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

June 17, 2013 updated by: nSpire Health, Inc.
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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

20

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

COPD Subjects

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

nSpire Health, Inc.

Investigators

  • Study Director: Michelle Vig, MS, nSpire Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

April 22, 2013

First Submitted That Met QC Criteria

June 7, 2013

First Posted (Estimate)

June 11, 2013

Study Record Updates

Last Update Posted (Estimate)

June 19, 2013

Last Update Submitted That Met QC Criteria

June 17, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NSH-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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