Comparison of Two Enhanced Consent Procedures for Patients With Mild Alzheimer Disease or Mild Cognitive Impairment

doi:10.1097/JGP.0b013e31802dd379

The American Journal of Geriatric Psychiatry

Volume 15, Issue 2, February 2007, Pages 163-167

https://doi.org/10.1097/JGP.0b013e31802dd379 Get rights and content

Objective

The objective of this study was to evaluate the feasibility, acceptability, and preliminary efficacy of two enhanced consent procedures provided to patients with Alzheimer disease or mild cognitive impairment that used either a PowerPoint presentation or an enhanced printed consent form.

Methods

Patients randomly assigned to an enhanced written consent procedure or slideshow presentation were assessed with the MacArthur Competence Assessment Tool for Clinical Research.

Results

Verbal reexplanation was associated with improved understanding in both conditions. Level of understanding did not significantly differ between the two consent groups, but administration time for slideshow presentation was less than that for an enhanced written consent procedure.

Conclusion

Enhanced consent procedures are feasible and useful for consent to research among patients with mild cognitive impairment or mild Alzheimer disease.

Section snippets

Participants

All participants provided written consent to participate in the (minimal risk and Institutional Review Board-approved) study. Participants were 35 consecutively referred patients with possible or probable mild AD (N = 19) or MCI (N = 16) who were receiving care at the University of Arkansas for Medical Sciences Alzheimer Disease Center or the Central Arkansas Veterans Healthcare System. Inclusion criteria were: 1) diagnosis of mild AD or MCI; 2) Mini-Mental State Examination (MMSE)⁸ score ≥19;

RESULTS

The mean age (and standard deviation) was 75.6 (7.8) years. A majority of the participants were men (57.1%), white (76.5%), and married (82.9%). The mean education was 14.5 (3.3) years, and MMSE and RBANS scores averaged 26.2 (3.4) and 79.29 (19.4), respectively. No significant differences were found between the two consent groups on any demographic or clinical characteristics (Table 1).

Among age, education, Geriatric Depression Scale, and total RBANS scores, only total RBANS scores contributed

DISCUSSION

As hypothesized, participants improved their understanding scores after verbal reexplanation of consent information. Contrary to our second hypothesis, there were no significant differences in level of understanding among those in the SSP versus EWCP conditions at either trial, but we found that the SSP took significantly less time to administer. Exploratory analyses suggested that the effects within the AD and MCI subsamples were similar to those observed for the combined sample; the only

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The actual work of accessing capacity is usually uncomplicated. Repeating information and breaking it up into manageable chunks or down to essentials may be all it takes to “activate” cognitively-limited patients.28,29 Doing so can render subjects with schizophrenia indistinguishable from controls on the MacArthur Competence Assessment Tool.30
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Dr. Mittal's work was supported in part by a US Department of Veterans Affairs (VA) South Central VA Health Care Network (VISN 16) Research Career Development Award. This study was supported in part by the University of Arkansas for Medical Sciences Alzheimer's Disease Center: National Institute on Aging (NIA) grant (5 P 30 AG 19606) and a grant (MH66248) from the National Institute of Mental Health (NIMH). It was also supported in part by the John A. Hartford Foundation's Center of Excellence in Geriatric Psychiatry at the University of California, San Diego. Dr. Palmer's contributions to this work were also supported in part by an NIMH grant (MH64722) and NIA grant (AG028827). Dr. Dunn was supported by NIMH Career Development Award (MH66062).

The authors thank Jill Davis, Debra Hollis, and Francis Hamilton for data collection.

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Brief ReportsComparison of Two Enhanced Consent Procedures for Patients With Mild Alzheimer Disease or Mild Cognitive Impairment

Objective

Methods

Results

Conclusion

Section snippets

Participants

RESULTS

DISCUSSION

Neuropsychopharmacology

Am J Geriatr Psychiatry

Assessing the competence of persons with Alzheimer's disease in providing informed consent for participation in research

Am J Psychiatry

Alzheimer's disease patients' and caregivers' capacity, competency, and reasons to enroll in an early-phase Alzheimer's disease clinical trial

J Am Geriatr Soc

Using a brief intervention to improve decisional capacity in schizophrenia research

Schizophr Bull

Brief Reports
Comparison of Two Enhanced Consent Procedures for Patients With Mild Alzheimer Disease or Mild Cognitive Impairment