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Completed

NCT Number: NCT00453544

Enhancing Consent for Alzheimer's Research

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Veterans Affairs San Diego Healthcare System

San Diego, California, 92161, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced Consent Procedure

Other

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

Routine Consent Procedure

Other

This is a procedure designed to be in accord with standard research consent practices (and lacks multimedia aids)

Primary outcomes

  1. Level of Understanding

    Time frame: Within session - administered approximately 2-3 minutes after completion of the simulated consent process.

    Modified version of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) Understanding subscale.

    Minimum value = 0, Maximum value = 26; higher scores represent better performance

  2. Appreciation

    Time frame: Within session - immediately following administration of the MacCAT-CR Understanding subscale

    MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) Appreciation subscale Minimum score = 0, Maximum Score = 6; Higher scores represent better understanding

  3. Reasoning

    Time frame: Within session-immediately following administration of the MacCAT-CR Appreciation subscale

    Reasoning subscale of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) Minimum score = 0; Maximum Score = 8; Higher scores mean better reasoning capacity

  4. Expression of a Choice

    Time frame: Within session--immediately following administration of the MacCAT-CR Reasoning subscale

    Expression of a Choice subscale of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR); Minimum score = 0, Maximum score = 2; higher scores represent more intact ability to express a clear choice

Secondary outcomes

  1. Level of Satisfaction With Consent Process

    Time frame: Within session

    Question - "The consent process was" rated from "Very easy" to "Very Hard"

    • Very Easy
    • Easy
    • No effect
    • Hard
    • Very hard Higher scores mean more difficult (less satisfaction) with the consent process
    • with 1 being "Very Easy" and 5 being "Very hard"

  2. Expressed Willingness to Participate in the Hypothetical Protocol

    Time frame: Within session-last item of the Expression of a Choice Subscale, which itself was measured immediately after the MacCAT-CR Reasoning subscale

    Question about willingness to consent in the protocol described 0 = No

    • = Yes
    • = Unsure

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: BWP-AD

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Mar 29, 2007
Registry last updated
Jun 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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