Distracted Driving App Study for Teens and Parents/Caregivers (IDD)
2021年11月11日 更新者：Children's Hospital of Philadelphia
An Informatics Approach to Preventing Distracted Driving
The purpose of this research study is to determine if a new smartphone application helps to decrease distracted driving, and to learn about parent and teen perspectives about the application
調査の概要
詳細な説明
This 3-group randomized controlled trial aims to (1) evaluate the frequency of smartphone use among young drivers and their parents/caregivers while driving; and (2) determine if the LifeSaver mobile app reduces the rate of smartphone use while driving.
Eligible participants will be licensed teenage drivers between the ages of 16 and 18 years, and a parent/caregiver.
The app will be downloaded and installed on both parent/caregivers' and teens' phones to monitor phone use while in a vehicle for 8 weeks.
研究の種類
介入
入学 (実際)
134
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
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19146
- Children's Hospital of Philadelphia Roberts Center for Pediatric Research
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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
16年歳以上 (子、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:
- Licensed teen drivers 16 years to 18 years and one parent/caregiver
- Teen and parent/caregiver are both Android smartphone users
- Teen and parent/caregiver both drive a minimum of 2 days per week
Exclusion Criteria:
- Non-fluency in written or spoken English
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：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- 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 |
|---|---|
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実験的：Arm 1
Participants alternate between using the Manual Mode of the app for 2 weeks and Auto-Detect Mode of the app for 2 weeks, for a total of 4 periods (8 weeks).
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In addition to the features in the Background Mode, the LifeSaver app locks the participants' phone while they are in a moving vehicle unless they actively press an "Emergency Unlock" or "Passenger Unlock" button.
他の名前：
In addition to the features in Manual Mode, the LifeSaver app's "Passenger Unlock" feature can only be used if the app, via the smartphone's camera, confirms that the participant is not the driver of the vehicle.
他の名前：
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実験的：Arm 2
Participants use the Auto-Detect Mode of the app for 4 weeks, followed by the Manual Mode for 4 weeks.
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In addition to the features in the Background Mode, the LifeSaver app locks the participants' phone while they are in a moving vehicle unless they actively press an "Emergency Unlock" or "Passenger Unlock" button.
他の名前：
In addition to the features in Manual Mode, the LifeSaver app's "Passenger Unlock" feature can only be used if the app, via the smartphone's camera, confirms that the participant is not the driver of the vehicle.
他の名前：
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実験的：Arm 3
Participants use the Background Mode of the app for 4 weeks, followed by the Auto-Detect Mode of the app for 4 weeks.
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In addition to the features in Manual Mode, the LifeSaver app's "Passenger Unlock" feature can only be used if the app, via the smartphone's camera, confirms that the participant is not the driver of the vehicle.
他の名前：
The LifeSaver app tracks the date, time, and global positioning system (GPS) location of each trip that the participant takes in a moving vehicle, along with a list of apps used during the trip, but does not contain any anti-distracted driving features.
他の名前：
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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 |
|---|---|---|
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Change in frequency of smartphone use while driving
時間枠：Week 2, 4, 6, and post-intervention at Week 8
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Frequency of smartphone use is recorded by the LifeSaver app among the three app modes.
Within-driver smartphone use over the 8-week study period is compared as the app modes change.
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Week 2, 4, 6, and post-intervention at Week 8
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in frequency of self-reported smartphone use while driving
時間枠：Weeks 2, 4, 6, and Post-Intervention at Week 8
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The change in self-reported smartphone use while driving will be assessed using the same within-driver and between-driver comparisons as the primary outcome measure.
Self-reported smartphone use is collected through 10 items on a participant survey that is completed at enrollment, Weeks 2, 4, 6 and post-intervention at Week 8. Participants report how many days during the previous 2 weeks (0-14) that they drove, and talked on a hands-held smartphone, talked on a hands-free smartphone, sent a text, and read a text while driving.
Participants also report how many times per day (free text, any number greater than or equal to 0) that they drove, and talked on a hands-held smartphone, talked on a hands-free smartphone, sent a text, and read a text while driving.
There is no overall self-reported smartphone use score for these survey items.
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Weeks 2, 4, 6, and Post-Intervention at Week 8
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Participant acceptability of the smartphone App: survey
時間枠：Post-Intervention at Week 8
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Participant assessment of accessibility will be collected, and Manual Mode and Auto-Detect Mode of the LifeSaver app will be compared.
Participants complete a survey at Week 8, post-intervention.
8 items in the survey ask participants about accessibility of the app through Likert scales (range from Not at all to Extremely). 3 items in the survey ask participants about accessibility of the app through open-ended questions, where participants are able to enter free text.
There is no overall score for these survey items.
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Post-Intervention at Week 8
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Participant usability of the smartphone app: survey
時間枠：Post-Intervention at Week 8
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Participant assessment of usability will be collected, and Manual Mode and Auto-Detect Mode of the LifeSaver app will be compared.
Participants complete a survey at Week 8, post-intervention.
8 items in the survey ask participants about usability of the app through Likert scales (range from Not at all to Extremely). 3 items in the survey ask participants about usability of the app through open-ended questions, where participants are able to enter free text.
There is no overall score for these survey items.
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Post-Intervention at Week 8
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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。
捜査官
- 主任研究者：Sara Seifert, MPH、Minnesota HealthSolutions
- 主任研究者：Allison Curry, PhD, MPH、Children's Hospital of Philadelphia
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)
2020年1月23日
一次修了 (実際)
2021年8月31日
研究の完了 (実際)
2021年8月31日
試験登録日
最初に提出
2019年11月22日
QC基準を満たした最初の提出物
2019年11月25日
最初の投稿 (実際)
2019年11月26日
学習記録の更新
投稿された最後の更新 (実際)
2021年11月19日
QC基準を満たした最後の更新が送信されました
2021年11月11日
最終確認日
2021年11月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 19-016717
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?
はい
IPD プランの説明
Data and study documents will be shared with Minnesota HealthSolutions (the sponsor).
No identifiable data will be used for future studies without first obtaining CHOP Institutional Review Board (IRB) approval.
The investigator will obtain a data use agreement between the provider (the PI) of the data and any recipient researchers (including others at CHOP) before sharing a limited dataset (PHI limited to dates and zip codes).
IPD 共有時間枠
The study will comply with CHOP's data retention policy.
All study data will be maintained for at least 6 years following study completion.
There is no set timeline for the destruction of the study's de-identified data.
IPD 共有アクセス基準
IRB approval, data use agreement
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
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。