Trials / Completed
CompletedNCT00105612
Memory Aid for Informed Consent in Alzheimer's Research
Improving Informed Consent in Alzheimer's Disease Research
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 110 (planned)
- Sponsor
- National Institute on Aging (NIA) · NIH
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The purpose of this trial is to test whether a memory and organizational aid in the form of a document that summarizes and simplifies a study's key points can improve the decision-making abilities and competency of mild to early moderate Alzheimer's disease (AD) patients.
Detailed description
Studies of mild to moderate Alzheimer's disease (AD) patients reveal substantial variation in their ability to participate in an informed consent process. No published data show techniques that help an AD patient to participate in an informed consent. This research will address this issue by performing a randomized trial to test whether a memory and organizational aid can improve the decision-making abilities and competency of AD patients. This study will recruit 80 patients with mild to early moderate AD, and 30 non-demented elderly persons. The informed consent protocol for a hypothetical early-phase drug trial will be administered by a trained interviewer in the patient's home. The AD patients will be randomized to receive either the standard informed consent process or the intervention of the standard informed consent process plus the memory and organizational aid. All non-demented elderly individuals will receive the standard informed consent process. The interviewer will administer the protocol to participants and ask questions that will assess participant capacity to understand, appreciate, reason, and make a choice concerning enrollment in the hypothetical study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Memory and Organizational Aid | |
| BEHAVIORAL | Standard Informed Consent Process | The informed consent protocol for a hypothetical early-phase drug trial will be administered by a trained interviewer in the patient's home |
Timeline
- Start date
- 2004-09-01
- Primary completion
- 2007-03-01
- Completion
- 2007-03-01
- First posted
- 2005-03-16
- Last updated
- 2009-12-29
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00105612. Inclusion in this directory is not an endorsement.