Web-based Validation Pelvic Floor Questionnaires
Validation of Electronic (Web-based and Smartphone) Administration of Measures of Pelvic Floor Dysfunction
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
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Alberta
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Calgary, Alberta, Канада, T2N 1N4
- University Of Calgary
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Arkansas
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Fayetteville, Arkansas, Соединенные Штаты, 72701
- University of Arkansas
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New York
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New York, New York, Соединенные Штаты, 10032
- Columbia University Irving Medical Center
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Texas
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Houston, Texas, Соединенные Штаты, 77030
- Houston Methodist Hospital
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Wisconsin
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Madison, Wisconsin, Соединенные Штаты, 53726
- University of Wisconsin School of Medicine and Public Health
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
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.
Описание
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)
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: Кейс-кроссовер
- Временные перспективы: Перспективный
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
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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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Test-retest reliability of PFDI-20 in the electronic format
Временное ограничение: 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 PFDI-20 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
|
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Test-retest reliability of PFIQ-7 in the electronic format
Временное ограничение: 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 PFIQ-7 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 PISQ-12 in the electronic format
Временное ограничение: 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 PISQ-12 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
|
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Test-retest reliability of BSS in the electronic format
Временное ограничение: 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 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
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Cara Grimes, MD, Columbia University
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- AAAO8451
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .