A Patient Reported Outcome Measure for Vulval Conditions
Development and Psychometric Analysis of a Patient Reported Outcome Measure for Patients Attending a Specialist Vulval Clinic
1 other identifier
observational
165
0 countries
N/A
Brief Summary
To create a new patient reported outcome measure in the form of a questionnaire, which will accurately reflect the profound impact that vulval dermatoses and vulval pain syndromes have on patients' quality of life
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2021
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2021
CompletedFirst Posted
Study publicly available on registry
October 4, 2021
CompletedStudy Start
First participant enrolled
October 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2022
CompletedOctober 4, 2021
October 1, 2020
4 months
September 23, 2021
September 23, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
questionnaire development
questionnaire development
1 year
Study Arms (2)
focus group
15 service users for focus group
questionnaire
150 patients to test questionnaire
Interventions
Eligibility Criteria
vulval dermatoses and vulval pain syndromes patients
You may qualify if:
- \) Adult female patients aged 18 upwards 2) Patients must have a vulval dermatosis or vulval pain syndrome confirmed on history and examination. These will include inflammatory dermatoses, non-inflammatory dermatoses and vulval pain syndromes
You may not qualify if:
- \) Patient with a vulval condition thought to be of a sexually transmitted aetiology 2) Patients lacking capacity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2021
First Posted
October 4, 2021
Study Start
October 9, 2021
Primary Completion
February 1, 2022
Study Completion
April 15, 2022
Last Updated
October 4, 2021
Record last verified: 2020-10