The purpose of this study is to evaluate the efficacy of an enhanced consent procedure for patients with mild-to-moderate Alzheimer disease, and to identify factors and patient characteristics that predict the degree to which enhanced consent is more beneficial than routine consent procedures.
Alzheimer disease can impair the capacity of patients to give informed consent for research participation. Studies of informed consent involving other patient populations suggest better understanding of consent-relevant information may be achieved through modifications in the consent delivery process, including incorporation of multimedia learning tools into the consent discussion. In the present study, participants with Alzheimer disease and age-comparable healthy participants will be randomly assigned to review a hypothetical research protocol via routine or enhanced consent procedures. Participants will also complete standard cognitive and other rating scales so that we can characterize the sample, as well as evaluate the degree to which specific characteristics may be associated with need for enhanced consent procedures. Advances in the methods to optimize the informed consent process should enable future research participants to make more fully informed decisions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
252
This is a procedure involving use of multimedia materials, as well as standard review with research staff, to see if the research consent procedure can be improved
This is a procedure designed to be in accord with standard research consent practices (and lacks multimedia aids)
Veterans Affairs San Diego Healthcare System
San Diego, California, United States
Level of Understanding
Modified version of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) Understanding subscale. Minimum value = 0, Maximum value = 26; higher scores represent better performance
Time frame: Within session - administered approximately 2-3 minutes after completion of the simulated consent process.
Appreciation
MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) Appreciation subscale Minimum score = 0, Maximum Score = 6; Higher scores represent better understanding
Time frame: Within session - immediately following administration of the MacCAT-CR Understanding subscale
Reasoning
Reasoning subscale of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) Minimum score = 0; Maximum Score = 8; Higher scores mean better reasoning capacity
Time frame: Within session-immediately following administration of the MacCAT-CR Appreciation subscale
Expression of a Choice
Expression of a Choice subscale of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR); Minimum score = 0, Maximum score = 2; higher scores represent more intact ability to express a clear choice
Time frame: Within session--immediately following administration of the MacCAT-CR Reasoning subscale
Level of Satisfaction With Consent Process
Question - "The consent process was" rated from "Very easy" to "Very Hard" 1. Very Easy 2. Easy 3. No effect 4. Hard 5. Very hard Higher scores mean more difficult (less satisfaction) with the consent process * with 1 being "Very Easy" and 5 being "Very hard"
Time frame: Within session
Expressed Willingness to Participate in the Hypothetical Protocol
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Question about willingness to consent in the protocol described 0 = No 1. = Yes 2. = Unsure
Time frame: Within session-last item of the Expression of a Choice Subscale, which itself was measured immediately after the MacCAT-CR Reasoning subscale