App-based Consent for Pediatric Clinical Research (ConsentApp)

August 30, 2023 updated by: Matthias Görges, PhD, University of British Columbia

App-based Consent for Participation in Pediatric Clinical Research: a Feasibility Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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:

  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.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Nicholas C West, MSc
  • Phone Number: 604-875-2711
  • Email: nwest@bcchr.ca

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3N1
        • Recruiting
        • BC Children ' s Hospital
        • Contact:
          • Matthias Görges, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: App-based consent
Prototype consent app based on REDCap eConsent module
Device: Consent App
Family will receive their study information and consent form in an app on a tablet
Active Comparator: Traditional paper-based consent
Other: Traditional paper-based consent
Patient/family will receive their study information and consent on a traditional paper form

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of app-based consent versus paper-based consent
Time Frame: Immediately after consent is given for the study
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trust in the research consent process when using app-based consent versus paper-based consent
Time Frame: Immediately after consent is given for the study
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)
Immediately after consent is given for the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

BC Children's Hospital Research Institute

Investigators

  • Principal Investigator: Matthias Görges, PhD, The University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

May 10, 2023

First Submitted That Met QC Criteria

May 19, 2023

First Posted (Actual)

May 30, 2023

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 30, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H22-01928b

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

Details have yet to be determined.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Consent

Clinical Trials on Consent App

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe