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

University of California San Diego

Status: Completed

Conditions: Alzheimer Disease

Treatments: Other: Routine Consent Procedure; Other: Enhanced Consent Procedure

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00453544

IA0110

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

Details and patient eligibility

About

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.

Full 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.

Enrollment: 252 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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252 participants in 4 patient groups

Enhanced consent - A

Experimental group

Description:

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

Treatment:

Other: Enhanced Consent Procedure

Enhanced consent - B

Experimental group

Description:

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

Treatment:

Other: Enhanced Consent Procedure

Routine consent - A

Active Comparator group

Description:

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

Treatment:

Other: Routine Consent Procedure

Routine consent - B

Active Comparator group

Description:

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

Treatment:

Other: Routine Consent Procedure