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App-Based vs Paper-Based Consent in Clinical Research (ConsentApp Trial)

N/A
Waitlist Available
Led By Matthias Görges, PhD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately after consent is given for the study
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to compare app-based consent with paper-based consent to see which works better for recruiting families for clinical research. Results will measure comprehension and preference.

Who is the study for?
This trial is for children aged 2 to 5 who require an IV insertion in the medical imaging department. It excludes nonverbal children, those with existing vascular access, families opting out of topical anesthetic for their child's hands, and children receiving certain anesthesia methods or anxiety medication before IV placement.
What is being tested?
The study compares app-based consent with traditional paper-based consent for clinical research recruitment. Effectiveness will be measured by how well families understand and prefer the process through questionnaires.
What are the potential side effects?
Since this trial involves methods of obtaining consent rather than medical treatments, there are no direct physical side effects associated with the interventions being tested.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after consent is given for the study
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after consent is given for the study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Effectiveness of app-based consent versus paper-based consent
Secondary study objectives
Trust in the research consent process when using app-based consent versus paper-based consent

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: App-based consentExperimental Treatment1 Intervention
Prototype consent app based on REDCap eConsent module
Group II: Traditional paper-based consentActive Control1 Intervention
Traditional paper-based consent
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Consent App
2023
N/A
~120

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,481 Previous Clinical Trials
2,494,796 Total Patients Enrolled
1 Trials studying Consent
72 Patients Enrolled for Consent
BC Children's Hospital Research InstituteOTHER
12 Previous Clinical Trials
2,187 Total Patients Enrolled
Matthias Görges, PhDPrincipal InvestigatorThe University of British Columbia
2 Previous Clinical Trials
80 Total Patients Enrolled

Media Library

App-based consent Clinical Trial Eligibility Overview. Trial Name: NCT05880147 — N/A
Consent Research Study Groups: Traditional paper-based consent, App-based consent
Consent Clinical Trial 2023: App-based consent Highlights & Side Effects. Trial Name: NCT05880147 — N/A
App-based consent 2023 Treatment Timeline for Medical Study. Trial Name: NCT05880147 — N/A
~50 spots leftby Dec 2025
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