Validation of Patient Reported Outcome Measures for Use in Hallux Valgus

Validation of the Modified Foot Function Index (mFFI) for Use in Hallux Valgus

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03846687

Enrollment

Registered

2019-02-20

Start date

2018-10-30

Completion date

2020-01-15

Last updated

2020-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hallux Valgus

Brief summary

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.
Cognitive debriefing (CD) of mFFI	7 days	Face-to-face interview (approx. 25 minutes) to explore understanding and relevance of mFFI items.
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.

Countries

United States

Outcome results