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App-Based vs Paper-Based Consent in Clinical Research (ConsentApp Trial)
N/A
Recruiting
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
ConsentApp Trial 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.Check my eligibility
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.See study design
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.
ConsentApp Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately after consent is given for the study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after consent is given for the study
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effectiveness of app-based consent versus paper-based consent
Secondary outcome measures
Trust in the research consent process when using app-based consent versus paper-based consent
ConsentApp 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
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Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,418 Previous Clinical Trials
2,466,968 Total Patients Enrolled
1 Trials studying Consent
72 Patients Enrolled for Consent
BC Children's Hospital Research InstituteOTHER
12 Previous Clinical Trials
2,192 Total Patients Enrolled
Matthias Görges, PhDPrincipal InvestigatorThe University of British Columbia
2 Previous Clinical Trials
80 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My child is taking medication to reduce anxiety.I choose not to use numbing cream on my child's hands.My child does not use words to communicate.My child has a permanent IV line or port.My child is scheduled for anesthesia through a mask before getting an IV.My child is between 2 to 5 years old and needs an IV for imaging tests.
Research Study Groups:
This trial has the following groups:- Group 1: Traditional paper-based consent
- Group 2: App-based consent
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment being extended to individuals of advanced age for this trial?
"According to the trial's selection standards, children aged 2-5 are eligible for participation."
Answered by AI
Is it possible to join the study group for this research endeavor?
"To meet the eligibility criteria for this medical study, potential participants must be between 2 and 5 years old and have appropriate guardian consent. A total of 150 enrollees are needed to complete the trial."
Answered by AI
How many participants have been recruited into this experiment up to now?
"Affirmative. Clinicaltrials.gov states that this study, which began recruiting on July 27th 2023, is still open for recruitment and requires 150 patients from a single site."
Answered by AI
Are any new participants currently being sought out for this experiment?
"Affirmative. According to information stored on clinicaltrials.gov, this medical study has been recruiting since July 27th 2023 and the last update was made on August 30th 2023. The research is hoping to find candidates across one location for a total of 150 participants."
Answered by AI
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