Validation of Patient Reported Outcome Measures for Use in Hallux Valgus
Completed
- Conditions
- Hallux Valgus
- Registration Number
- NCT03846687
- Lead Sponsor
- Ipsen
- Brief Summary
The purpose of the study is to explore whether the mFFI is fit for purpose in adults with hallux valgus (HV).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
Inclusion Criteria
- Male or female, of any race and, aged ≥ 18 years
- Clinical diagnosis of hallux valgus
- Fluent in reading/speaking US-English to read and understand informed consent form and to participate in the interview
Exclusion Criteria
- Participation in another foot-based clinical trial in the last 90 days or in Ipsen's clinical trial D-FR-52120-237
- Current chronic drug or alcohol abuse problem
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cognitive debriefing (CD) of mFFI 7 days Face-to-face interview (approx. 25 minutes) to explore understanding and relevance of mFFI items.
Concept elicitation (CE) of mFFI 7 days Face-to-face interview (approx. 25 minutes), using semi-structured interview guide to explore the symptoms and impact of HV.
Usability testing of mFFI 7 days Telephone interview (approx. 20 minutes) using a semi-structured interview guide to explore how participants found usability of completing the mFFI daily in electronic format on their own device.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
University Foot and Ankle Institute
🇺🇸Santa Monica, California, United States
Ankle and Foot Care Centers
🇺🇸Youngstown, Ohio, United States
Futuro Clinical Trials, LLC
🇺🇸McAllen, Texas, United States
University Foot and Ankle Institute🇺🇸Santa Monica, California, United States