NCT02753556

Brief Summary

ScreenFlow is a chronic obstructive pulmonary disease (COPD) screening tool currently being studied and iteratively developed that incorporates a questionnaire administered on a tablet and data from a digital peak flow meter to calculate a risk score to identify the risk of developing moderate-to-severe COPD for the participant. The purpose of this study is to assess the usability of ScreenFlow deployed as a free-standing kiosk and observe where users encounter trouble navigating the system. The kiosk will be situated in a public area of a hospital where passersby can approach and fill out a ScreenFlow survey if they meet the eligibility criteria. A subset of participants will be asked to participate in a follow-up questionnaire about their experience using the system and about any follow-up action they may have taken caused by their results from the ScreenFlow screening.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
399

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

February 1, 2018

Status Verified

January 1, 2018

Enrollment Period

9 months

First QC Date

April 25, 2016

Last Update Submit

January 30, 2018

Conditions

Keywords

Chronic Obstructive Pulmonary DiseaseCOPDScreenFlowScreeningLung DiseaseMobile HealthPeak Flow MeterUsability

Outcome Measures

Primary Outcomes (1)

  • Proportion of positive ScreenFlow screens among participants that use system

    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 Outcomes (3)

  • Qualitative feedback on the usability of the ScreenFlow system

    Six weeks

  • Click-based usability testing of the ScreenFlow interface

    Six weeks

  • Proportion of adults exposed to the ScreenFlow system that actually use it

    Six weeks

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants from which possible participants will self-select is of people that pass through the pharmacy entrances at the Boston Medical Center.

You may qualify if:

  • years of age or older, able to use tablet

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveLung Diseases

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2016

First Posted

April 28, 2016

Study Start

September 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

February 1, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share