Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-02-24 @ 12:13 AM
Study NCT ID:
NCT05454969
Status:
RECRUITING
Last Update Posted:
2024-10-01
First Post:
2022-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
One-4-ALL Initiative
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067010', 'term': 'Literacy'}, {'id': 'D000084802', 'term': 'Caregiver Burden'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}], 'ancestors': [{'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a randomized controlled trial to examine pre-post differences between individuals that use the app versus the standard of care.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-27', 'studyFirstSubmitDate': '2022-06-27', 'studyFirstSubmitQcDate': '2022-07-07', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health care quality', 'timeFrame': 'post-intervention (12 weeks)', 'description': 'Health care quality will be assessed using six domains; safety, effective, patient-centered, timely, efficient, and equitable. Likert scale 1-5, higher score is best.'}, {'measure': 'Provider satisfaction', 'timeFrame': 'post-intervention (12 weeks)', 'description': 'Provider job satisfaction including level of burden and overall job satisfaction. Likert scale 1-5, higher score is best.\n\nphysical and mental health'}, {'measure': 'Patient satisfaction', 'timeFrame': 'post-intervention (12 weeks)', 'description': "Patient's satisfaction of the program tool. Likert scale 1-5, higher score is best.\n\nliteracy of the patient \\& their family, patient \\& family anxiety pre-surgery."}, {'measure': 'Acceptability of program tool', 'timeFrame': 'post-intervention (12 weeks)', 'description': "Patient's ability to engage and understand the program tool. Likert scale 1-5, higher score is better."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Literacy', 'Burden, Caregiver', 'Health Care Utilization']}, 'descriptionModule': {'briefSummary': 'This study aims to improve health outcomes of individuals and populations, enhance the patient experience, reduce the per capita cost of care, and ensure the well-being of our healthcare providers (quadruple aim). These goals are increasingly difficult to achieve, given the challenges of changes to workflow, staffing shortages, and increased costs brought on by the COVID-19 pandemic. Further, the pandemic brought to light the critical need to transform healthcare access for our racially and culturally minoritized and low-income families that have long been victims of health disparities, specifically with poorer health outcomes.', 'detailedDescription': 'The overall objective is to successfully implement a patient app that will be used by families to 1) increase throughput for all patients, including minoritized, low-income, and low health literacy patients, and 2) reduce administrative burdens on providers.\n\nTo evaluate this hypothesis, the following specific aims will be examined:\n\nAim 1: Document modifiable factors that negatively and positively impact providers\' ability to provide high-quality patient care in a post-pandemic healthcare system while addressing health disparities through implementation science.\n\nAim 2: Create a "boarding pass\' experience for providers and patients using technology (app) which allows patients and their families to fully prepare for their clinical visits and bridge care between home, primary care providers, and specialty care.\n\nAim 3: Investigate multilevel contextual factors related to app implementation, to inform future strategies to promote scalability and sustainability of app in all specialties.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All guardians of patients and the providers (surgeons, doctors, nurses, etc) that serve these patients.\n\nExclusion Criteria:\n\n* None.'}, 'identificationModule': {'nctId': 'NCT05454969', 'briefTitle': 'One-4-ALL Initiative', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Transforming Healthcare in Post-Pandemic Recovery: Innovation in Process & Technology to Increase Patient Throughput While Reducing Clinician Burden and Addressing Health Disparities (One-4-ALL Initiative)', 'orgStudyIdInfo': {'id': '22-0995'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'One-4-ALL Initiative', 'description': 'The health app arm will pilot the intervention and key outcome measures will be compared between the Health App group and the placebo control.', 'interventionNames': ['Behavioral: One-4-ALL Initiative']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Will receive standard care.', 'interventionNames': ['Behavioral: Control']}], 'interventions': [{'name': 'One-4-ALL Initiative', 'type': 'BEHAVIORAL', 'description': 'We can successfully implement a patient app that will be used by families to 1) increase throughput for all patients, including minoritized, low-income, and low health literacy patients, and 2) reduce administrative burdens on providers.', 'armGroupLabels': ['One-4-ALL Initiative']}, {'name': 'Control', 'type': 'BEHAVIORAL', 'description': 'Patients will receive standard of care.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jill Landsbaugh Kaar, PhD', 'role': 'CONTACT', 'email': 'jill.kaar@cuanschutz.edu', 'phone': '720-777-3571'}], 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'centralContacts': [{'name': 'Jill Landsbaugh Kaar, PhD', 'role': 'CONTACT', 'email': 'jill.kaar@cuanschutz.edu', 'phone': '17207773571'}], 'overallOfficials': [{'name': 'Jill Landsbaugh Kaar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}