Web-based Validation Pelvic Floor Questionnaires
Validation of Electronic (Web-based and Smartphone) Administration of Measures of Pelvic Floor Dysfunction
調査の概要
詳細な説明
Health questionnaires and health diaries are two forms of patient-reported outcomes (PRO) commonly used in healthcare. Health questionnaires are often used as intake logs, discerning and recording the symptoms and severity of a problem at the time of presentation. Health diaries, in contrast, are ongoing logs which allow for mindful attention to symptoms and monitoring of response to therapy. Unfortunately, both types of PRO forms are often under-utilized or uninterpretable because they are collected on paper. Within urogynecology, PRO scales such as the Pelvic Floor Distress Inventory (PFDI), Pelvic Floor Impact Questionnaire (PFIQ), Bristol Stool Chart, Bladder Diaries and others are used ubiquitously. Their impact, however, is diminished by poor compliance and recall bias. The move towards electronic PRO measures would be endorsed by patients (who can track and interact with their data), physicians (who can track progress and study group outcomes) and by regulators (who want to ensure accurate and reproducible data collection). Electronic PRO tools, particularly on the patient's own device, would allow for increased rate of reporting through mobile availability, time stamping of data to prevent recall bias and reduction in data entry mistakes and costs.
Study Procedures After informed consent is obtained, demographic data will be collected. Subjects will be administered the questionnaires either in paper or web-based or smartphone form based on a random number block scheme. At least two weeks later but prior to treatment they will complete the other form of the questionnaire. This can occur at their next office visit or can be completed at home. Subjects will be emailed and/or called by research staff to remind them to complete the second set of questionnaires.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
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Arkansas
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Fayetteville、Arkansas、アメリカ、72701
- University of Arkansas
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New York
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New York、New York、アメリカ、10032
- Columbia University Irving Medical Center
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Texas
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Houston、Texas、アメリカ、77030
- Houston Methodist Hospital
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Wisconsin
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Madison、Wisconsin、アメリカ、53726
- University of Wisconsin School of Medicine and Public Health
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-
-
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Alberta
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Calgary、Alberta、カナダ、T2N 1N4
- University Of Calgary
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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
サンプリング方法
調査対象母集団
This is a prospective validation study. Subjects will be recruited at their visit to the Female Pelvic Medicine and Reconstructive Surgery offices and clinics at Columbia and Cornell. Demographic information will be collected at the initial visit/enrollment including age, race, parity, and presenting complaint.
Questionnaires will be administered based on a randomization scheme. These include:
- Pelvic Floor Disorders Inventory short form (PFDI-20)
- Pelvic Floor Impact Questionnaire (PFIQ-7)
- Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)
- Bristol Stool Scale (BSS)
Questionnaires will be administered via paper-based form, web-based, or smartphone app based on randomization scheme.
説明
Inclusion Criteria:
- Women at least 18 years of age presenting with pelvic floor dysfunction
Exclusion Criteria:
- Unable to repeat questionnaires or return to the office in 2 weeks
- No access to computer/web or smartphone
- Pregnancy (as gestational age will advance during 2 week time interval and symptoms may change)
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
- 観測モデル：ケースクロスオーバー
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Arm 1 paper form first
paper questionnaires first then web/smart phone questionnaires after a 2-week washout period
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questionnaires in paper form
questionnaires in web/smartphone
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Arm 2 web/smartphone form first
web/smart phone questionnaires first then paper questionnaires after a 2-week washout period
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questionnaires in paper form
questionnaires in web/smartphone
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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 |
|---|---|---|
|
Test-retest reliability of PFDI-20 in the electronic format
時間枠：minimum 2 week interval until subject receives treatment for the condition or up to one year
|
Subjects will complete the paper and either web-based or smartphone versions of the PFDI-20 with at least a 2 week interval between administration of the 2 versions.
|
minimum 2 week interval until subject receives treatment for the condition or up to one year
|
|
Test-retest reliability of PFIQ-7 in the electronic format
時間枠：minimum 2 week interval until subject receives treatment for the condition or up to one year
|
Subjects will complete the paper and either web-based or smartphone versions of the PFIQ-7 with at least a 2 week interval between administration of the 2 versions.
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minimum 2 week interval until subject receives treatment for the condition or up to one year
|
|
Test-retest reliability of PISQ-12 in the electronic format
時間枠：minimum 2 week interval until subject receives treatment for the condition or up to one year
|
Subjects will complete the paper and either web-based or smartphone versions of the PISQ-12 with at least a 2 week interval between administration of the 2 versions.
|
minimum 2 week interval until subject receives treatment for the condition or up to one year
|
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Test-retest reliability of BSS in the electronic format
時間枠：minimum 2 week interval until subject receives treatment for the condition or up to one year
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Subjects will complete the paper and either web-based or smartphone versions of the BSS with at least a 2 week interval between administration of the 2 versions.
|
minimum 2 week interval until subject receives treatment for the condition or up to one year
|
協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Cara Grimes, MD、Columbia University
出版物と役立つリンク
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 (実際)
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
キーワード
その他の研究ID番号
- AAAO8451
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?
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。