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

NCT ID: NCT01875302

Last Updated: 2013-06-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-05-31

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.

Conditions

COPD

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

nSpire Health, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle Vig, MS

Role: STUDY_DIRECTOR

nSpire Health

Other Identifiers

NSH-001

Identifier Type: -

Identifier Source: org_study_id