ConsentConsentAppNCT05880147
App-based Consent for Pediatric Clinical Research
A study testing Consent App and Traditional paper-based consent in people with Consent, run by University of British Columbia at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Consent
- What is being tested?
- Consent App and Traditional paper-based consent
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 27 Jul 2023to 24 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between the ages of 2 to 5 years who need an IV insertion in the medical imaging department.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- 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).
- The family will get 15 minutes to review the consent information privately.
- 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).
- 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
- Consent
- Being tested
- Consent App, Traditional paper-based consent
- Keywords
- Pediatric, Clinical research, App
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consent AppDevice
Family will receive their study information and consent form in an app on a tablet
Traditional paper-based consentOther
Patient/family will receive their study information and consent on a traditional paper form
| Study group | Role | What they receive |
|---|---|---|
| App-based consent | Experimental | Prototype consent app based on REDCap eConsent module Receives: Device: Consent App |
| Traditional paper-based consent | Active comparator | Traditional paper-based consent Receives: Other: Traditional paper-based consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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)
Measured: Immediately after consent is given for the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start27 Jul 2023
- Primary completion24 Jul 2024
- Study completion24 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ConsentStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open Label Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- BC Children's Hospital Research Institute
- Responsible party
- Principal investigator, Matthias Görges, PhD, University of British Columbia
- Investigators
- Matthias Görges, PhD, Principal investigator, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880147
- Sponsor's protocol ID
- H22-01928b
- Acronym
- ConsentApp
- Status last verified
- Dec 2024
- First submitted
- 10 May 2023
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 32211557Blake 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.
PubMed 25847579Seltzer 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.
PubMed 31395102Adjekum 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.
PubMed 30545807Miller 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.
PubMed 8888082Joffe 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.
PubMed 11208884Sugarman 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.
PubMed 16279577
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- App-based Consent for Participation in Pediatric Clinical Research: a Feasibility Study
- ClinicalTrials.gov ID
- NCT05880147
- Acronym / sponsor ID
- ConsentApp / H22-01928b
- Conditions
- Consent
- Keywords
- Pediatric, Clinical research, App
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- BC Children's Hospital Research Institute
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- 24 Jul 2024 (actual)
- Study completion
- 24 Jul 2024 (actual)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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).
- The family will get 15 minutes to review the consent information privately.
- 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).
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open Label Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| App-based consent | Experimental | Device: Consent AppPrototype consent app based on REDCap eConsent module |
| Traditional paper-based consent | Active comparator | Other: Traditional paper-based consentTraditional paper-based consent |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children between the ages of 2 to 5 years who need an IV insertion in the medical imaging department.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Consent AppFamily will receive their study information and consent form in an app on a tablet | Device | App-based consent |
| Traditional paper-based consentPatient/family will receive their study information and consent on a traditional paper form | Other | Traditional paper-based consent |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Background: PubMed 32211557Lalloo 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.
- Background: PubMed 25847579Blake 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.
- Background: PubMed 31395102Seltzer 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.
- Background: PubMed 30545807Adjekum 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.
- Background: PubMed 8888082Miller 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.
- Background: PubMed 11208884Joffe 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.
- Background: PubMed 16279577Sugarman 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.
- Pediatric Anesthesia Research Team websiteLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Görges, PhD principal investigator
The University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consent App and Traditional paper-based consent in people with Consent, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of app-based consent versus paper-based consent (time frame: Immediately after consent is given for the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05880147, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024; AzTrials last refreshed its copy on 1 Nov 2026.