Qualitative Validation of Patient-Reported Outcomes (PRO) Instrument

AcuFocus

Status: Completed

Conditions: Patient-Reported Outcomes (PRO)

Study type: Observational

Funder types: Industry

Identifiers

NCT03536715

KAMR-201-PRO1

Details and patient eligibility

About

The purpose of this study is to conduct concept elicitation and cognitive debriefing interviews with patients who have been implanted with the KAMRA inlay in order to assess the content validity of a PRO instrument

Enrollment: 22 patients

Sex: All

Ages: 45 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Minimum 45 years of age, maximum age 60 years;
2. Subject has been implanted with the KAMRA inlay;
3. Subject is in good general health, as evidenced by medical history;
4. Subject is willing and able to attend and participate in the interviews and demographic questionnaire (fluent in U.S. English); and
5. Signed informed consent document.

Exclusion criteria

1. Subject has severe neurological or cognitive deficits or an uncontrolled psychiatric condition that might affect their ability to participate in the interview;
2. Subject has insufficient ability to read or write that would prevent them from completing a questionnaire without help;
3. Subject is not a fluent speaker of U.S. English; or
4. Subject is unable to attend the interview.