Web-based Validation Pelvic Floor Questionnaires

Pelvic Floor Dysfunction Clinical Trial

Official title:

Validation of Electronic (Web-based and Smartphone) Administration of Measures of Pelvic Floor Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02724891
• Other study ID #: AAAO8451
• Status: Completed
• Start date: February 2015
• Est. completion date: October 2018

Study information

• Verified date: March 2019
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patient-reported outcomes are commonly used in healthcare. Examples include validated symptom-based questionnaires and health diaries. In the field of Female Pelvic Medicine and Reconstructive Surgery there are many questionnaires and diaries that have been validated for a paper-based administration. As technology is incorporated into delivery of medical care and research, investigators need to consider how to collect data electronically while ensuring that this new format is equivalent to the paper questionnaires they rely on. In this study, the investigators aim to validate a series of validated questionnaires and symptom diaries administered via the web and smartphone for a more streamlined care for the patients.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pelvic Floor Dysfunction

Intervention

Other:
• paper form
questionnaires in paper form
• web/smartphone form
questionnaires in web/smartphone

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
United States	University of Arkansas	Fayetteville	Arkansas
United States	Houston Methodist Hospital	Houston	Texas
United States	University of Wisconsin School of Medicine and Public Health	Madison	Wisconsin
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (5)

Lead Sponsor	Collaborator
Columbia University	The Methodist Hospital System, University of Arkansas, University of Calgary, University of Wisconsin, Madison

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test-retest reliability of PFDI-20 in the electronic format	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
Primary	Test-retest reliability of PFIQ-7 in the electronic format	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
Primary	Test-retest reliability of PISQ-12 in the electronic format	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
Primary	Test-retest reliability of BSS in the electronic format	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