Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
120 participants
INTERVENTIONAL
2023-07-27
2024-07-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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:
1. The research assistant (RA) will thoroughly explain the BubblesRCT study, answer any preliminary questions, and leave the family with either a detailed paper consent form to review (Consent modality control group) or an iPad containing the consent app for review (Consent modality intervention group).
2. The family will get 15 minutes to review the consent information privately.
3. After the family have read the paper or the app-based consent form, an RA will answer any questions about the study that the family might have and invite them to consent to the BubblesRCT study. The parents will provide consent to the study either on paper or within the app (using the REDCap Electronic Informed Consent \[eConsent\] framework).
4. All participants who have been approached, whether the family agree to participate in the Bubbles RCT or not, will be asked to complete a comprehension questionnaire with multiple-choice questions based on a modified form of the Deaconess Informed Consent Comprehension Test (DICCT) and with a selected a set of comprehension questions with known correct answer(s) that can be used to determine accuracy.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
App-based consent
Prototype consent app based on REDCap eConsent module
Consent App
Family will receive their study information and consent form in an app on a tablet
Traditional paper-based consent
Traditional paper-based consent
Traditional paper-based consent
Patient/family will receive their study information and consent on a traditional paper form
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Consent App
Family will receive their study information and consent form in an app on a tablet
Traditional paper-based consent
Patient/family will receive their study information and consent on a traditional paper form
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Children with existing vascular access
* Families who choose not to have topical anesthetic placed on their child's hands
* Children receiving anxiolytic premedication
* Children planned to undergo mask induction of anesthesia before IV placement.
2 Years
5 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
BC Children's Hospital Research Institute
OTHER
University of British Columbia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Matthias Görges, PhD
Associate Professor (Partner)
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Matthias Görges, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of British Columbia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
BC Children ' s Hospital
Vancouver, British Columbia, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Lalloo C, Pham Q, Cafazzo J, Stephenson E, Stinson J. A ResearchKit app to deliver paediatric electronic consent: Protocol of an observational study in adolescents with arthritis. Contemp Clin Trials Commun. 2020 Jan 14;17:100525. doi: 10.1016/j.conctc.2020.100525. eCollection 2020 Mar.
Blake K, Holbrook JT, Antal H, Shade D, Bunnell HT, McCahan SM, Wise RA, Pennington C, Garfinkel P, Wysocki T. Use of mobile devices and the internet for multimedia informed consent delivery and data entry in a pediatric asthma trial: Study design and rationale. Contemp Clin Trials. 2015 May;42:105-18. doi: 10.1016/j.cct.2015.03.012. Epub 2015 Apr 3.
Seltzer E, Goldshear J, Guntuku SC, Grande D, Asch DA, Klinger EV, Merchant RM. Patients' willingness to share digital health and non-health data for research: a cross-sectional study. BMC Med Inform Decis Mak. 2019 Aug 8;19(1):157. doi: 10.1186/s12911-019-0886-9.
Adjekum A, Blasimme A, Vayena E. Elements of Trust in Digital Health Systems: Scoping Review. J Med Internet Res. 2018 Dec 13;20(12):e11254. doi: 10.2196/11254.
Miller CK, O'Donnell DC, Searight HR, Barbarash RA. The Deaconess Informed Consent Comprehension Test: an assessment tool for clinical research subjects. Pharmacotherapy. 1996 Sep-Oct;16(5):872-8.
Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. Quality of informed consent: a new measure of understanding among research subjects. J Natl Cancer Inst. 2001 Jan 17;93(2):139-47. doi: 10.1093/jnci/93.2.139.
Sugarman J, Lavori PW, Boeger M, Cain C, Edsond R, Morrison V, Yeh SS. Evaluating the quality of informed consent. Clin Trials. 2005;2(1):34-41. doi: 10.1191/1740774505cn066oa.
Related Links
Access external resources that provide additional context or updates about the study.
Pediatric Anesthesia Research Team website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H22-01928b
Identifier Type: -
Identifier Source: org_study_id