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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG028827 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced consent - A | Experimental | The intervention was an enhanced consent process, including a multimedia aid for a moderate risk hypothetical protocol |
|
| Enhanced consent - B | Experimental | The intervention was an enhanced consent process, including multimedia aide for a higher risk hypothetical protocol |
|
| Routine consent - A | Active Comparator | This was a comparison condition - a routine consent process, including a printed consent document, for a moderate risk hypothetical protocol |
|
| Routine consent - B | Active Comparator | This was a comparison condition - a routine consent process, including a printed consent document, for a higher risk hypothetical protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Consent Procedure | Other | 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Level of Satisfaction With Consent Process | Question - "The consent process was" rated from "Very easy" to "Very Hard"
| Within session |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barton W. Palmer, PhD | UCSD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Affairs San Diego Healthcare System | San Diego | California | 92161 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11329391 | Background | Kim SY, Caine ED, Currier GW, Leibovici A, Ryan JM. Assessing the competence of persons with Alzheimer's disease in providing informed consent for participation in research. Am J Psychiatry. 2001 May;158(5):712-7. doi: 10.1176/appi.ajp.158.5.712. | |
| 15494623 | Background | Alzheimer's Association. Research consent for cognitively impaired adults: recommendations for institutional review boards and investigators. Alzheimer Dis Assoc Disord. 2004 Jul-Sep;18(3):171-5. doi: 10.1097/01.wad.0000137520.23370.56. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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) |
| FG003 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
259 subjects met inclusion/exclusion criteria, but 8 withdrew prior to the randomization (only two due to study - i.e. 2 found assessments too frustrating); 3 additional subjects had missing data key outcomes; resulting in 248 subjects in the final data analysis..
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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 | Posted | Mean | Standard Deviation | score on a scale (MacCAT-CR Und Trial 2) | Within session - administered approximately 2-3 minutes after completion of the simulated consent process. |
|
Adverse Events were not monitored/assessed.
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Barton Palmer | UC San Diego | 858-246-0765 | bpalmer@ucsd.edu |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Routine Consent Procedure | Other | 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 |
Question about willingness to consent in the protocol described 0 = No
|
| Within session-last item of the Expression of a Choice Subscale, which itself was measured immediately after the MacCAT-CR Reasoning subscale |
| 7053558 | Background | Kolata G. Alzheimer's research poses dilemma. Science. 1982 Jan 1;215(4528):47-8. doi: 10.1126/science.7053558. |
| 11331139 | Background | Dunn LB, Jeste DV. Enhancing informed consent for research and treatment. Neuropsychopharmacology. 2001 Jun;24(6):595-607. doi: 10.1016/S0893-133X(00)00218-9. |
| 28154452 | Result | Palmer BW, Harmell AL, Pinto LL, Dunn LB, Kim SY, Golshan S, Jeste DV. Determinants of Capacity to Consent to Research on Alzheimer's disease. Clin Gerontol. 2017;40(1):24-34. doi: 10.1080/07317115.2016.1197352. Epub 2016 Jun 7. |
| 29182458 | Result | Palmer BW, Harmell AL, Dunn LB, Kim SY, Pinto LL, Golshan S, Jeste DV. Multimedia Aided Consent for Alzheimer's Disease Research. Clin Gerontol. 2018 Jan-Feb;41(1):20-32. doi: 10.1080/07317115.2017.1373177. Epub 2017 Nov 28. |
| Primary outcome measure not completed |
|
| 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 |
| BG002 | 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) |
| BG003 | 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) |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | All participants were recruited and seen in the San Diego, CA metropolitan area. | Number | participants |
|
| OG001 | AD Enhanced Consent - Higher Risk | 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 |
| OG002 | AD Routine Consent - Mod Risk | 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) |
| OG003 | AD Routine Consent - Higher Risk | 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) |
| OG004 | NC Enhanced Consent - Mod Risk | 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 |
| OG005 | NC Enhanced Consent - Higher Risk | 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 |
| OG006 | NC Routine Consent - Mod Risk | 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) |
| OG007 | NC Routine Consent - Higher Risk | 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) |
|
|
| Primary | Appreciation | MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) Appreciation subscale Minimum score = 0, Maximum Score = 6; Higher scores represent better understanding | 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 | Posted | Mean | Standard Deviation | score on a scale | Within session - immediately following administration of the MacCAT-CR Understanding subscale |
|
|
|
| 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 | 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 | Posted | Mean | Standard Deviation | score on a scale | Within session-immediately following administration of the MacCAT-CR Appreciation subscale |
|
|
|
| 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 | 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 | Posted | Mean | Standard Deviation | units on a scale | Within session--immediately following administration of the MacCAT-CR Reasoning subscale |
|
|
|
| Secondary | Level of Satisfaction With Consent Process | Question - "The consent process was" rated from "Very easy" to "Very Hard"
| Administered immediately after the MacCAT-CR Expression of a Choice subscale | Posted | Mean | Standard Deviation | score on a scale | Within session |
|
|
|
| Secondary | Expressed Willingness to Participate in the Hypothetical Protocol | Question about willingness to consent in the protocol described 0 = No
| 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 | Posted | Number | percentage of yes | Within session-last item of the Expression of a Choice Subscale, which itself was measured immediately after the MacCAT-CR Reasoning subscale |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 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) | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | 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) | 0 | 0 | 0 | 0 | 0 | 0 |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |