Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-03-02 @ 10:53 PM
Study NCT ID:
NCT04403633
Status:
RECRUITING
Last Update Posted:
2025-08-05
First Post:
2020-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Facilitators and Barriers to Improve Acute Kidney Injury in Children Through Mobile Health Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2020-05-21', 'studyFirstSubmitQcDate': '2020-05-21', 'lastUpdatePostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute Kidney Injury (AKI) Knowledge Assessment score', 'timeFrame': 'Baseline, 1 month', 'description': 'AKI Knowledge Assessment administered as pre-test prior to intervention and post-test one month after intervention. This assessment is scored with minimum value of 0% and maximum value of 100%. A higher score is a better outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AKI', 'Pediatric AKI', 'Acute Kidney Injury'], 'conditions': ['Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to improve patient-centered care for acute kidney injury (AKI) in order to decrease the adverse health outcomes associated with this common condition.', 'detailedDescription': "There is a need to provide better patient-centered care for acute kidney injury (AKI) in order to improve the adverse health outcomes associated with this common condition. This project involves thorough evaluation of patient and provider feedback on barriers and facilitators to pediatric AKI self-management in order to develop patient-centered pediatric AKI interventions. This will be done through interviews with families of patients diagnosed with AKI and providers who take care of these patients followed by integration of the results into modification of an existing educational tool previously used in adult patients. The study will take place in three parts with the first involving interviews, the second involving tool modification and usability testing, and the third involving pilot testing of the tool's impact."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 1 to 18 years\n* patients with diagnosis of AKI while hospitalized\n\nExclusion Criteria:\n\n* legal blindness of deafness\n* cognitive impairment that limits ability to consent\n* non-English speaking\n* patient age greater than age 18 years, 11 months'}, 'identificationModule': {'nctId': 'NCT04403633', 'briefTitle': 'A Study of Facilitators and Barriers to Improve Acute Kidney Injury in Children Through Mobile Health Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Improving Patient-Centered Care in Pediatric Acute Kidney Injury (Change Peds AKI)', 'orgStudyIdInfo': {'id': 'Pro00104197'}, 'secondaryIdInfos': [{'id': '1R38HL143612-01', 'link': 'https://reporter.nih.gov/quickSearch/1R38HL143612-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Receiving Educational Tool', 'description': 'Patients in this arm will receive the educational tool after the pretest in addition to usual care.', 'interventionNames': ['Other: mobile health educational tool']}, {'type': 'NO_INTERVENTION', 'label': 'Receiving Usual Care', 'description': 'Patients in this arm will receive usual care after the pretest.'}], 'interventions': [{'name': 'mobile health educational tool', 'type': 'OTHER', 'description': 'Interactive educational tool delivered on iPad', 'armGroupLabels': ['Receiving Educational Tool']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anna Williams', 'role': 'CONTACT', 'email': 'anna.e.williams@duke.edu', 'phone': '919-684-4246'}], 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'centralContacts': [{'name': 'Anna Williams', 'role': 'CONTACT', 'email': 'anna.e.williams@duke.edu', 'phone': '919-684-4246'}], 'overallOfficials': [{'name': 'Clarissa J Diamantidis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}, {'name': 'Rasheed Gbadegesin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}