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

Not Applicable

Completed

• Conditions: Tablet-delivered Informed Consent; Paper-based Informed Consent
• Interventions: Other: Randomized- paper consent; Other: Randomized- Tablet-delivered consent; Other: Focus Group- paper and tablet consent

• Registration Number: NCT02114970
• Lead Sponsor: Weill Medical College of Cornell University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2014-04-10
• Study First Submitted QC: 2014-04-12
• Study First Posted: 2014-04-15
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-13
• Last Update Posted: 2016-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Randomized- paper consent	Randomized- paper consent	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.
Randomized- Tablet-delivered consent	Randomized- Tablet-delivered consent	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.
Focus Group- paper and tablet consent	Focus Group- paper and tablet consent	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.

Primary Outcome Measures

Name	Time	Method
University of California San Diego Brief Assessment of Capacity to Consent (UBACC)	immediately following intervention

Secondary Outcome Measures

Name	Time	Method
study-specific measure of user-friendliness consent process	immediately following intervention
UBACC	One week following intervention

Trial Locations

Locations (1)

Weill Medical College of Cornell University; 🇺🇸 New York, New York, United States