Enhancing Consent for Alzheimer's Research

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2012-09-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Enhanced consent - A

The intervention was an enhanced consent process, including a multimedia aid for a moderate risk hypothetical protocol

Group Type EXPERIMENTAL

Enhanced Consent Procedure

Intervention Type 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

Enhanced consent - B

The intervention was an enhanced consent process, including multimedia aide for a higher risk hypothetical protocol

Group Type EXPERIMENTAL

Enhanced Consent Procedure

Intervention Type 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 - A

This was a comparison condition - a routine consent process, including a printed consent document, for a moderate risk hypothetical protocol

Group Type ACTIVE_COMPARATOR

Routine Consent Procedure

Intervention Type OTHER

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

Routine consent - B

This was a comparison condition - a routine consent process, including a printed consent document, for a higher risk hypothetical protocol

Group Type ACTIVE_COMPARATOR

Routine Consent Procedure

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Routine Consent Procedure

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes