Informed Consent Formats by Information Preference and Priority
2018年1月24日 更新者：Carnegie Mellon University
This study will test whether different formats of medical informed consent documents can help improve understanding and confidence in decision-making for clinical trials.
The study will be primarily run through an online survey.
調査の概要
状態
完了
詳細な説明
The goal of this study is to investigate whether the same information can be communicated in different formats of an informed consent document in ways that improve participant understanding and confidence.
Participants will review one of several different versions of the same informed consent document, and will be asked to complete a survey after reading the documents.
The survey will ask participants their willingness to enroll in the clinical trial discussed in the document and their confidence in their decision.
The survey will also test participants recollection of information from the informed consent document.
Researchers will look at this data to see if there are ways to improve knowledge about the clinical trial and confidence in decisions without necessarily changing enrollment preferences.
研究の種類
介入
入学 (実際)
500
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Pennsylvania
-
Pittsburgh、Pennsylvania、アメリカ、15213
- Carnegie Mellon University
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- 18 Years Old or Older
- Read and agreed to informed consent
- Indicated desire to participate
- Diagnosed with asthma
- US resident
Exclusion Criteria:
- Participants from whom we receive multiple responses will be dropped from analysis (but will be compensated for participation)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Original
Participants will review the full-length, original consent form for the clinical trial.
|
Participants will review the full-length, original consent form for the clinical trial.
|
|
実験的：Shortened
Participants will review a shortened consent form for the clinical trial, which includes only material indicated as important by 2/3 of participants from a previous study.
|
Participants will review a shortened consent form for the clinical trial, which includes only material indicated as important by 2/3 of participants from a previous study.
|
|
実験的：Reordered
Participants will review a reordered, shortened consent form.
This form is based on the shortened consent form, but the sections are reordered based on a previous study, such that sentences previously rated as more likely to impact a participant's decision is more likely to be presented first (except for an initial introductory section).
|
Participants will review a reordered, shortened consent form.
This form is based on the shortened consent form, but the sections are reordered based on a previous study, such that sentences previously rated as more likely to impact a participant's decision is more likely to be presented first (except for an initial introductory section).
|
|
実験的：Highlighted
Participants will review a shortened consent form with a highlights box, where the highlights box includes the 10 sentences rates as most likely to impact a participant's decision from a previous study.
|
Participants will review a shortened consent form with a highlights box, where the highlights box includes the 10 sentences rates as most likely to impact a participant's decision from a previous study.
|
|
実験的：Interactive
Participants will review an interactive, shortened consent form, where hyperlinks to different sections of the consent form are provided.
The landing page includes the introductory section.
|
Participants will review an interactive, shortened consent form, where hyperlinks to different sections of the consent form are provided.
The landing page includes the introductory section.
|
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Score for high impact questions
時間枠：through study completion, an average of 30 minutes
|
Sum of correct answers (T/F) for any item relating to material that was rated as 50 or higher on impact on willingness to enroll in a previous study.
|
through study completion, an average of 30 minutes
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Score for low impact questions
時間枠：through study completion, an average of 30 minutes
|
Sum of correct answers (T/F) for any item relating to material that was rated as 49 or lower on impact on willingness to enroll in a previous study.
|
through study completion, an average of 30 minutes
|
|
Total score for all questions
時間枠：through study completion, an average of 30 minutes
|
Sum of correct answers (T/F) on full knowledge test.
|
through study completion, an average of 30 minutes
|
|
Interaction effect of format and importance on likelihood of correct answer
時間枠：through study completion, an average of 30 minutes
|
Interaction effect in a logistic regression predicting a correct answer, based on the format of the consent form and the importance of the answer.
|
through study completion, an average of 30 minutes
|
|
Scores for different information categories
時間枠：through study completion, an average of 30 minutes
|
Sum of correct answers (T/F) for each of the 20 information categories
|
through study completion, an average of 30 minutes
|
|
Effect of location on score
時間枠：through study completion, an average of 30 minutes
|
Logistic regression coefficient of likelihood of predicting a correct answer, based upon the location on which the sentence appeared--uses only the shortened, and the reordered conditions.
Note that sentences appearing in the introduction (which is the first section of all treatments) must be dropped, as there will be no variation in location.
|
through study completion, an average of 30 minutes
|
|
Decision to enroll
時間枠：through study completion, an average of 30 minutes
|
Likert measure of participants hypothetical decision to enroll in the study
|
through study completion, an average of 30 minutes
|
|
Confidence in enrollment decision
時間枠：through study completion, an average of 30 minutes
|
Likert measure of participants confidence in hypothetical decision to enroll in the study
|
through study completion, an average of 30 minutes
|
|
Satisfaction with consent structure
時間枠：through study completion, an average of 30 minutes
|
Likert measure of participants satisfaction with the consent form
|
through study completion, an average of 30 minutes
|
|
Perception of investigator concern for well being
時間枠：through study completion, an average of 30 minutes
|
Likert measure of participants belief in the investigator's concerns for the participant's well-being
|
through study completion, an average of 30 minutes
|
|
Perception of investigator transparency
時間枠：through study completion, an average of 30 minutes
|
Likert measure of participants belief that the investigator is trying to communicate information about the trial accurately
|
through study completion, an average of 30 minutes
|
|
Participant's probability estimate of the likelihood that the treatment would help control their asthma
時間枠：through study completion, an average of 30 minutes
|
Survey question of the following form: 'If you enrolled in the trial described in the consent form, what is the probability that the treatment could help control your asthma better, where 0% means "no chance at all of helping" and 100% means "would definitely help"?' Participants provided with drop-down menu including values from 0% to 100% in increments of 1%. |
through study completion, an average of 30 minutes
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Participant's free-response text describing what was learned from reading the informed consent document
時間枠：through study completion, an average of 30 minutes
|
Survey question of the following form: "What are some of the key things you learned from reading the informed consent document?" Participants are then provided with an free-response text box where they are allowed to enter whatever text they want, as long as they enter some text. These responses will be coded by two independent coders, blinded to the treatment arms, using an emergent coding system to identify different topics that participants may raise. |
through study completion, an average of 30 minutes
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
協力者
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年11月27日
一次修了 (実際)
2017年12月31日
研究の完了 (実際)
2017年12月31日
試験登録日
最初に提出
2018年1月8日
QC基準を満たした最初の提出物
2018年1月24日
最初の投稿 (実際)
2018年1月31日
学習記録の更新
投稿された最後の更新 (実際)
2018年1月31日
QC基準を満たした最後の更新が送信されました
2018年1月24日
最終確認日
2018年1月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- STUDY2017_00000268
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
IPD プランの説明
Intend to share deidentified participant data, but we want to review the received data to ensure that there is no information that could potentially reveal individual identity that we may not initially anticipate.
As such, a clear delineation of what data will be disclosed is not yet available.
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
いいえ
米国FDA規制機器製品の研究
いいえ
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。
Original consent formの臨床試験
-
Bio-Strath AGZentrum für Adipositas- und Stoffwechselmedizin Winterthur GmbH完了
-
Ohio State UniversityUniversity of Minnesota; Rutgers University完了
-
Purdue Universityまだ募集していません
-
Centre Hospitalier ArrasF2RSM Psy (Hauts-de-France Regional Federation for Research in Psychiatry and Mental Health)引きこもった