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

August 13, 2016 updated by: Nimali Jayasinghe, Weill Medical College of Cornell University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Weill Medical College of Cornell University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Other: Focus Group- paper and tablet consent
Active Comparator: 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.
Other: Randomized- paper consent
Active Comparator: 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.
Other: Randomized- Tablet-delivered consent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
University of California San Diego Brief Assessment of Capacity to Consent (UBACC)
Time Frame: immediately following intervention
immediately following intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
study-specific measure of user-friendliness consent process
Time Frame: immediately following intervention
immediately following intervention
UBACC
Time Frame: One week following intervention
One week following intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Nimali Jayasinghe, Ph.D., Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

April 10, 2014

First Submitted That Met QC Criteria

April 12, 2014

First Posted (Estimate)

April 15, 2014

Study Record Updates

Last Update Posted (Estimate)

August 16, 2016

Last Update Submitted That Met QC Criteria

August 13, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1401014708

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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