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

Study Overview
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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.

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.

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

Conditions
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Tablet-delivered Informed Consent, Paper-based Informed Consent

Intervention / Treatment
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* Other: Randomized- paper consent
* Other: Randomized- Tablet-delivered consent
* Other: Focus Group- paper and tablet consent


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Focus Group- paper and tablet consent<br>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<br> <br> |
| Active Comparator: Randomized- paper consent<br>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<br> <br> |
| Active Comparator: Randomized- Tablet-delivered consent<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Technology, Tablet-delivered, Older Adults, Informed Consent