Enhancing Consent for Alzheimer's Research

Study Overview
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Brief Summary
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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
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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.

Official Title
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Enhancing Consent for Alzheimer's Research

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Other: Enhanced Consent Procedure
* Other: Routine Consent Procedure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 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

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced consent - A<br>The intervention was an enhanced consent process, including a multimedia aid for a moderate risk hypothetical protocol | Other: Enhanced Consent Procedure<br>* 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<br>|
| Experimental: Enhanced consent - B<br>The intervention was an enhanced consent process, including multimedia aide for a higher risk hypothetical protocol | Other: Enhanced Consent Procedure<br>* 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<br>|
| Active Comparator: Routine consent - A<br>This was a comparison condition - a routine consent process, including a printed consent document, for a moderate risk hypothetical protocol | Other: Routine Consent Procedure<br>* This is a procedure designed to be in accord with standard research consent practices (and lacks multimedia aids)<br>|
| Active Comparator: Routine consent - B<br>This was a comparison condition - a routine consent process, including a printed consent document, for a higher risk hypothetical protocol | Other: Routine Consent Procedure<br>* This is a procedure designed to be in accord with standard research consent practices (and lacks multimedia aids)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | Within session--immediately following administration of the MacCAT-CR Reasoning subscale | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Satisfaction With Consent Process | Question - The consent process was rated from Very easy to Very Hard Very Easy Easy No effect Hard Very hard Higher scores mean more difficult (less satisfaction) with the consent process with 1 being Very Easy and 5 being Very hard | Within session | 
| Expressed Willingness to Participate in the Hypothetical Protocol | Question about willingness to consent in the protocol described 0 = No = Yes = Unsure | Within session-last item of the Expression of a Choice Subscale, which itself was measured immediately after the MacCAT-CR Reasoning subscale | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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computer assisted instruction, decision making, educational resource design /development, executive function