NCT07122960|Active Not Recruiting
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Sponsor study identifier
Secondary identifiers
NIH
interventional
58
1 country
1
Study Start
September 2, 2024
Actual (reported)Primary Completion
December 4, 2025
Actual (reported)Study Completion
July 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This study evaluates a visual Informed Consent Form (ICF) compared to a standard, text-only ICF as an approach to achieving meaningful consent into a clinical trial. The visual ICF uses cartoon characters, graphics and easy-to-understand text to cover the full content of a standard, text-only ICF. In this study, women who are considering enrollment into a clinical trial of a nutrition intervention for their infants will be randomized to either the visual ICF or to the text-only ICF. Qualitative and quantitative data will be collected immediately after the consent process and 8 weeks later. In addition, women not eligible for enrollment into the infant nutrition trial will be asked questions about their opinions regarding the visual ICF. The overall goal of the sub-study is to inform efforts to improve meaningful consent into clinical trials by evaluating whether the visual ICF improves understanding of the trial.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2, 2024
Actual (reported)August 8, 2025
Actual (reported)August 14, 2025
Actual (reported)December 4, 2025
Actual (reported)July 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Summed score from the validated Quality of Informed Consent (QUIC) instrument.
The QUIC measures knowledge recall. The summed score of 10 knowledge items comprising key concepts of informed consent will be calculated. The scores range between 0 and 22 with higher scores indicating higher knowledge.
Immediately after the consent process (Day 0) and 8 weeks later
Self-rated Understanding
Immediately after consent process (Day 0)
Decision Regret Scale
8 weeks after consent process
This visual ICF fully represents all the content of the standard, text-only ICF using cartoon characters, graphics and easy text.
Text-only ICF
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Stellenbosch University Wooster Rural Campus
Worcester, Western Cape, 6850, South Africa
Louise Kuhn, PhD
Columbia University
58 participants (actual enrollment reported by the registry).
First Submitted
August 8, 2025
First Posted
August 14, 2025
Study Start
September 2, 2024
Actual (reported)Education Intervention in Patients with Rash Due to Epidermal Growth Factor Receptor (EGFR) Treatment.
Contact the study team to confirm eligibility.
Primary Completion
December 4, 2025
Actual (reported)Study Completion
July 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 16, 2026
Record last verified: 2026-07
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Source: ClinicalTrials.gov.
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