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Memory Aid for Informed Consent in Alzheimer's Research

This study has been completed.
Information provided by National Institute on Aging (NIA)

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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.

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.

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
Intervention  Device: Memory and Organizational Aid
Behavioral: Standard Informed Consent Process
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:

  • Live within one hour drive of the University of Pennsylvania's Memory Disorders Clinic
  • Education equivalent to 6th grade level
  • Corrected visual acuity of at least 20/70
  • Speak English
  • Diagnosed with possible or probable AD, or non-demented
  • MMSE (Mini Mental State Exam) >= 18
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 
Principal Investigator:     Jason Karlawish, MD     University of Pennsylvania Institute on Aging    
Information Provided By National Institute on Aging (NIA)
Verification Date June 2008
First Received Date  March 15, 2005
Last Updated Date June 24, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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