Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02724891
Other study ID # AAAO8451
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06037226 - A National Observation Study on Pelvic Floor Dysfunction Diseases in China
Completed NCT03199534 - A Trial of Pelvic Floor Chemodenervation in Patients Undergoing Physical Therapy for High Tone Pelvic Floor Dysfunction Phase 4
Completed NCT03979755 - Pelvic Floor Dysfunction in Cancer Survivors.
Not yet recruiting NCT05252455 - A RCT to Evaluate the Effects of Pelvic and Abdominal Mechanical Exercises During Pregnancy on Reducing the Rate of CS and Preventing PFD N/A
Recruiting NCT03511911 - The Evaluation of Pelvic Floor Muscle Function: A Reliability and Correlation Study N/A
Completed NCT01753258 - Outcomes of Delivery in Patients With Dyspareunia N/A
Completed NCT00580879 - Does Antenatal Fetal Head Circumference Predict Anal Sphincter Injury, a Prospective Study N/A
Completed NCT05251220 - Efficacy and Safety of the Neodymium Laser in Treatment of Urogenital Tract Diseases in Women
Completed NCT02782377 - Evaluation of the Rectal Reflex Using Anal Acoustic Reflectometry
Completed NCT04036578 - Efficacy of Biofeedback in Women With Pelvic Floor Dysfunction N/A
Completed NCT02391285 - Mitigating Chronic Pelvic Floor Dysfunction Following Childbirth by Pelvic Floor Dynamometry N/A
Active, not recruiting NCT05595967 - Community Based Health Education for Prevention of Pelvic Floor Dysfunction in Fertile Women in Rural China N/A
Active, not recruiting NCT05955664 - Evaluation of Diffusion Tensor Imaging and High Frequency 3D Endovaginal Ultrasound N/A