Validation of Patient Reported Outcome Measures for Use in Hallux Valgus

N/ACompletedNCT03846687

Ipsen21 enrolled

Overview

The purpose of the study is to explore whether the mFFI is fit for purpose in adults with hallux valgus (HV).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hallux Valgus

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Concept elicitation (CE) of mFFI

Face-to-face interview (approx. 25 minutes), using semi-structured interview guide to explore the symptoms and impact of HV.

Time frame: 7 days

Cognitive debriefing (CD) of mFFI

Face-to-face interview (approx. 25 minutes) to explore understanding and relevance of mFFI items.

Time frame: 7 days

Usability testing of mFFI

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.

Time frame: 7 days

Data from ClinicalTrials.gov

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