Enhancing Consent for Alzheimer's Research

Not Applicable

Completed

Interventions: Other: Routine Consent Procedure
Other: Enhanced Consent Procedure

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Clinical diagnosis of mild to moderate possible or probable AD or demographically comparable healthy comparison subjects
Fluency in English
50 yrs and older
Informed written consent (or written assent with consent from legally authorized representative)

Exclusion Criteria

Diagnosis of Lewy Body Dementia or Mild Cognitive Impairment
MMSE less than 15
Physical or medical conditions that preclude participants from completing tasks
Healthy comparison volunteers if they have a known neurologic or psychiatric condition that could impair neurocognitive functioning

Arm && Interventions

Group	Intervention	Description
Routine consent - A	Routine Consent Procedure	This was a comparison condition - a routine consent process, including a printed consent document, for a moderate risk hypothetical protocol
Enhanced consent - A	Enhanced Consent Procedure	The intervention was an enhanced consent process, including a multimedia aid for a moderate risk hypothetical protocol
Enhanced consent - B	Enhanced Consent Procedure	The intervention was an enhanced consent process, including multimedia aide for a higher risk hypothetical protocol
Routine consent - B	Routine Consent Procedure	This was a comparison condition - a routine consent process, including a printed consent document, for a higher risk hypothetical protocol

Primary Outcome Measures

Name	Time	Method
Appreciation	Within session - immediately following administration of the MacCAT-CR Understanding subscale	MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) Appreciation subscale Minimum score = 0, Maximum Score = 6; Higher scores represent better understanding
Level of Understanding	Within session - administered approximately 2-3 minutes after completion of the simulated consent process.	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
Reasoning	Within session-immediately following administration of the MacCAT-CR Appreciation subscale	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
Expression of a Choice	Within session--immediately following administration of the MacCAT-CR Reasoning subscale	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

Secondary Outcome Measures

Name	Time	Method
Level of Satisfaction With Consent Process	Within session	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"
Expressed Willingness to Participate in the Hypothetical Protocol	Within session-last item of the Expression of a Choice Subscale, which itself was measured immediately after the MacCAT-CR Reasoning subscale	Question about willingness to consent in the protocol described 0 = No 1. = Yes 2. = Unsure