Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-03-12 @ 2:34 AM
Study NCT ID:
NCT03173794
Status:
WITHDRAWN
Last Update Posted:
2020-04-24
First Post:
2017-05-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CommunityRx for Hunger: A Hospital-Based Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'This trial was a duplicate entry. Recruitment was never open and no participants were enrolled.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-22', 'studyFirstSubmitDate': '2017-05-30', 'studyFirstSubmitQcDate': '2017-06-01', 'lastUpdatePostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from baseline in caregiver stress', 'timeFrame': 'Baseline, 7 days, 30 days, 60 days, and 90 days', 'description': 'Caregiver stress will be measured using the Perceived Stress Scale (PSS). Measure is included in the NIH Common Data Element Repository'}, {'measure': 'Change from baseline in caregiver burden', 'timeFrame': 'Baseline, 7 days, 30 days, 60 days, and 90 days', 'description': 'Caregiver burden will be measured using the Caregiver Burden Scale (CGBS). Measure is included in the NIH Common Data Element Repository'}, {'measure': 'Change from baseline in caregiving self-efficacy', 'timeFrame': 'Baseline, 7 days, 30 days, 60 days, and 90 days', 'description': 'Caregiver self-efficacy will be measured using General Self-Efficacy Scale (GSE). Measure is included in the NIH Common Data Element Repository'}, {'measure': 'Change from baseline in contact Community Resource Navigator', 'timeFrame': 'Baseline, 7 days, 30 days, 60 days, and 90 days', 'description': 'Change in contact with Community Resource Navigator will be measured using investigator-generated questions'}, {'measure': 'Satisfaction with navigation', 'timeFrame': '7 days', 'description': 'Patient satisfaction with logistical aspects of navigation will be measured using investigator-generated questions'}, {'measure': "Change in stigma during child's hospital stay", 'timeFrame': '7 days, 30 days, 60 days, 90 days', 'description': 'Change in stigma will be measured using the Experiences of Discrimination Scale (EDS)'}], 'primaryOutcomes': [{'measure': 'Change from baseline in use of food resources', 'timeFrame': 'Baseline, 7 days, 30 days, 60 days, and 90 days', 'description': 'Change in use of food resources will be measured using investigator-generated questions about use of the resources for self or others, sharing of information about the resources'}, {'measure': 'Patient satisfaction with care', 'timeFrame': '7 days', 'description': 'Patient satisfaction will be measured using the Patient Satisfaction Questionnaire (PSQ-18)'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in mental health-related quality of life', 'timeFrame': 'Baseline, 7 days, 30 days, 60 days, and 90 days', 'description': 'Mental health-related quality of life will be measured using the Medical Outcomes Study Short Form-36'}, {'measure': 'Change from baseline in household food insecurity', 'timeFrame': 'Baseline, 30 days, 60 days, and 90 days', 'description': 'Household food insecurity will be measured using the 18-item Household Food Security Survey'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Food Insecurity', 'Caregivers', 'Clinical Trial', 'Hunger', 'Health-Related Quality of Life', 'Patient Satisfaction']}, 'descriptionModule': {'briefSummary': "The goal of this research program is to reduce health disparities by deploying an information-based intervention to increase caregiver utilization of community-based food supports and satisfaction with care among food insecure caregivers of hospitalized children. We will conduct a randomized controlled trial to evaluate, versus usual care, the effects of the CommunityRx-H intervention on caregiver use of food resources (primary), caregiver patient satisfaction with care (primary), caregiver mental health-related quality of life (secondary), and caregiver household food security (secondary). The proposed research will yield an understanding of how to leverage a child's hospitalization to effectively intervene on the problem of food insecurity. Findings will inform the rapidly growing field of healthcare-based interventions to address health-related social needs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* At least 18 years old\n* English-speaking\n* Living in 1 of the 16 ZIP code target regions\n* Self-identify as a primary caregiver of a child \\<18 years old hospitalized in CCH's general, intensive care or transplant units\n\nExclusion Criteria:\n\n* Recollection of previous receipt of a HealtheRx"}, 'identificationModule': {'nctId': 'NCT03173794', 'briefTitle': 'CommunityRx for Hunger: A Hospital-Based Intervention', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': "CommunityRx for Hunger: A Children's Hospital-Based Intervention to Support Caregivers in an African American Community", 'orgStudyIdInfo': {'id': 'IRB17-0770'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Care Only', 'description': 'The control group will receive usual care, no CommunityRx-H intervention'}, {'type': 'EXPERIMENTAL', 'label': 'Usual Care and Intervention', 'description': 'The intervention arm will receive the CommunityRx-H intervention, an information-based intervention that provides referrals to community resources', 'interventionNames': ['Other: CommunityRx-H']}], 'interventions': [{'name': 'CommunityRx-H', 'type': 'OTHER', 'description': 'CommunityRx-H has two components: (1) health-information technology (HIT) e-prescribing, and (2) a Community Resource Specialist (CRS). CommunityRx functions like an e-prescribing system: a HealtheRx "prescription" is automatically generated at the point of care. The HealtheRx provides referrals to food resources and federal nutrition assistance information tailored to the caregiver\'s address and proactive social support in the form of SMS-text message nudges from the CRS. Caregivers in the intervention arm are able to request information on resources not limited to food, including employment support, help paying rent or mortgage, etc. Nudges will promote caregiver self- and family management by increasing knowledge of and encouraging activation of community resources.', 'armGroupLabels': ['Usual Care and Intervention']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Stacy Lindau, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}