Tablet-delivered Informed ConsentNCT02114970
Comparing Paper-based and Tablet-delivered Informed Consent for Older Adults
A study testing Randomized- paper consent, Randomized- Tablet-delivered consent and Focus Group- paper and tablet consent in people with Tablet-delivered Informed Consent and Paper-based Informed Consent, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The investigators will develop and test a tablet-delivered informed consent process. In a preliminary phase of the study, older adults will provide feedback on a prototype tablet-delivered consent by participating in a focus group. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tablet-delivered Informed Consent, Paper-based Informed Consent
- What is being tested?
- Randomized- paper consent, Randomized- Tablet-delivered consent and Focus Group- paper and tablet consent
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Nov 2014
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 65 years and older
- Cognitively intact
- Ability to speak and read English
Who cannot join
- Legal blindness
- Severe hearing loss not corrected by assistive device
- Inability to use hands to swipe a tablet's touch screen
- No working telephone in the home
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Medical College of Cornell University
New York, New York, 10065
About this study
The investigators will develop and test a tablet-delivered informed consent process. In a preliminary phase of the study, older adults will provide feedback on a prototype tablet-delivered consent by participating in a focus group. In a separate second phase, older adults will be randomly assigned to a tablet-delivered or paper-delivered consent condition in which their comprehension of material covered in the consent will be assessed.
Read the detailed description
Clinical research is crucial for advancing healthcare, but patients must be able to make informed and voluntary choices about whether or not to participate in a research study. The informed consent process aspires to convey the purpose of research, the procedures involved, and the potential harms and benefits of taking part. Yet, the challenge of making informed consent easy to follow and understand is great: there are specific challenges for older research populations.
This study will develop and test a tablet-delivered informed consent process. The study will have two phases.
In the first phase, focus groups comprised of older adults will give their impressions of both a prototype tablet-delivered and paper consent, and the prototype will be refined according to feedback.
The second phase will evaluate whether older subjects judge a tablet-delivered consent to be more user-friendly than a paper-based version. It will also evaluate whether older subjects who participate in a tablet-delivered consent process have a better understanding of the research than those who participate in the paper-based version, and whether they remember the research details more fully after a one-week delay.
- Being tested
- Randomized- paper consent, Randomized- Tablet-delivered consent, Focus Group- paper and tablet consent
- Keywords
- Older Adults, Informed Consent, Technology, Tablet-delivered
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Randomized- paper consentOther
Randomized- Tablet-delivered consentOther
Focus Group- paper and tablet consentOther
| Study group | Role | What they receive |
|---|---|---|
| Focus Group- paper and tablet consent | Other | Participation in a focus group of other older adults, lasting 120 minutes. Participants will answer semi-structured questions in a group format, describing their impressions of both a prototype tablet-delivered and a paper consent. Receives: Other: Focus Group- paper and tablet consent |
| Randomized- paper consent | Active comparator | Participants will review a mock paper consent form with a study clinician, and complete a series of questionnaires assessing their comprehension of material covered and general experience with the paper informed consent form. Receives: Other: Randomized- paper consent |
| Randomized- Tablet-delivered consent | Active comparator | Participants will review a mock tablet-delivered consent form with a study clinician, and complete a series of questionnaires assessing their comprehension of material covered and general experience with the tablet-delivered informed consent. Receives: Other: Randomized- Tablet-delivered consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
University of California San Diego Brief Assessment of Capacity to Consent (UBACC)
Measured: immediately following intervention
Secondary outcomes (2)
study-specific measure of user-friendliness consent process
Measured: immediately following intervention
UBACC
Measured: One week following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startJun 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tablet-delivered Informed ConsentStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nimali Jayasinghe, Weill Medical College of Cornell University
- Investigators
- Nimali Jayasinghe, Ph.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114970
- Sponsor's protocol ID
- 1401014708
- Status last verified
- Aug 2016
- First submitted
- 10 Apr 2014
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Paper-based and Tablet-delivered Informed Consent for Older Adults
- ClinicalTrials.gov ID
- NCT02114970
- Acronym / sponsor ID
- 1401014708
- Keywords
- Older Adults, Informed Consent, Technology, Tablet-delivered
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 15 Apr 2014 (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 investigators will develop and test a tablet-delivered informed consent process. In a preliminary phase of the study, older adults will provide feedback on a prototype tablet-delivered consent by participating in a focus group. In a separate second phase, older adults will be randomly assigned to a tablet-delivered or paper-delivered consent condition in which their comprehension of material covered in the consent will be assessed.
Detailed description
Clinical research is crucial for advancing healthcare, but patients must be able to make informed and voluntary choices about whether or not to participate in a research study. The informed consent process aspires to convey the purpose of research, the procedures involved, and the potential harms and benefits of taking part. Yet, the challenge of making informed consent easy to follow and understand is great: there are specific challenges for older research populations.
This study will develop and test a tablet-delivered informed consent process. The study will have two phases.
In the first phase, focus groups comprised of older adults will give their impressions of both a prototype tablet-delivered and paper consent, and the prototype will be refined according to feedback.
The second phase will evaluate whether older subjects judge a tablet-delivered consent to be more user-friendly than a paper-based version. It will also evaluate whether older subjects who participate in a tablet-delivered consent process have a better understanding of the research than those who participate in the paper-based version, and whether they remember the research details more fully after a one-week delay.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Focus Group- paper and tablet consent | Other | Other: Focus Group- paper and tablet consentParticipation in a focus group of other older adults, lasting 120 minutes. Participants will answer semi-structured questions in a group format, describing their impressions of both a prototype tablet-delivered and a paper consent. |
| Randomized- paper consent | Active comparator | Other: Randomized- paper consentParticipants will review a mock paper consent form with a study clinician, and complete a series of questionnaires assessing their comprehension of material covered and general experience with the paper informed consent form. |
| Randomized- Tablet-delivered consent | Active comparator | Other: Randomized- Tablet-delivered consentParticipants will review a mock tablet-delivered consent form with a study clinician, and complete a series of questionnaires assessing their comprehension of material covered and general experience with the tablet-delivered informed consent. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age 65 years and older
- Cognitively intact
- Ability to speak and read English
Key exclusion criteria (4 listed)
- Legal blindness
- Severe hearing loss not corrected by assistive device
- Inability to use hands to swipe a tablet's touch screen
- No working telephone in the home
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 |
|---|---|---|
| Randomized- paper consent | Other | Randomized- paper consent |
| Randomized- Tablet-delivered consent | Other | Randomized- Tablet-delivered consent |
| Focus Group- paper and tablet consent | Other | Focus Group- paper and tablet consent |
Primary outcome
University of California San Diego Brief Assessment of Capacity to Consent (UBACC)
Time frame: immediately following intervention
2 secondary outcomes
study-specific measure of user-friendliness consent process
Time frame: immediately following intervention
UBACC
Time frame: One week following intervention
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 16 Aug 2016.
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.
Nimali Jayasinghe, Ph.D. principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Randomized- paper consent, Randomized- Tablet-delivered consent and Focus Group- paper and tablet consent in people with Tablet-delivered Informed Consent and Paper-based Informed Consent, run by Weill Medical College of Cornell University at 1 site in United States.
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 4 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 16 Aug 2016. 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 United States. 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?
University of California San Diego Brief Assessment of Capacity to Consent (UBACC) (time frame: immediately following intervention). 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 16 Aug 2016.