An interventional study of Consent App and Traditional paper-based consent in Consent, sponsored by University of British Columbia. Completed at 1 site in Canada. Open to participants aged 2 Years to 5 Years. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by University of British Columbia · Not applicable, Interventional, and Health services research
This study aims to understand how well app-based consent performs compared to paper-based consent when recruiting families for a clinical research project. The investigators aim to demonstrate that app-based consent is as effective as traditional methods; this will be measured by questionnaires assessing the family's comprehension and preference.
Purpose and justification:
Wider access to digital technologies, familiarity with apps, and the Coronavirus disease 2019 (COVID-19) pandemic increased the demand for virtual care, prompting the need for electronic documentation of consent for research as families no longer attend in-person clinics. The investigators previously developed an app to consent patients for donating research study data in addition to traditional paper-based consent. This study aims to understand how well app-based consent performs compared to paper-based consent when recruiting families for a clinical research project.
The investigators aim to demonstrate that app-based consent is as effective as traditional methods measured by questionnaires assessing the family's comprehension and preference. If successful, this study will provide evidence for using app-based consent to enable future researchers to use similar approaches or help us further improve our app. Supporting a diverse array of consenting methods that are equivalent in promoting comprehension and participant preferences can improve research recruitment rates and increase research participant satisfaction.
Hypotheses: App-augmented consent is not inferior to traditional paper-based consent in ensuring comprehension.
Research Design:
This project will be integrated into an anesthesia study (evaluating bubble blowing as a method of distraction during IV insertions in young children, known as the BubblesRCT) by adding app-based consent and its evaluation into the regular consent flow so that families experience either app-based or traditional paper-based consent. The questions used are drawn from an established consent comprehension questionnaire and were modified to suit the requirements of our anesthesia study. Participants will also be asked a series of questions to measure characteristics like participant trust and the ease of the consenting process.
This consent modality trial will have a separate allocation schedule. Any family, who may participate in BubblesRCT, and who can be approached for consent will be allocated either to this trial's intervention (Consent modality app) or control (Consent modality paper), whereby the allocation will be switched after four participants; this is for operational feasibility purposes as randomization before approaching the parent would delay recruitment. As blinding is impossible, there will be no attempt to conceal consent modality allocation from the clinical or study teams.
Data collection:
Statistical Analysis:
The block-randomized controlled trial for non-inferiority of consent modality will tabulate results and use Wilcoxon rank sum tests for the composite comprehension correctness score. Groups will also be compared element-wise for the Likert scales using Wilcoxon rank sum tests; results may also be interpreted qualitatively.
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This study's enrollment of 120 is above the median of 68 across 2,861 interventional studies indexed under Alzheimer Disease.
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Exclusion Criteria:
Prototype consent app based on REDCap eConsent module
Device: Consent App
Traditional paper-based consent
Other: Traditional paper-based consent
Family will receive their study information and consent form in an app on a tablet
Patient/family will receive their study information and consent on a traditional paper form
Effectiveness of app-based consent versus paper-based consent
To determine better or similar comprehension of study requirements, risks and benefits, as measured by a comprehension questionnaire, and better or similar family preference for this mode of consenting. Scored using a 5-item custom multiple-choice test, with higher scores being better.
Time frame: Immediately after consent is given for the study
Trust in the research consent process when using app-based consent versus paper-based consent
To determine whether app-based consent increases trust in the research consent process using a single Likert scale question (range 1-5, higher is better)
Time frame: Immediately after consent is given for the study
Plan to share: Yes — Results will be presented at scientific conferences and published in peer-reviewed anesthesia journals. Once data collection is complete, a de-identified version of the data may be made available to other researchers. This is stated explicitly in the consent form, and participants are notified during the consent process that their de-identified data may be released to others for research purposes.
Supporting information: Study protocol, Informed consent form
Time frame: Once data collection is complete, de-identified data will be deposited in the University of British Columbia (UBC)'s Dataverse Repository. The study teams will keep research data for five years post-publication, as outlined in the UBC study data retention guidelines, after which it will be destroyed.
Access criteria: Details have yet to be determined.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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