A memory and organizational aid improves Alzheimer disease research consent capacity: results of a randomized, controlled trial.
OBJECTIVE
Early and progressive cognitive impairments of patients with Alzheimer disease (AD) hinder their capacity to provide informed consent. Unfortunately, the limited research on techniques to improve capacity has shown mixed results. Therefore, the authors tested whether a memory and organizational aid improves the performance of patients with AD on measures of capacity and competency to give informed consent.


METHODS
Patients with AD randomly assigned to standard consent or standard plus a memory and organizational aid.


METHODS
Memory and organizational aid summarized the content of information mandated under the informed consent disclosure requirements of the Common Rule at a sixth grade reading level.


METHODS
Three psychiatrists without access to patient data independently reviewed MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) interview transcripts to judge whether the patient was capable of providing informed consent. The agreement of at least two of the three experts defined a participant as capable of providing informed consent. Secondary outcomes are MacCAT-CR measures of understanding, appreciation and reasoning, and comparison with cognitively normal older adult norms.


RESULTS
AD intervention and control groups were similar in terms of age, education, and cognitive status. The intervention group was more likely to be judged competent than control group and had higher scores on MacCAT-CR measure of understanding. The intervention had no effect on the measures of appreciation or reasoning.


CONCLUSIONS
A consent process that addresses the deficits in memory and attention of a patient with AD can improve capacity to give informed consent for early phase AD research. The results also validate the MacCAT-CR as an instrument to measure capacity, especially the understanding subscale.


BACKGROUND
ClinicalTrials.Gov#NCT00105612, http://clinicaltrials.gov/show/NCT00105612.
Rubright
Jonathan
J
Delaware Education Research and Development Center, University of Delaware School of Education, Newark, USA.
Sankar
Pamela
P
Casarett
David J
DJ
Gur
Ruben
R
Xie
Sharon X
SX
Karlawish
Jason
J
D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000523:psychology*; D003657:Decision Making; D005260:Female; D015577:Geriatric Assessment / Q000379:methods; D006801:Humans; D007258:Informed Consent / Q000523:psychology*; D008297:Male; D008569:Memory Disorders / Q000523:psychology*; D016743:Mental Competency / Q000523:psychology*; D008875:Middle Aged; D035842:Research Subjects / Q000523:psychology*
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