- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02724891
Web-based Validation Pelvic Floor Questionnaires
Validation of Electronic (Web-based and Smartphone) Administration of Measures of Pelvic Floor Dysfunction
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
Alberta
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Calgary, Alberta, Canada, T2N 1N4
- University of Calgary
-
-
-
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Arkansas
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Fayetteville, Arkansas, Stati Uniti, 72701
- University of Arkansas
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New York
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New York, New York, Stati Uniti, 10032
- Columbia University Irving Medical Center
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Texas
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Houston, Texas, Stati Uniti, 77030
- Houston Methodist Hospital
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Wisconsin
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Madison, Wisconsin, Stati Uniti, 53726
- University of Wisconsin School of Medicine and Public Health
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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.
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Caso-Crossover
- Prospettive temporali: Prospettiva
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
---|---|
Arm 1 paper form first
paper questionnaires first then web/smart phone questionnaires after a 2-week washout period
|
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
|
questionnaires in paper form
questionnaires in web/smartphone
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Test-retest reliability of PFDI-20 in the electronic format
Lasso di tempo: 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.
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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
Lasso di tempo: 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.
|
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
Lasso di tempo: 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
|
Test-retest reliability of BSS in the electronic format
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Cara Grimes, MD, Columbia University
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- AAAO8451
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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