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

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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

nSpire Health, Inc.

Industry

Registry information

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Jun 11, 2013
Registry last updated: Jun 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed