Pulmonary Disease, Chronic ObstructiveNCT02753556
ScreenFlow: Strategy for Finding Cases of Moderate-to-Severe COPD
An observational study of Pulmonary Disease, Chronic Obstructive, run by Dimagi Inc..
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- How many people
- 399 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants from which possible participants will self-select is of people that pass through the pharmacy entrances at the Boston Medical Center.
Who may be able to join
- 40 years of age or older, able to use tablet
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, ScreenFlow, Screening, Lung Disease, Mobile Health, Peak Flow Meter, Usability
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Six weeks
Secondary outcomes (3)
Qualitative feedback on the usability of the ScreenFlow system
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.
Measured: Six weeks
Click-based usability testing of the ScreenFlow interface
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.
Measured: Six weeks
Proportion of adults exposed to the ScreenFlow system that actually use it
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.
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startSep 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 399 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dimagi Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boston Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753556
- Sponsor's protocol ID
- HHSN268201400046C
- Status last verified
- Jan 2018
- First submitted
- 25 Apr 2016
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ScreenFlow: Strategy for Finding Cases of Moderate-to-Severe COPD
- ClinicalTrials.gov ID
- NCT02753556
- Acronym / sponsor ID
- HHSN268201400046C
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, ScreenFlow, Screening, Lung Disease, Mobile Health, Peak Flow Meter, Usability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 399 participants (actual)
- Lead sponsor
- Dimagi Inc.Industry (pharma, biotech, devices)
- Collaborators
- Boston Medical Center
- Study start
- Sep 2015 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants from which possible participants will self-select is of people that pass through the pharmacy entrances at the Boston Medical Center.
Key inclusion criteria (1 listed)
- 40 years of age or older, able to use tablet
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Qualitative feedback on the usability of the ScreenFlow system
Time frame: Six weeks
Click-based usability testing of the ScreenFlow interface
Time frame: Six weeks
Proportion of adults exposed to the ScreenFlow system that actually use it
Time frame: Six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by Dimagi Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of positive ScreenFlow screens among participants that use system (time frame: Six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2018.