Memory Aid for Informed Consent in Alzheimer's Research
Improving Informed Consent in Alzheimer's Disease Research
調査の概要
状態
詳細な説明
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.
研究の種類
入学
段階
- 適用できない
連絡先と場所
研究場所
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- University of Pennsylvania, Memory Disorders Clinic
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Live within one hour drive of the University of Pennsylvania's Memory Disorders Clinic
- Education equivalent to 6th grade level
- Corrected visual acuity of at least 20/70
- Speak English
- Diagnosed with possible or probable AD, or non-demented
- MMSE (Mini Mental State Exam) >= 18
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 割り当て：ランダム化
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
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MacArthur Competency Assessment Tool for Clinical Research (MacCAT-CR) to quantify decision making abilities
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二次結果の測定
結果測定 |
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Participant competency
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協力者と研究者
捜査官
- 主任研究者：Jason Karlawish, MD、University of Pennsylvania Institute on Aging
出版物と役立つリンク
一般刊行物
- Marson DC, Ingram KK, Cody HA, Harrell LE. Assessing the competency of patients with Alzheimer's disease under different legal standards. A prototype instrument. Arch Neurol. 1995 Oct;52(10):949-54. doi: 10.1001/archneur.1995.00540340029010.
- Kim SY, Caine ED, Currier GW, Leibovici A, Ryan JM. Assessing the competence of persons with Alzheimer's disease in providing informed consent for participation in research. Am J Psychiatry. 2001 May;158(5):712-7. doi: 10.1176/appi.ajp.158.5.712.
- Sachs GA, Stocking CB, Stern R, Cox DM, Hougham G, Sachs RS. Ethical aspects of dementia research: informed consent and proxy consent. Clin Res. 1994 Oct;42(3):403-12. No abstract available.
- Karlawish JH, Casarett DJ, James BD. Alzheimer's disease patients' and caregivers' capacity, competency, and reasons to enroll in an early-phase Alzheimer's disease clinical trial. J Am Geriatr Soc. 2002 Dec;50(12):2019-24. doi: 10.1046/j.1532-5415.2002.50615.x.
- Appelbaum PS, Grisso T. The MacArthur Competence Assessment Tool - Clinical Research. Sarasota, FL: Professional Resources Press, 2000.
- Rubright J, Sankar P, Casarett DJ, Gur R, Xie SX, Karlawish J. A memory and organizational aid improves Alzheimer disease research consent capacity: results of a randomized, controlled trial. Am J Geriatr Psychiatry. 2010 Dec;18(12):1124-32. doi: 10.1097/JGP.0b013e3181dd1c3b.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。