Alzheimer Disease
Conditions
Keywords
computer assisted instruction, decision making, educational resource design /development, executive function
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.
Interventions
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
OTHERRoutine Consent Procedure
This is a procedure designed to be in accord with standard research consent practices (and lacks multimedia aids)
Sponsors
National Institute on Aging (NIA)
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enhanced Consent - A The intervention was an enhanced consent process, including a multimedia aid for a moderate risk hypothetical protocol
Enhanced Consent Procedure: 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 | 60 |
| Enhanced Consent - B The intervention was an enhanced consent process, including multimedia aide for a higher risk hypothetical protocol
Enhanced Consent Procedure: 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 | 54 |
| Routine Consent - A This was a comparison condition - a routine consent process, including a printed consent document, for a moderate risk hypothetical protocol
Routine Consent Procedure: This is a procedure designed to be in accord with standard research consent practices (and lacks multimedia aids) | 68 |
| Routine Consent - B This was a comparison condition - a routine consent process, including a printed consent document, for a higher risk hypothetical protocol
Routine Consent Procedure: This is a procedure designed to be in accord with standard research consent practices (and lacks multimedia aids) | 66 |
| Total | 248 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Primary outcome measure not completed | 1 | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Enhanced Consent - B | Routine Consent - A | Enhanced Consent - A | Routine Consent - B |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 228 Participants | 51 Participants | 62 Participants | 56 Participants | 59 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 3 Participants | 6 Participants | 4 Participants | 7 Participants |
| Age, Continuous | 78.9 years STANDARD_DEVIATION 8.4 | 79.5 years STANDARD_DEVIATION 8.4 | 79.3 years STANDARD_DEVIATION 8.3 | 78.4 years STANDARD_DEVIATION 8.5 | 78.4 years STANDARD_DEVIATION 8.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 2 Participants | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 226 Participants | 49 Participants | 63 Participants | 56 Participants | 58 Participants |
| Region of Enrollment United States | 248 participants | 54 participants | 68 participants | 60 participants | 66 participants |
| Sex: Female, Male Female | 124 Participants | 25 Participants | 31 Participants | 33 Participants | 35 Participants |
| Sex: Female, Male Male | 124 Participants | 29 Participants | 37 Participants | 27 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
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
Population: 114 people with Alzheimer's disease (AD); 132 non-neuropsychiatric comparison (NC) subjects; the effects of routine vs. enhanced consent and moderate vs. higher risk were analyzed within diagnostic groups separately
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AD Enhanced Consent - Mod Risk | Appreciation | 4.2 score on a scale | Standard Deviation 1.8 |
| AD Enhanced Consent - Higher Risk | Appreciation | 4.2 score on a scale | Standard Deviation 1.6 |
| AD Routine Consent - Mod Risk | Appreciation | 4.2 score on a scale | Standard Deviation 1.3 |
| AD Routine Consent - Higher Risk | Appreciation | 4.1 score on a scale | Standard Deviation 1.7 |
| NC Enhanced Consent - Mod Risk | Appreciation | 5.5 score on a scale | Standard Deviation 0.8 |
| NC Enhanced Consent - Higher Risk | Appreciation | 4.7 score on a scale | Standard Deviation 1.1 |
| NC Routine Consent - Mod Risk | Appreciation | 5.2 score on a scale | Standard Deviation 1 |
| NC Routine Consent - Higher Risk | Appreciation | 5.1 score on a scale | Standard Deviation 1.1 |
Primary
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
Population: 112 people with Alzheimer's disease (AD); 133 non-neuropsychiatric comparison (NC) subjects; the effects of routine vs. enhanced consent and moderate vs. higher risk were analyzed within diagnostic groups separately
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AD Enhanced Consent - Mod Risk | Expression of a Choice | 1.8 units on a scale | Standard Deviation 0.6 |
| AD Enhanced Consent - Higher Risk | Expression of a Choice | 1.7 units on a scale | Standard Deviation 0.7 |
| AD Routine Consent - Mod Risk | Expression of a Choice | 1.7 units on a scale | Standard Deviation 0.6 |
| AD Routine Consent - Higher Risk | Expression of a Choice | 1.5 units on a scale | Standard Deviation 0.8 |
| NC Enhanced Consent - Mod Risk | Expression of a Choice | 1.9 units on a scale | Standard Deviation 0.2 |
| NC Enhanced Consent - Higher Risk | Expression of a Choice | 2.0 units on a scale | Standard Deviation 0 |
| NC Routine Consent - Mod Risk | Expression of a Choice | 1.9 units on a scale | Standard Deviation 0.2 |
| NC Routine Consent - Higher Risk | Expression of a Choice | 1.9 units on a scale | Standard Deviation 0.3 |
Primary
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.
Population: 114 people with Alzheimer's disease (AD); 134 non-neuropsychiatric comparison (NC) subjects; the effects of routine vs. enhanced consent and moderate vs. higher risk were analyzed within diagnostic groups separately
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AD Enhanced Consent - Mod Risk | Level of Understanding | 17.8 score on a scale (MacCAT-CR Und Trial 2) | Standard Deviation 7 |
| AD Enhanced Consent - Higher Risk | Level of Understanding | 16.8 score on a scale (MacCAT-CR Und Trial 2) | Standard Deviation 7.6 |
| AD Routine Consent - Mod Risk | Level of Understanding | 15.1 score on a scale (MacCAT-CR Und Trial 2) | Standard Deviation 6.9 |
| AD Routine Consent - Higher Risk | Level of Understanding | 15.7 score on a scale (MacCAT-CR Und Trial 2) | Standard Deviation 7.7 |
| NC Enhanced Consent - Mod Risk | Level of Understanding | 25.2 score on a scale (MacCAT-CR Und Trial 2) | Standard Deviation 1.1 |
| NC Enhanced Consent - Higher Risk | Level of Understanding | 24.8 score on a scale (MacCAT-CR Und Trial 2) | Standard Deviation 2.2 |
| NC Routine Consent - Mod Risk | Level of Understanding | 25.3 score on a scale (MacCAT-CR Und Trial 2) | Standard Deviation 1.1 |
| NC Routine Consent - Higher Risk | Level of Understanding | 24.9 score on a scale (MacCAT-CR Und Trial 2) | Standard Deviation 2.3 |
Primary
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
Population: 112 people with Alzheimer's disease (AD); 133 non-neuropsychiatric comparison (NC) subjects; the effects of routine vs. enhanced consent and moderate vs. higher risk were analyzed within diagnostic groups separately
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AD Enhanced Consent - Mod Risk | Reasoning | 6.9 score on a scale | Standard Deviation 1.5 |
| AD Enhanced Consent - Higher Risk | Reasoning | 6.2 score on a scale | Standard Deviation 2.5 |
| AD Routine Consent - Mod Risk | Reasoning | 5.6 score on a scale | Standard Deviation 2.5 |
| AD Routine Consent - Higher Risk | Reasoning | 6.3 score on a scale | Standard Deviation 2.4 |
| NC Enhanced Consent - Mod Risk | Reasoning | 7.6 score on a scale | Standard Deviation 0.7 |
| NC Enhanced Consent - Higher Risk | Reasoning | 7.5 score on a scale | Standard Deviation 0.8 |
| NC Routine Consent - Mod Risk | Reasoning | 7.3 score on a scale | Standard Deviation 1.3 |
| NC Routine Consent - Higher Risk | Reasoning | 7.5 score on a scale | Standard Deviation 0.9 |
Secondary
Expressed Willingness to Participate in the Hypothetical Protocol
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
Population: 111 people with Alzheimer's disease (AD); 131 non-neuropsychiatric comparison (NC) subjects; the effects of routine vs. enhanced consent and moderate vs. higher risk were analyzed within diagnostic groups separately
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AD Enhanced Consent - Mod Risk | Expressed Willingness to Participate in the Hypothetical Protocol | 76 percentage of yes |
| AD Enhanced Consent - Higher Risk | Expressed Willingness to Participate in the Hypothetical Protocol | 83 percentage of yes |
| AD Routine Consent - Mod Risk | Expressed Willingness to Participate in the Hypothetical Protocol | 81 percentage of yes |
| AD Routine Consent - Higher Risk | Expressed Willingness to Participate in the Hypothetical Protocol | 71 percentage of yes |
| NC Enhanced Consent - Mod Risk | Expressed Willingness to Participate in the Hypothetical Protocol | 79 percentage of yes |
| NC Enhanced Consent - Higher Risk | Expressed Willingness to Participate in the Hypothetical Protocol | 67 percentage of yes |
| NC Routine Consent - Mod Risk | Expressed Willingness to Participate in the Hypothetical Protocol | 54 percentage of yes |
| NC Routine Consent - Higher Risk | Expressed Willingness to Participate in the Hypothetical Protocol | 56 percentage of yes |
Secondary
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
Population: Administered immediately after the MacCAT-CR Expression of a Choice subscale
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AD Enhanced Consent - Mod Risk | Level of Satisfaction With Consent Process | 1.3 score on a scale | Standard Deviation 2.1 |
| AD Enhanced Consent - Higher Risk | Level of Satisfaction With Consent Process | 2.4 score on a scale | Standard Deviation 1.9 |
| AD Routine Consent - Mod Risk | Level of Satisfaction With Consent Process | 2.0 score on a scale | Standard Deviation 2.1 |
| AD Routine Consent - Higher Risk | Level of Satisfaction With Consent Process | 1.9 score on a scale | Standard Deviation 2.1 |
| NC Enhanced Consent - Mod Risk | Level of Satisfaction With Consent Process | 1.9 score on a scale | Standard Deviation 0.9 |
| NC Enhanced Consent - Higher Risk | Level of Satisfaction With Consent Process | 1.8 score on a scale | Standard Deviation 0.6 |
| NC Routine Consent - Mod Risk | Level of Satisfaction With Consent Process | 1.7 score on a scale | Standard Deviation 0.6 |
| NC Routine Consent - Higher Risk | Level of Satisfaction With Consent Process | 1.7 score on a scale | Standard Deviation 0.6 |