A Memory and Organizational Aid Improves Research 4.21.08
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1) The study aimed to determine if a one-page memory and organizational aid could improve the capacity of Alzheimer's patients to provide informed consent for clinical trials. 2) Alzheimer's patients were randomly assigned to either receive the standard consent process or the standard process plus the one-page memory aid. 3) Experts independently judged those who received the memory aid to be more capable of providing informed consent, with a higher percentage deemed competent compared to the control group.
![A memory and organizational aid improves research consent capacity in persons with Alzheimer’s disease Jason Karlawish MD 1,2,6,7,8,9,10 , Jonathan D Rubright BA 1,8,9 , Pamela Sankar PhD 2,7,10 , David J Casarett MD 1,7,8,10,11 , Ruben Gur PhD 3,4,5,8 , Sharon Xie PhD 6,9 University of Pennsylvania, Departments of Medicine 1 , Medical Ethics 2 , Psychiarty 3 , Radiology 4 , and Neurology 5 , Center for Clinical Epidemiology and Biostatistics 6 , Center for Bioethics 7 , Institute on Aging 8 , Alzheimer’s Disease Center 9 , Leonard David Institute of Health Economics 10 ; Philadelphia Veterans Affairs Center for Health Equity Research and Promotion 11 The research reported on this poster was supported by NIH R01-AG020627. The investigators retained full independence in the conduct of this research. BACKGROUND OBJECTIVE METHODS SUMMARY RESULTS ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],To demonstrate whether a memory and organizational aid improves AD patient performance on measures of capacity and competency to give informed consent. No difference between AD control and intervention groups by age (t=1.13, p=0.26), education (t=1.26, p=0.21), or MMSE (t=0.44, p-0.66). Chi2=8.2, p=0.004. Logistic regression CI 1.5-11.9, p=0.006. ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],MEMORY AID ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],t-test p<0.05. THEORY ,[object Object],[object Object],[object Object],[object Object],Table 3. Consensus consent ability by intervention. Control Intervention Total Incapable 33 21 54 Capable 7 19 26 Total 40 40 80 Table 1. Subject characteristics. AD intervention (n=40) AD control (n=40) Sex Female Male 17 (43%) 23 (58%) 23 (58%) 17 (43%) Age 74.4 + 9.5 (45-92) 76.5 + 6.6 (59-89) Race Caucasian Black 34 (85%) 6 (15%) 36 (90%) 4 (10%) Education 14.4 + 3.3 (7-21) 15.3 + 3.1 (10-22) MMSE 23.3 + 2.7 (18-28) 23.6 + 2.9 (18-28) Table 2. MacCAT-CR decision-making abilities by intervention. AD intervention (n=40) AD control (n=40) Understanding 17.6 + 5.6 (5-26)* 13.7+6.1 (2-25) Appreciation 3.5 + 1.8 (0-6)* 2.8+1.5 (0-6) Reasoning 6.3 + 1.7 (2-8) 5.7+2.5 (0-8) Choice 1.8 + 0.5 (0-2) 1.7+0.6 (0-2)](https://image.slidesharecdn.com/karlawishjason-amemoryandorganizationalaidimprovesresearch-4-21-08-2-100818145934-phpapp01/85/A-Memory-and-Organizational-Aid-Improves-Research-4-21-08-1-320.jpg)
