Informed ConsentECONSENTNCT02799407
Electronic Consent of Numerous Subjects Employing Novel Techniques Trial
A study testing ResearchKit Consent in people with Informed Consent, run by Duke University.
Trial summary
The purpose of this study is to compare the modular, multi-tiered consent process featured in Apple's ResearchKit (RK) to the standard consent process. The primary objective is to determine whether participants using the ResearchKit consent form have a significantly higher comprehension of the elements of consent than… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Informed Consent
- What is being tested?
- ResearchKit Consent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2018to 1 Aug 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Able to read and understand study materials which are presented in English
- Owns or has access to a smartphone or other smart device such as a tablet or iPod
Who cannot join
- Any physical limitations which prevent the participant from using mobile and/or touch screen technologies
- Employed in a research position, clinical care position, or position which has regular exposure to clinical research
About this study
The purpose of this study is to compare the modular, multi-tiered consent process featured in Apple's ResearchKit (RK) to the standard consent process. The primary objective is to determine whether participants using the ResearchKit consent form have a significantly higher comprehension of the elements of consent than participants using the standard consent form.
Read the detailed description
The purpose of this study is to compare the modular, multi-tiered consent process featured in Apple's ResearchKit (RK) to the standard consent process. The primary objective is to determine whether participants using the ResearchKit consent form have a significantly higher comprehension of the elements of consent than participants using the standard consent form. Through this two-arm randomized controlled trial (RCT) 120 participants will be asked to read through either a ResearchKit multi-tiered consent form administered on an iPod Touch device or a standard long-form consent form administered via paper and give their informed consent for a sham research study on health tracking apps. The participants will then be asked to answer a short series of questions (5 minutes) about the consent process in order to measure their subjective and objective comprehension. The main risk from this study is loss of confidentiality of responses, however this risk should be minimal given that protected health information (PHI) will only be collected on the consent document and all information will be stored on Duke Box in a private folder only accessible by the study team.
- Conditions
- Informed Consent
- Being tested
- ResearchKit Consent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResearchKit ConsentOther
Multi-tiered consent form using the Apple ResearchKit Platform.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Long Form Consent | No intervention | Participants will receive the traditional long-form consent form. |
| ResearchKit Consent | Experimental | Participants will receive the Apple ResearchKit consent form. Receives: Other: ResearchKit Consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant comprehension, as measured by Qualtrics survey
Participants will complete a questionnaire about the consent form after reading through the consent which will assess their comprehension of the contents of the consent process.
Measured: at study conclusion, an average of 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study start1 Nov 2018 (estimated)
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Aug 2019 (estimated)
Why it stopped: Never initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Informed ConsentStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Tanaka, MD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799407
- Sponsor's protocol ID
- Pro00070430
- Acronym
- ECONSENT
- Status last verified
- May 2018
- First submitted
- 6 Jun 2016
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Consent of Numerous Subjects Employing Novel Techniques Trial
- ClinicalTrials.gov ID
- NCT02799407
- Acronym / sponsor ID
- ECONSENT / Pro00070430
- Conditions
- Informed Consent
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Never initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 14 Jun 2016 (estimated)
- 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.
The purpose of this study is to compare the modular, multi-tiered consent process featured in Apple's ResearchKit (RK) to the standard consent process. The primary objective is to determine whether participants using the ResearchKit consent form have a significantly higher comprehension of the elements of consent than participants using the standard consent form.
Detailed description
The purpose of this study is to compare the modular, multi-tiered consent process featured in Apple's ResearchKit (RK) to the standard consent process. The primary objective is to determine whether participants using the ResearchKit consent form have a significantly higher comprehension of the elements of consent than participants using the standard consent form. Through this two-arm randomized controlled trial (RCT) 120 participants will be asked to read through either a ResearchKit multi-tiered consent form administered on an iPod Touch device or a standard long-form consent form administered via paper and give their informed consent for a sham research study on health tracking apps. The participants will then be asked to answer a short series of questions (5 minutes) about the consent process in order to measure their subjective and objective comprehension. The main risk from this study is loss of confidentiality of responses, however this risk should be minimal given that protected health information (PHI) will only be collected on the consent document and all information will be stored on Duke Box in a private folder only accessible by the study team.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Long Form Consent | No intervention | –Participants will receive the traditional long-form consent form. |
| ResearchKit Consent | Experimental | Other: ResearchKit ConsentParticipants will receive the Apple ResearchKit consent form. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years
- Able to read and understand study materials which are presented in English
- Owns or has access to a smartphone or other smart device such as a tablet or iPod
Key exclusion criteria (2 listed)
- Any physical limitations which prevent the participant from using mobile and/or touch screen technologies
- Employed in a research position, clinical care position, or position which has regular exposure to clinical research
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 |
|---|---|---|
| ResearchKit ConsentMulti-tiered consent form using the Apple ResearchKit Platform. | Other | ResearchKit Consent |
Primary outcome
Participant comprehension, as measured by Qualtrics survey
Time frame: at study conclusion, an average of 15 minutes
Participants will complete a questionnaire about the consent form after reading through the consent which will assess their comprehension of the contents of the consent process.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: No
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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.
David Tanaka, MD principal investigator
Duke Health
Questions about this trial
What is this clinical trial studying?
A study testing ResearchKit Consent in people with Informed Consent, run by Duke University.
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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Participant comprehension, as measured by Qualtrics survey (time frame: at study conclusion, an average of 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2024.