Pelvic Floor DysfunctionNCT02724891
Web-based Validation Pelvic Floor Questionnaires
An observational study of Pelvic Floor Dysfunction, run by Columbia University at 5 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Floor Dysfunction
- What is being tested?
- paper form and web/smartphone form
- How many people
- 90 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Feb 2015to Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Women at least 18 years of age presenting with pelvic floor dysfunction
Who cannot join
- 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)
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
University of Arkansas
Fayetteville, Arkansas, 72701
Houston Methodist Hospital
Houston, Texas, 77030
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53726
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Validation of Electronic (Web-based and Smartphone) Administration of Measures of Pelvic Floor Dysfunction
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.
Read the detailed 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.
- Conditions
- Pelvic Floor Dysfunction
- Being tested
- paper form, web/smartphone form
- Keywords
- Pelvic Floor Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paper formOther
questionnaires in paper form
web/smartphone formOther
questionnaires in web/smartphone
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 paper form first | paper questionnaires first then web/smart phone questionnaires after a 2-week washout period Receives: 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 Receives: Other: paper form; Other: web/smartphone form |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: minimum 2 week interval until subject receives treatment for the condition or up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startFeb 2015
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor DysfunctionStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wisconsin, Madison, University of Arkansas, The Methodist Hospital Research Institute, University of Calgary
- Responsible party
- Sponsor
- Investigators
- Cara Grimes, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724891
- Sponsor's protocol ID
- AAAO8451
- Status last verified
- Mar 2019
- First submitted
- 4 Feb 2016
- Last updated
- 1 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 30889034
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Electronic (Web-based and Smartphone) Administration of Measures of Pelvic Floor Dysfunction
- ClinicalTrials.gov ID
- NCT02724891
- Acronym / sponsor ID
- AAAO8451
- Conditions
- Pelvic Floor Dysfunction
- Keywords
- Pelvic Floor Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- University of Wisconsin, Madison, University of Arkansas, The Methodist Hospital Research Institute, University of Calgary
- Study start
- Feb 2015
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 31 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 paper form first | – | Other: paper form, Other: web/smartphone formpaper questionnaires first then web/smart phone questionnaires after a 2-week washout period |
| Arm 2 web/smartphone form first | – | Other: paper form, Other: web/smartphone formweb/smart phone questionnaires first then paper questionnaires after a 2-week washout period |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Women at least 18 years of age presenting with pelvic floor dysfunction
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paper formquestionnaires in paper form | Other | Arm 1 paper form first, Arm 2 web/smartphone form first |
| web/smartphone formquestionnaires in web/smartphone | Other | Arm 1 paper form first, Arm 2 web/smartphone form first |
Primary outcome
Test-retest reliability of PFDI-20 in the electronic format
Time frame: 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.
Test-retest reliability of PFIQ-7 in the electronic format
Time frame: 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.
Test-retest reliability of PISQ-12 in the electronic format
Time frame: 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.
Test-retest reliability of BSS in the electronic format
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2019.
- Derived from this study: PubMed 30889034Grimes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cara Grimes, MD principal investigator
Columbia University
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Floor Dysfunction, run by Columbia University at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test-retest reliability of PFDI-20 in the electronic format (time frame: minimum 2 week interval until subject receives treatment for the condition or up to one year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02724891, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2019.