Web-based Validation Pelvic Floor Questionnaires

NCT02724891 | Completed

• 1 other identifier: AAAO8451
• Study Type: observational
• Target: 90
• Locations: 2 countries
• Sites: 5

Brief 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.

Conditions

Pelvic Floor Dysfunction

Keywords

Pelvic Floor Dysfunction

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Arm 1 paper form first

paper questionnaires first then web/smart phone questionnaires after a 2-week washout period

Other: paper form; Other: web/smartphone form

Arm 2 web/smartphone form first

web/smart phone questionnaires first then paper questionnaires after a 2-week washout period

Other: paper form; Other: web/smartphone form

Interventions

paper form OTHER

questionnaires in paper form

Arm 1 paper form first; Arm 2 web/smartphone form first

web/smartphone form OTHER

questionnaires in web/smartphone

Arm 1 paper form first; Arm 2 web/smartphone form first

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Women at least 18 years of age presenting with pelvic floor dysfunction

You may not qualify if:

• 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)

Sponsors & Collaborators

• Columbia University: lead
• University of Wisconsin, Madison: collaborator
• University of Arkansas: collaborator
• The Methodist Hospital Research Institute: collaborator
• University of Calgary: collaborator

Study Sites (5)

University of Arkansas

Fayetteville, Arkansas, 72701, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53726, United States

Location

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

Related Publications (1)

• Grimes CL, Antosh DD, Oliphant S, Yurteri-Kaplan L, Kim-Fine S, Melamud G, Heisler C, Chung DE; Collaborative Research in Pelvic Surgery Consortium (CoRPS). Correlation of Electronic (Web-Based and Smartphone) Administration of Measures of Pelvic Floor Dysfunction: A Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2020 Jun;26(6):396-400. doi: 10.1097/SPV.0000000000000713.

  PMID: 30889034 DERIVED

Study Officials

• Cara Grimes, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: March 31, 2016
• Study Start: February 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: April 1, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (4)