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

nSpire Health, Inc.20 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

COPD

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Demonstrate that the following PRO instruments which were designed as paper-based are equivalent to the nSpire Health ePRO (electronic patient reported outcome)

The primary measures to demonstrate equivalency of electronic to paper PRO instruments are Usability and Cognitive Debriefing. Usability data is gathered using systematic observation under controlled conditions to determine how well the device may be used by subjects. Qualitative, Content Analysis of Cognitive Debriefing Data The cognitive debriefing data will be content analyzed for subject understanding of the instructions on the device used to deliver the PRO instrument.

Time frame: 60 minutes

Data from ClinicalTrials.gov

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