Talk to the Veterans Crisis Line now
U.S. flag
An official website of the United States government

VA Health Systems Research

Go to the VA ORD website
Go to the QUERI website

HSR Citation Abstract

Search | Search by Center | Search by Source | Keywords in Title

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

Karlawish JH, Casarett DJ, James BD. Alzheimer's disease patients' and caregivers' capacity, competency, and reasons to enroll in an early-phase Alzheimer's disease clinical trial. Journal of the American Geriatrics Society. 2002 Dec 1; 50(12):2019-24.

Dimensions for VA is a web-based tool available to VA staff that enables detailed searches of published research and research projects.

If you have VA-Intranet access, click here for more information

VA staff not currently on the VA network can access Dimensions by registering for an account using their VA email address.
   Search Dimensions for VA for this citation
* Don't have VA-internal network access or a VA email address? Try searching the free-to-the-public version of Dimensions


OBJECTIVES: To examine the capacity, competency, and reasons for enrolling of patients with Alzheimer's disease (AD) and of their caregivers in an early phase AD clinical trial. DESIGN: Interviews were conducted with patients with AD, nondemented older persons, and caregivers. SETTING: Participants' homes. PARTICIPANTS: Fifteen patients with mild to moderate AD, 15 age- and education-matched nondemented older persons, and 15 patient caregivers. MEASUREMENTS: Capacity was measured using the MacArthur Competency Assessment Tool for Clinical Research (MacCAT-CR); a study coordinator who reviewed audiotapes of the capacity interviews judged competency, and the reasons for a decision were determined by coding the capacity interviews. RESULTS: On all measures except the ability to make a choice, patients performed worse than controls (understanding: z = 3.2, P = .001; appreciation: z = 2.8, P = .005; reasoning: z = 3.5, P = .0005), and caregivers (understanding: z = 3.8, P = .0002; appreciation: z = 3.0, P = .003; reasoning: z = 3.6, P = .0003). Using the controls' performance to set psychometric criteria to define capacity, the proportions of patients with adequate understanding, appreciation, and reasoning were six of 15 (40%), three of 15 (20%), and five of 15 (33%). All caregivers and nine of the 15 (60%) patients were competent. Reasons for enrolling typically featured the potential benefit to the patients' health or well-being and altruism that was expressed as a desire to help other patients and their families or a desire to contribute to scientific knowledge. CONCLUSIONS: The MacCAT-CR, in particular its understanding scale, is a reliable and valid way to assess patient capacity and competency to enroll in an early-phase clinical trial. Although many patients have significant impairments in their capacity, some mild-stage patients are competent. Reasons for enrolling in an early-phase trial blend an expectation of therapeutic benefit and a desire to help others.

Questions about the HSR website? Email the Web Team

Any health information on this website is strictly for informational purposes and is not intended as medical advice. It should not be used to diagnose or treat any condition.