App-based Consent for Pediatric Clinical Research

NCT05880147 | Completed

• 1 other identifier: H22-01928b
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Consent

Keywords

Pediatric; Clinical research; App

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately after consent is given for the study

Secondary Outcomes (1)

• Trust in the research consent process when using app-based consent versus paper-based consent

  Immediately after consent is given for the study

Study Arms (2)

App-based consent

EXPERIMENTAL

Prototype consent app based on REDCap eConsent module

Device: Consent App

Traditional paper-based consent

ACTIVE COMPARATOR

Traditional paper-based consent

Other: Traditional paper-based consent

Interventions

Consent App DEVICE

Family will receive their study information and consent form in an app on a tablet

App-based consent

Traditional paper-based consent OTHER

Patient/family will receive their study information and consent on a traditional paper form

Traditional paper-based consent

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children between the ages of 2 to 5 years who need an IV insertion in the medical imaging department.

You may not qualify if:

• Children who are nonverbal;
• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• BC Children's Hospital Research Institute: collaborator

Study Sites (1)

BC Children ' s Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

Related Publications (7)

• 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.

  PMID: 32211557 BACKGROUND

• 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.

  PMID: 25847579 BACKGROUND

• 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.

  PMID: 31395102 BACKGROUND

• 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.

  PMID: 30545807 BACKGROUND

• 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.

  PMID: 8888082 BACKGROUND

• 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.

  PMID: 11208884 BACKGROUND

• 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.

  PMID: 16279577 BACKGROUND

Related Links

• Pediatric Anesthesia Research Team website

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Matthias Görges, PhD

  The University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: As blinding is impossible, we will not conceal allocation from any members of the clinical or study teams.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor (Partner)

Model Details: Open Label Randomized Controlled Trial

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 30, 2023
• Study Start: July 27, 2023
• Primary Completion: July 24, 2024
• Study Completion: July 24, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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.

Locations

CA (1)