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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tablet-delivered Informed Consent Paper-based Informed Consent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type OTHER

Focus Group- paper and tablet consent

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Randomized- paper consent

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Randomized- Tablet-delivered consent

Intervention Type OTHER

Interventions

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Randomized- paper consent

Intervention Type OTHER

Randomized- Tablet-delivered consent

Intervention Type OTHER

Focus Group- paper and tablet consent

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes