Trial Outcomes & Findings for Enhancing Consent for Alzheimer's Research (NCT NCT00453544)
NCT ID: NCT00453544
Last Updated: 2023-06-06
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
252 participants
Primary outcome timeframe
Within session - administered approximately 2-3 minutes after completion of the simulated consent process.
Results posted on
2023-06-06
Participant Flow
Participant milestones
| Measure |
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
|
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
|
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)
|
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)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
62
|
55
|
68
|
67
|
|
Overall Study
COMPLETED
|
60
|
54
|
68
|
66
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
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
|
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
|
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)
|
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)
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Overall Study
Primary outcome measure not completed
|
1
|
1
|
0
|
1
|
Baseline Characteristics
Enhancing Consent for Alzheimer's Research
Baseline characteristics by cohort
| Measure |
Enhanced Consent - A
n=60 Participants
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
|
Enhanced Consent - B
n=54 Participants
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
|
Routine Consent - A
n=68 Participants
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)
|
Routine Consent - B
n=66 Participants
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)
|
Total
n=248 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
56 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
228 Participants
n=21 Participants
|
|
Age, Continuous
|
78.4 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
79.5 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
79.3 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
78.4 years
STANDARD_DEVIATION 8.5 • n=4 Participants
|
78.9 years
STANDARD_DEVIATION 8.4 • n=21 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
124 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
124 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
56 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
226 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
54 participants
n=7 Participants
|
68 participants
n=5 Participants
|
66 participants
n=4 Participants
|
248 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
AD Enhanced Consent - Mod Risk
n=26 Participants
Group = participants with mild-to-moderate AD
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
|
AD Enhanced Consent - Higher Risk
n=24 Participants
Group = participants with mild-to-moderate AD
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
|
AD Routine Consent - Mod Risk
n=33 Participants
Group = participants with mild-to-moderate AD
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)
|
AD Routine Consent - Higher Risk
n=31 Participants
Group = participants with mild-to-moderate AD
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)
|
NC Enhanced Consent - Mod Risk
n=34 Participants
Group = NC subjects
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
|
NC Enhanced Consent - Higher Risk
n=30 Participants
Group = NC subjects
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
|
NC Routine Consent - Mod Risk
n=35 Participants
Group = NC subjects
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)
|
NC Routine Consent - Higher Risk
n=35 Participants
Group = NC subjects
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)
|
|---|---|---|---|---|---|---|---|---|
|
Level of Understanding
|
17.8 score on a scale (MacCAT-CR Und Trial 2)
Standard Deviation 7.0
|
16.8 score on a scale (MacCAT-CR Und Trial 2)
Standard Deviation 7.6
|
15.1 score on a scale (MacCAT-CR Und Trial 2)
Standard Deviation 6.9
|
15.7 score on a scale (MacCAT-CR Und Trial 2)
Standard Deviation 7.7
|
25.2 score on a scale (MacCAT-CR Und Trial 2)
Standard Deviation 1.1
|
24.8 score on a scale (MacCAT-CR Und Trial 2)
Standard Deviation 2.2
|
25.3 score on a scale (MacCAT-CR Und Trial 2)
Standard Deviation 1.1
|
24.9 score on a scale (MacCAT-CR Und Trial 2)
Standard Deviation 2.3
|
PRIMARY outcome
Timeframe: Within session - immediately following administration of the MacCAT-CR Understanding subscalePopulation: 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
MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) Appreciation subscale Minimum score = 0, Maximum Score = 6; Higher scores represent better understanding
Outcome measures
| Measure |
AD Enhanced Consent - Mod Risk
n=26 Participants
Group = participants with mild-to-moderate AD
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
|
AD Enhanced Consent - Higher Risk
n=24 Participants
Group = participants with mild-to-moderate AD
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
|
AD Routine Consent - Mod Risk
n=33 Participants
Group = participants with mild-to-moderate AD
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)
|
AD Routine Consent - Higher Risk
n=31 Participants
Group = participants with mild-to-moderate AD
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)
|
NC Enhanced Consent - Mod Risk
n=33 Participants
Group = NC subjects
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
|
NC Enhanced Consent - Higher Risk
n=30 Participants
Group = NC subjects
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
|
NC Routine Consent - Mod Risk
n=35 Participants
Group = NC subjects
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)
|
NC Routine Consent - Higher Risk
n=34 Participants
Group = NC subjects
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)
|
|---|---|---|---|---|---|---|---|---|
|
Appreciation
|
4.2 score on a scale
Standard Deviation 1.8
|
4.2 score on a scale
Standard Deviation 1.6
|
4.2 score on a scale
Standard Deviation 1.3
|
4.1 score on a scale
Standard Deviation 1.7
|
5.5 score on a scale
Standard Deviation 0.8
|
4.7 score on a scale
Standard Deviation 1.1
|
5.2 score on a scale
Standard Deviation 1.0
|
5.1 score on a scale
Standard Deviation 1.1
|
PRIMARY outcome
Timeframe: Within session-immediately following administration of the MacCAT-CR Appreciation subscalePopulation: 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
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
Outcome measures
| Measure |
AD Enhanced Consent - Mod Risk
n=26 Participants
Group = participants with mild-to-moderate AD
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
|
AD Enhanced Consent - Higher Risk
n=23 Participants
Group = participants with mild-to-moderate AD
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
|
AD Routine Consent - Mod Risk
n=33 Participants
Group = participants with mild-to-moderate AD
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)
|
AD Routine Consent - Higher Risk
n=30 Participants
Group = participants with mild-to-moderate AD
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)
|
NC Enhanced Consent - Mod Risk
n=34 Participants
Group = NC subjects
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
|
NC Enhanced Consent - Higher Risk
n=30 Participants
Group = NC subjects
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
|
NC Routine Consent - Mod Risk
n=35 Participants
Group = NC subjects
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)
|
NC Routine Consent - Higher Risk
n=34 Participants
Group = NC subjects
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)
|
|---|---|---|---|---|---|---|---|---|
|
Reasoning
|
6.9 score on a scale
Standard Deviation 1.5
|
6.2 score on a scale
Standard Deviation 2.5
|
5.6 score on a scale
Standard Deviation 2.5
|
6.3 score on a scale
Standard Deviation 2.4
|
7.6 score on a scale
Standard Deviation 0.7
|
7.5 score on a scale
Standard Deviation 0.8
|
7.3 score on a scale
Standard Deviation 1.3
|
7.5 score on a scale
Standard Deviation 0.9
|
PRIMARY outcome
Timeframe: Within session--immediately following administration of the MacCAT-CR Reasoning subscalePopulation: 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
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
Outcome measures
| Measure |
AD Enhanced Consent - Mod Risk
n=26 Participants
Group = participants with mild-to-moderate AD
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
|
AD Enhanced Consent - Higher Risk
n=23 Participants
Group = participants with mild-to-moderate AD
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
|
AD Routine Consent - Mod Risk
n=33 Participants
Group = participants with mild-to-moderate AD
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)
|
AD Routine Consent - Higher Risk
n=30 Participants
Group = participants with mild-to-moderate AD
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)
|
NC Enhanced Consent - Mod Risk
n=34 Participants
Group = NC subjects
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
|
NC Enhanced Consent - Higher Risk
n=30 Participants
Group = NC subjects
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
|
NC Routine Consent - Mod Risk
n=35 Participants
Group = NC subjects
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)
|
NC Routine Consent - Higher Risk
n=34 Participants
Group = NC subjects
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)
|
|---|---|---|---|---|---|---|---|---|
|
Expression of a Choice
|
1.8 units on a scale
Standard Deviation 0.6
|
1.7 units on a scale
Standard Deviation 0.7
|
1.7 units on a scale
Standard Deviation 0.6
|
1.5 units on a scale
Standard Deviation 0.8
|
1.9 units on a scale
Standard Deviation 0.2
|
2.0 units on a scale
Standard Deviation 0.0
|
1.9 units on a scale
Standard Deviation 0.2
|
1.9 units on a scale
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Within sessionPopulation: Administered immediately after the MacCAT-CR Expression of a Choice subscale
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"
Outcome measures
| Measure |
AD Enhanced Consent - Mod Risk
n=20 Participants
Group = participants with mild-to-moderate AD
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
|
AD Enhanced Consent - Higher Risk
n=15 Participants
Group = participants with mild-to-moderate AD
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
|
AD Routine Consent - Mod Risk
n=24 Participants
Group = participants with mild-to-moderate AD
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)
|
AD Routine Consent - Higher Risk
n=21 Participants
Group = participants with mild-to-moderate AD
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)
|
NC Enhanced Consent - Mod Risk
n=33 Participants
Group = NC subjects
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
|
NC Enhanced Consent - Higher Risk
n=30 Participants
Group = NC subjects
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
|
NC Routine Consent - Mod Risk
n=34 Participants
Group = NC subjects
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)
|
NC Routine Consent - Higher Risk
n=32 Participants
Group = NC subjects
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)
|
|---|---|---|---|---|---|---|---|---|
|
Level of Satisfaction With Consent Process
|
1.3 score on a scale
Standard Deviation 2.1
|
2.4 score on a scale
Standard Deviation 1.9
|
2.0 score on a scale
Standard Deviation 2.1
|
1.9 score on a scale
Standard Deviation 2.1
|
1.9 score on a scale
Standard Deviation 0.9
|
1.8 score on a scale
Standard Deviation 0.6
|
1.7 score on a scale
Standard Deviation 0.6
|
1.7 score on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Within session-last item of the Expression of a Choice Subscale, which itself was measured immediately after the MacCAT-CR Reasoning subscalePopulation: 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
Question about willingness to consent in the protocol described 0 = No 1. = Yes 2. = Unsure
Outcome measures
| Measure |
AD Enhanced Consent - Mod Risk
n=25 Participants
Group = participants with mild-to-moderate AD
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
|
AD Enhanced Consent - Higher Risk
n=24 Participants
Group = participants with mild-to-moderate AD
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
|
AD Routine Consent - Mod Risk
n=31 Participants
Group = participants with mild-to-moderate AD
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)
|
AD Routine Consent - Higher Risk
n=31 Participants
Group = participants with mild-to-moderate AD
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)
|
NC Enhanced Consent - Mod Risk
n=33 Participants
Group = NC subjects
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
|
NC Enhanced Consent - Higher Risk
n=30 Participants
Group = NC subjects
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
|
NC Routine Consent - Mod Risk
n=35 Participants
Group = NC subjects
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)
|
NC Routine Consent - Higher Risk
n=33 Participants
Group = NC subjects
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)
|
|---|---|---|---|---|---|---|---|---|
|
Expressed Willingness to Participate in the Hypothetical Protocol
|
76 percentage of yes
|
83 percentage of yes
|
81 percentage of yes
|
71 percentage of yes
|
79 percentage of yes
|
67 percentage of yes
|
54 percentage of yes
|
56 percentage of yes
|
Adverse Events
Enhanced Consent - A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Consent - B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Routine Consent - A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Routine Consent - B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place