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Comparing Paper-based and Tablet-delivered Informed Consent for Older Adults

Comparing Paper-based and Tablet-delivered Informed Consent for Older Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02114970
Enrollment
40
Registered
2014-04-15
Start date
2012-06-30
Completion date
2014-11-30
Last updated
2016-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paper-based Informed Consent, Tablet-delivered Informed Consent

Keywords

Older Adults, Informed Consent, Technology, Tablet-delivered

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.

Interventions

OTHERRandomized- paper consent
OTHERRandomized- Tablet-delivered consent
OTHERFocus Group- paper and tablet consent

Sponsors

Weill Medical College of Cornell University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
University of California San Diego Brief Assessment of Capacity to Consent (UBACC)immediately following intervention

Secondary

MeasureTime frame
study-specific measure of user-friendliness consent processimmediately following intervention
UBACCOne week following intervention

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026