Enhancing Consent for Alzheimer's Research
| Status: | Completed |
|---|---|
| Conditions: | Alzheimer Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 4/2/2016 |
| Start Date: | April 2006 |
| End Date: | December 2011 |
| Contact: | Tia Thrasher, BA |
| Email: | tthrasher@ucsd.edu |
| Phone: | 858-535-5795 |
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.
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.
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.
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.
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
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