- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02753556
ScreenFlow: Strategy for Finding Cases of Moderate-to-Severe COPD
Study Overview
Status
Conditions
Detailed Description
This is a cross-sectional study to determine the usability of ScreenFlow deployed as a kiosk. As such, everyone who uses ScreenFlow will be asked to complete a brief questionnaire on its features including visual appeal and ease of use. Additionally, a subset of 36 subjects whose estimated ScreenFlow risk of moderate-to-severe COPD is high will be asked to participate in a follow up phone questionnaire to ascertain, a) whether screening results were discussed with the subjects' health provider, b) impact of the ScreenFlow results on health behavior, c) whether the individual shared the ScreenFlow result with his/her health provider (or intention to share the result), and d) any action that may have been taken by the medical provider after the provider received the report.
The ScreenFlow platform will be available in a common area of Boston Medical Center over the course of six weeks, under the supervision of a study staff member. The platform will be available to the public during regular business hours from Monday to Friday. Subjects will complete a ScreenFlow screening by answering some questions, watching a video and performing peak flow measurement as instructed in the video. They will be given a report of the ScreenFlow result indicating whether there is a high probability of having moderate to severe COPD. Over six weeks, approximately 3600 patients should come in contact with the kiosk. Conservatively, we estimate that if 10% of them use it, we will have 360 users, of which 10% may have a high risk score on screening. This will give the desired sample size of 36 patients for the phone based follow-up interview.
Thirty-six subjects will give their feedback through a phone based follow-up interview with a study staff member to assess how ScreenFlow may have influenced their subsequent medical care. We will consent 36 subjects for these follow-up calls, with the expectation that some may be difficult to reach or may decline to participate in the follow-up call.
In the interview we will ask whether the participants discussed COPD with their primary care providers, and the extent to which their care may have been influenced by this screening result. For those who have not had the opportunity to share results with their provider by the time of the follow-up call, we will ask about the effect of the positive screening result on their perception of COPD risk, intention to notify their provider, and health behavior.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 40 years of age or older, able to use tablet
Exclusion Criteria:
- History of pneumothorax or collapsed lung, surgery in the past 6 months (oral, eye, chest, abdomen), non-English speaking, signs and symptoms of an active upper respiratory tract infection, legally blind and/or deaf
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of positive ScreenFlow screens among participants that use system
Time Frame: Six weeks
|
Out of the entirety of screening results for all participants that use the ScreenFlow system during the study, calculation of the proportion of "positive" screens
|
Six weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Qualitative feedback on the usability of the ScreenFlow system
Time Frame: Six weeks
|
Each participant that uses the ScreenFlow system will be asked to complete a qualitative survey upon completion of the ScreenFlow questionnaire.
The survey will focus on the user experience and usability of the ScreenFlow system.
|
Six weeks
|
Click-based usability testing of the ScreenFlow interface
Time Frame: Six weeks
|
During each session a participant completes using the ScreenFlow system, we will track each touch on the tablet screen, including the time it takes for a user to make each touch.
This will provide input into questions that may be confusing to users, and interface designs that may not be intuitive.
|
Six weeks
|
Proportion of adults exposed to the ScreenFlow system that actually use it
Time Frame: Six weeks
|
We will track the number of adults that are "exposed" wherein they pass by or see the ScreenFlow kiosk, and also keep track of how many "exposed" adult then opt to approach and use the system.
|
Six weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HHSN268201400046C
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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