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

Completed

• Conditions: COPD

• Registration Number: NCT01875302
• Lead Sponsor: nSpire Health, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2013-04
• Study First Submitted: 2013-04-22
• Study Completion: 2013-05
• Status Verified: 2013-06
• Study First Submitted QC: 2013-06-07
• Study First Posted: 2013-06-11
• Last Update Submitted: 2013-06-17
• Last Update Posted: 2013-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Demonstrate that the following PRO instruments which were designed as paper-based are equivalent to the nSpire Health ePRO (electronic patient reported outcome)	60 minutes	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.