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

June 2, 2023 updated by: Barton W. Palmer, Ph.D., University of California, San Diego
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

252

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92161
        • Veterans Affairs San Diego Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within session - administered approximately 2-3 minutes after completion of the simulated consent process.
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
Within session - immediately following administration of the MacCAT-CR Understanding subscale
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
Within session-immediately following administration of the MacCAT-CR Appreciation subscale
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
Within session--immediately following administration of the MacCAT-CR Reasoning subscale

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of Satisfaction With Consent Process
Time Frame: Within session

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

  1. Very Easy
  2. Easy
  3. No effect
  4. Hard

  5. Very hard Higher scores mean more difficult (less satisfaction) with the consent process

    • with 1 being "Very Easy" and 5 being "Very hard"
Within session
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

  1. = Yes
  2. = Unsure
Within session-last item of the Expression of a Choice Subscale, which itself was measured immediately after the MacCAT-CR Reasoning subscale

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Barton W. Palmer, PhD, UCSD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

March 28, 2007

First Submitted That Met QC Criteria

March 28, 2007

First Posted (Estimated)

March 29, 2007

Study Record Updates

Last Update Posted (Actual)

June 6, 2023

Last Update Submitted That Met QC Criteria

June 2, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IA0110
  • 1R01AG028827 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alzheimer Disease

Clinical Trials on Enhanced Consent Procedure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe