Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-31 @ 2:30 AM
Study NCT ID:
NCT04976933
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2021-07-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-HSCT Medication Adherence mHealth App
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-07', 'studyFirstSubmitDate': '2021-07-15', 'studyFirstSubmitQcDate': '2021-07-15', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'System Usability Scale (SUS)', 'timeFrame': 'Baseline to day 100', 'description': 'The SUS is a 10-item questionnaire used to evaluate the functionality and acceptability of mHealth apps. Items are rated on a 5 point scale and final scores on the measure range from 0 to 100. Higher scores represent better functionality and acceptability. Scores of \\> 68 are considered above average.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adherence, mHealth'], 'conditions': ['Stem Cell Transplantation']}, 'referencesModule': {'references': [{'pmid': '35862184', 'type': 'DERIVED', 'citation': 'Skeens M, Sezgin E, Stevens J, Landier W, Pai A, Gerhardt C. An mHealth App to Promote Adherence to Immunosuppressant Medication and Track Symptoms in Children After Hematopoietic Stem Cell Transplant: Protocol for a Mixed Methods Usability Study. JMIR Res Protoc. 2022 Jul 21;11(7):e39098. doi: 10.2196/39098.'}]}, 'descriptionModule': {'briefSummary': 'Through a mixed methods, quasi-experimental design, the study will first focus on developing a mobile health (mHealth) adherence application and evaluating usability and acceptability of the app among caregivers of children in the acute phase post-HSCT. The purpose of this project is to explore the feasibility and acceptability of a mHealth application through user testing and thematic content analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary caregivers and health care providers of children discharged during the acute phase (first 100 days) post-hematopoietic stem cell transplant (HSCT).', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English-speaking\n* \\>18 years of age\n\nExclusion Criteria:\n\n* Caregivers with developmental delays or conditions that make processing and responding to verbal questions challenging/frustrating either online or in a group forum'}, 'identificationModule': {'nctId': 'NCT04976933', 'briefTitle': 'Post-HSCT Medication Adherence mHealth App', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'officialTitle': 'Design and Feasibility of mHealth App for Pediatric Medication Adherence Post-discharge for Hematopoietic Stem Cell Transplant', 'orgStudyIdInfo': {'id': 'STUDY00000910'}, 'secondaryIdInfos': [{'id': 'K99NR019115-01A1', 'link': 'https://reporter.nih.gov/quickSearch/K99NR019115-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primary Caregivers', 'description': 'Primary caregivers of children receiving Tacrolimus or cyclosporine immunosuppression for an allogeneic transplant will be introduced to the mHealth adherence app and allowed the opportunity to interact with the app alongside research staff. Following this session primary caregivers are asked to use the app at home until Day 100 or weaning of immunosuppressant, whichever is first.', 'interventionNames': ['Behavioral: mHealth adherence app']}], 'interventions': [{'name': 'mHealth adherence app', 'type': 'BEHAVIORAL', 'description': 'The mHealth app is designed to remind caregivers to give medication in the outpatient setting, track adherence, and capture real time barriers to adherence if medication is missed.', 'armGroupLabels': ['Primary Caregivers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Micah Skeens, PhD APRN CPNP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Abigail Wexner Research Institute at Nationwide Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Micah Skeens', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Nurse Scientist/Principal Investigator', 'investigatorFullName': 'Micah Skeens', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}