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NCT04953169
Examining Health Literacy in Biorepository Consents
NA trial testing Biobank Video in Pediatric. Withdrawn.
30 June 2021
Quick facts
| Lead sponsor | Ann & Robert H Lurie Children's Hospital of Chicago |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | health services research |
| Start date | 13 July 2020 |
| Primary completion | 30 June 2021 |
| Estimated completion | 30 June 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Biobank Video
- Non-Video
Conditions studied
- Pediatric — all drugs for Pediatric →
- Critical Illness — all drugs for Critical Illness →
- Consent — all drugs for Consent →
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Who can join
18 and older, any sex, with Pediatric or Critical Illness. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Previous research has shown that most parents would allow their child's leftover blood to be included in a de-identified biorepository using opt-out consent in an outpatient setting. In a pilot study to evaluate Pediatric Intensive Care Unit (PICU) parents' preferences and comprehension of a written opt-in consent to include their child's sample in a biorepository, the investigators showed 19% of parents did not agree to participate in the Biobank, more than the 8.7% reported in other settings. Parent comprehension varied. and the investigators also noted differential enrollment by sociodemographic factors. Critically ill children and their parents are vulnerable; seeking consent for non-therapeutic research in critical care requires special consideration. Therefore, the goal of this study is to evaluate whether the addition of a stakeholder influenced (parent, clinical research professionals) video aided consent will improve comprehension and rates of enrollment across diverse groups in this high intensity setting.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04953169
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04953169 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ann & Robert H Lurie Children's Hospital of Chicago
- Last refreshed: 19 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04953169.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing