Comparison of an Electronic Version of Selected COPD PRO Instruments With the Original Versions

nSpire Health

Status: Completed

Conditions: COPD

Study type: Observational

Funder types: Industry

Identifiers

NCT01875302

NSH-001

Details and patient eligibility

About

This protocol defines the requirements to demonstrate that the PRO instruments which were designed as paper-based are equivalent to the nSpire Health ePRO (electronic patient reported outcome), following the ISPOR's ePRO Good Research Practices Task Force recommendations. All validation studies of the questionnaires were conducted using the original paper versions.

Enrollment: 20 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Give their signed written informed consent to participate
• Current symptoms COPD, as diagnosed by a physician
• Age 40 - 75 years
• Able to read and understand English

Exclusion criteria

• Unwilling to complete the 3 electronic PRO questionnaires or participate in an interview during completion of questionnaires