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| Descriptive Information Fields | |||||
| Brief Title † | Memory Aid for Informed Consent in Alzheimer's Research | ||||
| Official Title † | Improving Informed Consent in Alzheimer's Disease Research | ||||
| Brief Summary | The purpose of this trial is to test whether a memory and organizational aid in the form of a document that summarizes and simplifies a study's key points can improve the decision-making abilities and competency of mild to early moderate Alzheimer's disease (AD) patients. |
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| Detailed Description | Studies of mild to moderate Alzheimer's disease (AD) patients reveal substantial variation in their ability to participate in an informed consent process. No published data show techniques that help an AD patient to participate in an informed consent. This research will address this issue by performing a randomized trial to test whether a memory and organizational aid can improve the decision-making abilities and competency of AD patients. This study will recruit 80 patients with mild to early moderate AD, and 30 non-demented elderly persons. The informed consent protocol for a hypothetical early-phase drug trial will be administered by a trained interviewer in the patient's home. The AD patients will be randomized to receive either the standard informed consent process or the intervention of the standard informed consent process plus the memory and organizational aid. All non-demented elderly individuals will receive the standard informed consent process. The interviewer will administer the protocol to participants and ask questions that will assess participant capacity to understand, appreciate, reason, and make a choice concerning enrollment in the hypothetical study. |
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| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Other, Randomized, Efficacy Study | ||||
| Primary Outcome Measure † | MacArthur Competency Assessment Tool for Clinical Research (MacCAT-CR) to quantify decision making abilities | ||||
| Secondary Outcome Measure † | |||||
| Condition † | Alzheimer's Disease Aging |
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| Intervention † | Device: Memory and Organizational Aid Behavioral: Standard Informed Consent Process |
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| MEDLINE PMIDs | 7575221, 11329391, 7955902, 12473015 | ||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 110 | ||||
| Start Date † | September 2004 | ||||
| Completion Date | March 2007 | ||||
| Eligibility Criteria † | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00105612 | ||||
| Organization ID | IA0070 | ||||
| Secondary IDs †† | 1R01AG020627-01A2 | ||||
| Study Sponsor † | National Institute on Aging (NIA) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Institute on Aging (NIA) | ||||
| Verification Date | June 2008 | ||||
| First Received Date † | March 15, 2005 | ||||
| Last Updated Date | June 24, 2008 | ||||