Comparison of Video Consent Versus Routine Consent for Participation in Research Studies
Comparison of Video Consent and Routine Consent for Research
調査の概要
詳細な説明
This study will test a new method of delivering informed consent procedures to people with schizophrenia. The study has two aims. First, it will examine the impact of a multimedia DVD-based informed consent process on the ability of participants to make decisions regarding participation in research, both after the initial presentation of information and after 1 month. Second, it will examine the association between participant personal characteristics and the benefit derived from the DVD-based informed consent process.
Participants with schizophrenia and a normal comparison group will participate in either a routinely used informed consent procedure or an enhanced, DVD-based informed consent procedure. The outcome measure, comprehension of the consent materials, including understanding of the risks and benefits of participating in the study, will be assessed in each group. It is expected that the normal control group will reach the requisite level of comprehension faster than the schizophrenia group.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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California
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San Diego、California、アメリカ、92161
- University of California, San Diego
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-
参加基準
適格基準
就学可能な年齢
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:
- DSM-IV diagnosis of schizophrenia or no current or past major neuropsychiatric disorder (normal subjects)
- Fluency in English
- Written informed consent
Exclusion Criteria:
- Known or suspected dementia
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
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：DVD patient high risk
Patients with a diagnosis of schizophrenia/schizoaffective disorder randomized to the DVD, high risk version
|
Participants are randomized to DVD enhanced consent that is either high risk or low risk.
|
|
実験的：DVD patient low risk
Patient with a diagnosis of schizophrenia/schizoaffective disorder randomized to DVD consent, low risk version
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Participants are randomized to DVD enhanced consent that is either high risk or low risk.
|
|
実験的：DVD normal high risk
Participants with no psychiatric diagnosis randomized to DVD consent, high risk version
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Participants are randomized to DVD enhanced consent that is either high risk or low risk.
|
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実験的：DVD normal low risk
Participants with no psychiatric diagnosis randomized to DVD consent, low risk version
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Participants are randomized to DVD enhanced consent that is either high risk or low risk.
|
|
実験的：Routine control high risk
Participants with no psychiatric diagnosis randomized to routine consent, high risk version
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Participants are assigned to the routine, standard consent.
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実験的：Routine control low risk
Participants with no psychiatric diagnosis randomized to routine consent, low risk version
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Participants are assigned to the routine, standard consent.
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実験的：Routine patient low risk
Participants with schizophrenia/schizoaffective disorder randomized to routine consent, low risk version
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Participants are assigned to the routine, standard consent.
|
|
実験的：Routine patient high risk
Participants with schizophrenia/schizoaffective disorder randomized to routine consent, high risk version
|
Participants are randomized to DVD enhanced consent that is either high risk or low risk.
Participants are assigned to the routine, standard consent.
|
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 |
時間枠 |
|---|---|
|
Comprehension of the consent materials, including understanding of the risks and benefits of participating in the study
時間枠：Measured at 1-month follow-up
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Measured at 1-month follow-up
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Association of subject characteristics with the degree of benefit derived from the DVD-based consent over routine consent procedure
時間枠：Measured at 1-month follow-up
|
Measured at 1-month follow-up
|
協力者と研究者
捜査官
- 主任研究者：Dilip V. Jeste, MD、UCSD
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- R01MH067902 (米国 NIH グラント/契約)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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。
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