Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Barton W. Palmer, Ph.D., University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00453544
First received: March 28, 2007
Last updated: October 26, 2016
Last verified: October 2016
  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
Other: Enhanced Consent Procedure
Other: Routine Consent Procedure

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

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Level of Understanding [ Time Frame: Within session ] [ Designated as safety issue: No ]
    Modified version of the MacCAT-CR Understanding subscale

  • Appreciation [ Time Frame: Immediate ] [ Designated as safety issue: No ]
    MacCAT-CR Appreciation subscale

  • Reasoning [ Time Frame: Within session ] [ Designated as safety issue: No ]
    MacCAT-CR Reasoning subscale

  • Expression of a Choice regarding hypothetical protocol [ Time Frame: Within session ] [ Designated as safety issue: No ]
    MacCAT-CR


Secondary Outcome Measures:
  • Level of Satisfaction with consent process [ Time Frame: Within session ] [ Designated as safety issue: No ]
    Questionnaire

  • Expressed willingness to participate in the hypothetical protocol [ Time Frame: Within session ] [ Designated as safety issue: No ]
    Question/interview


Enrollment: 252
Study Start Date: April 2006
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enhanced consent - A
The intervention was an enhanced consent process, including a multimedia aid for a moderate risk hypothetical protocol
Other: Enhanced Consent Procedure
This is a procedure involving use of multimedia materials, as well as standard review with research staff, to see if the research consent procedure can be improved
Experimental: Enhanced consent - B
The intervention was an enhanced consent process, including multimedia aide for a higher risk hypothetical protocol
Other: Enhanced Consent Procedure
This is a procedure involving use of multimedia materials, as well as standard review with research staff, to see if the research consent procedure can be improved
Active Comparator: Routine consent - A
This was a comparison condition - a routine consent process, including a printed consent document, for a moderate risk hypothetical protocol
Other: Routine Consent Procedure
This is a procedure designed to be in accord with standard research consent practices (and lacks multimedia aids)
Active Comparator: Routine consent - B
This was a comparison condition - a routine consent process, including a printed consent document, for a higher risk hypothetical protocol
Other: Routine Consent Procedure
This is a procedure designed to be in accord with standard research consent practices (and lacks multimedia aids)

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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00453544

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

Publications:
Responsible Party: Barton W. Palmer, Ph.D., Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00453544     History of Changes
Other Study ID Numbers: IA0110  1R01AG028827 
Study First Received: March 28, 2007
Last Updated: October 26, 2016
Health Authority: United States: Federal Government

Keywords provided by University of California, San Diego:
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
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on December 08, 2016