- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04171999
CommunityRx-Hunger (CRx-H)
CommunityRx-Hunger: A Hospital-based Intervention for Primary Caregivers of Children Admitted to the Hospital
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
CommunityRx-Hunger (CRx-H) is a double-blinded randomized controlled trial aimed at increasing self-efficacy among caregivers with food insecurity in the household. CRx-H is recruiting primary caregivers of hospitalized children at a large urban children's hospital at the time of admission. Aim 1: Researchers are studying whether the intervention will increase self-efficacy among food insecure caregivers compared to those who receive the usual standard of care. Aim 2: Researchers will enroll and randomize caregivers with and without food insecurity to the intervention to compare satisfaction with care.
Eligible, self-identified caregivers will complete a baseline survey during the child's hospital stay, followed by phone surveys at 7, 30, 90, 180 days, and 12 months. Caregivers randomized to the intervention will receive a tailored list of resources to address food insecurity and other health-related social needs, plus a brief educational component delivered by a trained member of our research team. Cases will receive a "booster" dose of the resource list prior to discharge. After discharge, cases will receive proactive text messages about those same community resources.
All caregivers (regardless of research arm) will receive a series of text messages related to the study such as reminders to schedule the phone survey with a member of the research team.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Native English or Spanish speaker
- Living in 1 of 27 zip codes in the study's target region
- Self-identify as a primary caregiver of a child <18 years old hospitalized in a large urban children's hospital
- Ability to send and receive text messages
- Access to a mobile phone and agrees to receive text messages from the study
Exclusion Criteria:
- Previous participation in a CRx research study.
- Caregivers of newborns in the hospital
- Patient hospital stay is less than 24 hours
- Patient hospital stay is 30 days or more
- Patient has an eating disorder as indicated in the EMR
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Usual Care + Intervention (Case)
Cases will receive the CommunityRx Intervention.
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The CRx-H Intervention provides "dosages" of health content that offer assistance for food insecurity and other health-related social needs.
A caregiver randomized to the intervention will receive a hard-copy print-out of their tailored list of resources to address food insecurity.
A member of our research team will deliver this list and provide a brief educational component which includes: a brief, structured script about the common problem of food insecurity in households with children and co-occuring HRSNs, review of the resource list which includes nearby, vetted resources to address these needs and coaching on how to activate resources on the list.
Prior to discharge, the caregiver will receive a duplicate copy of the list of resources.
After discharge, the caregiver will receive text messages at a frequency based on the Critical Time Intervention (CTI) Model, from baseline to 3 months post discharge, in order to receive ongoing support by a research team member.
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No Intervention: Usual Care (Control)
Controls will receive the usual standard care, which consists of information about hospital food resources and access to Feed1st hospital food pantries prior to discharge.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
(Aim 1) Change in caregiver self-efficacy at 12 months from baseline
Time Frame: Baseline, 12 months
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Self-efficacy is measured by Bandura's Self-Efficacy Scale which asks, "How confident are you in your ability to find resources in your community that help you manage your health?"
Responses will be assessed on a 5-point Likert scale ranging from "not at all confident" to "completely confident."
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Baseline, 12 months
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(Aim 2) Caregiver satisfaction with hospital care
Time Frame: 7 days post discharge from the hospital
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Satisfaction with hospital care is measured by the Hospital Consumer Assessment of Healthcare Providers Survey (HCAHPS); "Child HCAHPS" which includes 8 items plus one item added by the research team for a total of 9 items.
Response options are "Yes, definitely," "Yes, somewhat" and "No."
The items ask about the child and the hospital related to their recent stay.
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7 days post discharge from the hospital
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stacy T Lindau, MD, MPP, University of Chicago
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB20-0324
- 1R01MD012630-01A1 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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