.\n2. Individuals who own a smartphone.\n3. Individuals who are obese.\n\nExclusion Criteria:\n\n1. Patients with prior history of bariatric surgery.\n2. Patients with active psychiatric disorder.\n3. Patients with active tobacco use.\n4. Patients with active substance use (alcohol, illicit drugs, etc.)'}, 'identificationModule': {'nctId': 'NCT01859104', 'briefTitle': 'Feasibility of Use of BariCare App in Pre-transplant Population', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Feasibility and Efficacy of Engagement Modules for Renal and Liver Transplant Candidates', 'orgStudyIdInfo': {'id': '13-001535'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Smartphone Arm', 'description': 'This is a feasibility trial and thus all participants in the study will be provided a smartphone app to assist them in making lifestyle modifications', 'interventionNames': ['Behavioral: Use of smartphone app']}], 'interventions': [{'name': 'Use of smartphone app', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Smartphone Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Manpreet Mundi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Manpreet S. Mundi', 'investigatorAffiliation': 'Mayo Clinic'}}}}