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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01875302

Enrollment

Registered

2013-06-11

Start date

2013-02-28

Completion date

2013-05-31

Last updated

2013-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Keywords

COPD PRO Instraments equivalency

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Outcome results