Desktop Versus Mobile Data Collection in Clinical Trial
Desktop vs. Mobile Data Collection in a Prospective Multicenter Clinical Trial
Paper-based data collection for prospective clinical trials is associated with a poor quality of data collection. This typically involves missing or wrong data entry or a low recruitment rate, mainly due to the cumbersome and uncontrolled data collection.
Electronic data collection is associated with improved quality of data entry in the cases of Electronic Patient Records (EPR) and patient handover among doctors during night and day shifts. However, a comprehensive direct comparison between web-based desktop personal computer (PC) and mobile (e.g. iPad) data collection has not yet been reported.
The purpose of this prospective trial is to compare the users' experience with the web-based desktop PC and mobile data collection (iPad) tools.
調査の概要
詳細な説明
The investigators designed a prospective randomized controlled trial where doctors from several randomly selected hospitals will use either a desktop PC or mobile (iPad) data collection tool. A validated user experience evaluation instrument will be used at the beginning, during interim analysis and at the end of the trial.
The desktop-based data collection is built on Drupal, a renowned open source content management system (CMS). The same CMS will be used with a special interface designed for iOS/iPad. Both data collection platforms will be used in parallel to a prospective clinical trial.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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St. Gallen、スイス、CH-9000
- University of St. Gallen, Institute of Information Managemen
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Zurich、スイス、CH-8091
- University Hospital Zurich, Department of Surgery
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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:
- Emergency Room doctors
- Surgeons
- Agree to participate in the trial
- Provide informed consent
- Have basic information technology literacy
- Agree to receive brief training of the platform
Exclusion Criteria:
- Clinicians and health care professionals not part of this trial
- Lacking of basic information technology literacy
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
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：単一グループの割り当て
- 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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アクティブコンパレータ：Desktop PC
Conventional institutional Desktop Personal Computers will be used to collect data of patients via a password protected encrypted interface.
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A validated user experience evaluation questionnaire will be completed by each participant in the beginning, at the interim period, and at the end of the trial
他の名前：
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実験的：Mobile
Novel Mobile Clinical Trial Management System on iPads will be used to collect data of patients via a password protected encrypted interface.
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A validated user experience evaluation questionnaire will be completed by each participant in the beginning, at the interim period, and at the end of the trial
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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Evaluation score
時間枠：2 years
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A validated user experience and evaluation instrument will be used. The overall score will be compared between the Desktop PC and Mobile (iPad) data collection tools. PC: indicates Personal Computer |
2 years
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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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Recruitment rate
時間枠：2 years
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The recruitment rate is defined as the proportion of patients recruited divided by the total number of patients recruited + patients missed: (rate=recruited/(recruited+missed). The recruitment rates will be compared between the Desktop PC and Mobile (iPad) data collection tools. PC: indicates Personal Computer |
2 years
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Cost-effectiveness analysis
時間枠：2 years
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Cost-effectiveness analysis (CEA) is a form of economic analysis that compares the relative costs and outcomes (effects) of two or more courses of action. CEA assigns a monetary value to the measure of effect. Typically the CEA is expressed in terms of a ratio where the denominator is a gain from a measure and the numerator is the cost associated with this gain. In this study, CEA will be calculated as: (ratio=costs/evaluation score) and (ratio=costs/recruitment rate). |
2 years
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Cost-benefit analysis
時間枠：2 years
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Cost-benefit analysis (CBA) is a systematic process for calculating and comparing benefits and costs of a project for two purposes; in order to determine if it is a sound investment (justification/feasibility), and to see how it compares with alternate projects (ranking/priority assignment).
It involves comparing the total expected cost of each option against the total expected benefits, to see whether the benefits outweigh the costs, and by how much.
In CBA, benefits and costs are expressed in money terms, and are adjusted for the "time value of money".
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2 years
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Cost-utility analysis
時間枠：2 years
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Cost-utility analysis (CUA) is a form of financial analysis used to guide procurement decisions.
The most common and well-known application of this analysis is in health technology assessment.
Cost is measured in monetary units.
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2 years
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Dimitri A Raptis, MD, MSc、University Hospital Zurich, Department of Surgery
- 主任研究者：Rolf Graf, PhD、University Hospital Zurich, Department of Surgical Research
出版物と役立つリンク
一般刊行物
- Raptis DA, Mettler T, Tzanas K, Graf R. A novel open-source web-based platform promoting collaboration of healthcare professionals and biostatisticians: a design science approach. Inform Health Soc Care. 2012 Jan;37(1):22-36. doi: 10.3109/17538157.2011.590257. Epub 2011 Oct 19.
- Raptis DA, Fernandes C, Chua W, Boulos PB. Electronic software significantly improves quality of handover in a London teaching hospital. Health Informatics J. 2009 Sep;15(3):191-8. doi: 10.1177/1460458209337431.
- Mirani R, Lederer A. An Instrument for Assessing the Organizational Benefits of IS projects. Decision Sciences, Vol. 29, No. 4, 1998, 803-838.
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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。
Evaluation formの臨床試験
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MedtronicNeuro完了
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Ohio State UniversityUniversity of Minnesota; Rutgers University完了
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Centre Hospitalier ArrasF2RSM Psy (Hauts-de-France Regional Federation for Research in Psychiatry and Mental Health)引きこもった
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Centre Hospitalier Metropole Savoie募集