Enhancing Consent for Alzheimer's Research (BWP-AD)
Recruitment status was Recruiting
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
|Official Title:||Enhancing Consent for Alzheimer's Research|
- Level of Understanding
- Expression of a Choice regarding hypothetical protocol
- Level of Satisfaction with consent process
- Expressed willingness to participate in the hypothetical protocol
|Study Start Date:||April 2006|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00453544
|Contact: Tia Thrasher, BAfirstname.lastname@example.org|
|Contact: Luz Pinto, BSemail@example.com|
|United States, California|
|Veterans Affairs San Diego Healthcare System||Recruiting|
|San Diego, California, United States, 92161|
|Principal Investigator:||Barton W. Palmer, PhD||UCSD|