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Enhancing Consent for Alzheimer's Research (BWP-AD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by National Institute on Aging (NIA).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00453544
First received: March 28, 2007
Last updated: December 23, 2009
Last verified: December 2009
History of Changes
  Purpose

The purpose of this study is to evaluate the efficacy of an enhanced consent procedure for patients with mild-to-moderate Alzheimer disease, and to identify factors and patient characteristics that predict the degree to which enhanced consent is more beneficial than routine consent procedures.


Condition Intervention
Alzheimer Disease
 Procedure: Enhanced Consent Procedure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Official Title: Enhancing Consent for Alzheimer's Research

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • Level of Understanding
  • Appreciation
  • Reasoning
  • Expression of a Choice regarding hypothetical protocol

Secondary Outcome Measures:
  • Level of Satisfaction with consent process
  • Expressed willingness to participate in the hypothetical protocol

Estimated Enrollment: 272
Study Start Date: April 2006
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Detailed Description:

Alzheimer disease can impair the capacity of patients to give informed consent for research participation. Studies of informed consent involving other patient populations suggest better understanding of consent-relevant information may be achieved through modifications in the consent delivery process, including incorporation of multimedia learning tools into the consent discussion.

In the present study, participants with Alzheimer disease and age-comparable healthy participants will be randomly assigned to review a hypothetical research protocol via routine or enhanced consent procedures. Participants will also complete standard cognitive and other rating scales so that we can characterize the sample, as well as evaluate the degree to which specific characteristics may be associated with need for enhanced consent procedures. Advances in the methods to optimize the informed consent process should enable future research participants to make more fully informed decisions.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Clinical diagnosis of mild to moderate possible or probable AD or demographically comparable healthy comparison subjects
  • Fluency in English
  • 50 yrs and older
  • Informed written consent (or written assent with consent from legally authorized representative)

Exclusion Criteria:

  • Diagnosis of Lewy Body Dementia or Mild Cognitive Impairment
  • MMSE less than 15
  • Physical or medical conditions that preclude participants from completing tasks
  • Healthy comparison volunteers if they have a known neurologic or psychiatric condition that could impair neurocognitive functioning
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00453544

Contacts
Contact: Tia Thrasher, BA 858-535-5795 tthrasher@ucsd.edu
Contact: Luz Pinto, BS 858-642-3682 llpinto@ucsd.edu

Locations
United States, California
Veterans Affairs San Diego Healthcare System Recruiting
San Diego, California, United States, 92161
Sponsors and Collaborators
National Institute on Aging (NIA)
Investigators
Principal Investigator: Barton W. Palmer, PhD UCSD
  More Information

Publications:

Responsible Party: Barton W. Palmer, PhD, University of California, San Diego (UCSD)
ClinicalTrials.gov Identifier: NCT00453544     History of Changes
Other Study ID Numbers: IA0110, 1R01AG028827
Study First Received: March 28, 2007
Last Updated: December 23, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
computer assisted instruction
decision making
educational resource design /development
executive function

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013