Clinical trial NCT02114970: Comparing Paper-based and Tablet-delivered Informed Consent for Older Adults
Official title: Comparing Paper-based and Tablet-delivered Informed Consent for Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tablet-delivered Informed Consent
Paper-based Informed Consent
Keywords: Older Adults
Informed Consent
Technology
Tablet-delivered
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2014-04-15
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Age 65 years and older
* Cognitively intact
* Ability to speak and read English

Exclusion Criteria:

* 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

Primary outcomes:
measure: University of California San Diego Brief Assessment of Capacity to Consent (UBACC)
timeFrame: immediately following intervention
Secondary outcomes:
measure: study-specific measure of user-friendliness consent process
timeFrame: immediately following intervention
measure: UBACC
timeFrame: One week following intervention
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Nimali Jayasinghe, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: