Disorder Characterized by FeverSCOUTNCT02134145
Scanadu Consumer Health Outcomes (SCOUT) Study
An observational study of Disorder Characterized by Fever, run by Scripps Translational Science Institute at 1 site in United States.
Trial summary
There is a great need within healthcare to develop systems of care that better engage and activate people in their own care before they become patients. By so doing lay users will be empowered to take charge of their own care in recognizing they can change their health and improve their quality of life. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Disorder Characterized by Fever
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 20 Jan 2018
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of a select cohort of crowdfunding backers for the Scanadu Scout Crowdfunding campaign.
Who may be able to join
- Over 18 years of age
- Signed Informed Consent Form
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Scripps Translational Science Institute
La Jolla, California, 92037
About this study
Official title: Usability Study of the Scanadu Scout
There is a great need within healthcare to develop systems of care that better engage and activate people in their own care before they become patients. By so doing lay users will be empowered to take charge of their own care in recognizing they can change their health and improve their quality of life. Mobile health technologies such as the Scanadu ScoutTM hold the potential to truly engage individuals in the way needed through real-time data capture, transmission and connectivity.
We propose to evaluate the real-world use of the Scanadu ScoutTM by a cohort of self-selected investors in an earlier crowdfunding campaign on Indiegogo for the Scanadu Scout™, through a prospective observational study. Using validated survey tools and through the remote tracking of frequency of use and physiological measurements from the Scanadu Scout™ device and app.
Read more
Participants will receive web-based surveys at 4 time points: baseline, 3, 12 and 18 months.
Participants will be instructed to use the Scanadu Scout™ as much as they would like. The parameters that will be functional on the device and available for measurement by the participant are:
- Heart rate
- Respiratory rate
- Temperature
- Oxygen saturation
- Heart rate variability
- Blood pressure
Data analysis will examine individual participant and aggregate level:
- Usage and physiologic measurement data of the device,
- Perceptions of the device, and
- Changes in self-reported health self-management, health-related quality of life, participant- physician communication and medication adherence between baseline and follow-up.
Read the detailed description
We propose to evaluate the real-world use of the Scanadu ScoutTM by a cohort of self-selected investors in an earlier crowdfunding campaign on Indiegogo for the Scanadu Scout™, through a prospective observational study. Using validated survey tools and through the remote tracking of frequency of use and physiological measurements from the Scanadu Scout™ device and app, this study will provide preliminary evidence for:
- Level of engagement and impact of Scanadu ScoutTM on health behavior with a focus on potential risks and safety.
- Long term (up to 18 months) recurrent usage rate of the various physiologic measurements linked to users and survey data.
- Ease of use and acceptance of the Scanadu ScoutTM technology.
This study will utilize a longitudinal cohort design. All Scanadu Scout investors (~5000 individuals) will be invited to participate in the study prior to receiving their Scanadu Scout™. Potential participants will receive a link to an online study platform. The platform will contain the Informed Consent form and all the study materials. After a participant reads and signs the Consent the participant will be enrolled in the study and a Scanadu Scout™ device will be sent. The participant will download the Scanadu Scout™ app from the App Stores (iOS/Android). The app will require a handshake with a Scanadu Scout™ device before it becomes fully functional to limit access to study participants.
After signing the Informed Consent form the participant will be asked to complete baseline surveys to assess participant characteristics, health self-management and health-related quality of life prior to using the Scanadu Scout™. At 3 months, 12 months, and at 18 months, a participant will be asked to complete Health Self-Management and Health-Related QOL surveys as well as an additional assessment of their perceptions of the device. Backers who do not wish to partake in this study will not receive the device and will be entitled to get their contribution back.
Participants will be instructed to use the device as much as they would like over the course of the study. The parameters that will be functional on the device and available for measurement by the participant are:
- Heart rate
- Respiratory rate
- Temperature
- Oxygen saturation
- Heart rate variability
- Blood pressure
Data analysis will examine individual participant and aggregate level:
- Usage and physiologic measurement data of the device,
- Perceptions of the device, and
- Changes in self-reported health self-management, health-related quality of life, participant- physician communication and medication adherence between baseline and follow-up.
- Conditions
- Disorder Characterized by Fever
- Keywords
- Mobile Health, mHealth, Technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Self Selected Investors | A self selected crowdfunding backers from teh Scanadu Scout Crowdfunding campaign. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Characteristics
- Device usage and specific parameter usage
- Use of new technology
Measured: Baseline
Changes in psychological outcomes as measured by:
- Anxiety Levels (Speilberger State-Trait Anxiety Inventory; STAI Y-6 item)
Measured: Baseline, 3 months, 12 months, and 18 months
Changes in Health Outcomes as measured by:
- Patient Activation
- Health-Related Quality of Life
Measured: Baseline, 3 months, 12 months, and 18 months
Changes in Lifestyle Outcomes as measured by:
- Medications
- Food Screener
- Exercise
- Health Communication
Measured: 3 months, 12 months, and 18 months
Perceptions of the Scanadu Scout™ as measured by
- Satisfaction with technology (Usability and Satisfaction)
- Device design/labeling assessments
Measured: 3 months, 12 months, and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startJan 2015
- Primary completionNov 2016
- Study completion20 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder Characterized by FeverStudies 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
- Prospective
- Enrolment
- 5,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Translational Science Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Scanadu, Inc.
- Responsible party
- Principal investigator, Steven Steinhubl, Scripps Translational Science Institute
- Investigators
- Steven Steinhubl, MD, Principal investigator, STSI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134145
- Sponsor's protocol ID
- Scanadu
- Acronym
- SCOUT
- Status last verified
- Feb 2018
- First submitted
- 7 May 2014
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability Study of the Scanadu Scout
- ClinicalTrials.gov ID
- NCT02134145
- Acronym / sponsor ID
- SCOUT / Scanadu
- Conditions
- Disorder Characterized by Fever
- Keywords
- Mobile Health, mHealth, Technology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- Scripps Translational Science InstituteUniversity, hospital or other
- Collaborators
- Scanadu, Inc.
- Study start
- Jan 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- 20 Jan 2018 (actual)
- First posted
- 9 May 2014 (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.
There is a great need within healthcare to develop systems of care that better engage and activate people in their own care before they become patients. By so doing lay users will be empowered to take charge of their own care in recognizing they can change their health and improve their quality of life. Mobile health technologies such as the Scanadu ScoutTM hold the potential to truly engage individuals in the way needed through real-time data capture, transmission and connectivity.
We propose to evaluate the real-world use of the Scanadu ScoutTM by a cohort of self-selected investors in an earlier crowdfunding campaign on Indiegogo for the Scanadu Scout™, through a prospective observational study. Using validated survey tools and through the remote tracking of frequency of use and physiological measurements from the Scanadu Scout™ device and app.
Participants will receive web-based surveys at 4 time points: baseline, 3, 12 and 18 months.
Participants will be instructed to use the Scanadu Scout™ as much as they would like. The parameters that will be functional on the device and available for measurement by the participant are:
- Heart rate
- Respiratory rate
- Temperature
- Oxygen saturation
- Heart rate variability
- Blood pressure
Data analysis will examine individual participant and aggregate level:
- Usage and physiologic measurement data of the device,
- Perceptions of the device, and
- Changes in self-reported health self-management, health-related quality of life, participant- physician communication and medication adherence between baseline and follow-up.
Detailed description
We propose to evaluate the real-world use of the Scanadu ScoutTM by a cohort of self-selected investors in an earlier crowdfunding campaign on Indiegogo for the Scanadu Scout™, through a prospective observational study. Using validated survey tools and through the remote tracking of frequency of use and physiological measurements from the Scanadu Scout™ device and app, this study will provide preliminary evidence for:
- Level of engagement and impact of Scanadu ScoutTM on health behavior with a focus on potential risks and safety.
- Long term (up to 18 months) recurrent usage rate of the various physiologic measurements linked to users and survey data.
- Ease of use and acceptance of the Scanadu ScoutTM technology.
This study will utilize a longitudinal cohort design. All Scanadu Scout investors (~5000 individuals) will be invited to participate in the study prior to receiving their Scanadu Scout™. Potential participants will receive a link to an online study platform. The platform will contain the Informed Consent form and all the study materials. After a participant reads and signs the Consent the participant will be enrolled in the study and a Scanadu Scout™ device will be sent. The participant will download the Scanadu Scout™ app from the App Stores (iOS/Android). The app will require a handshake with a Scanadu Scout™ device before it becomes fully functional to limit access to study participants.
After signing the Informed Consent form the participant will be asked to complete baseline surveys to assess participant characteristics, health self-management and health-related quality of life prior to using the Scanadu Scout™. At 3 months, 12 months, and at 18 months, a participant will be asked to complete Health Self-Management and Health-Related QOL surveys as well as an additional assessment of their perceptions of the device. Backers who do not wish to partake in this study will not receive the device and will be entitled to get their contribution back.
Participants will be instructed to use the device as much as they would like over the course of the study. The parameters that will be functional on the device and available for measurement by the participant are:
- Heart rate
- Respiratory rate
- Temperature
- Oxygen saturation
- Heart rate variability
- Blood pressure
Data analysis will examine individual participant and aggregate level:
- Usage and physiologic measurement data of the device,
- Perceptions of the device, and
- Changes in self-reported health self-management, health-related quality of life, participant- physician communication and medication adherence between baseline and follow-up.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self Selected Investors | – | –A self selected crowdfunding backers from teh Scanadu Scout Crowdfunding campaign. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of a select cohort of crowdfunding backers for the Scanadu Scout Crowdfunding campaign.
Key inclusion criteria (2 listed)
- Over 18 years of age
- Signed Informed Consent Form
Key exclusion criteria (1 listed)
- None
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
Participant Characteristics
Time frame: Baseline
1. Device usage and specific parameter usage 2. Use of new technology
Changes in psychological outcomes as measured by:
Time frame: Baseline, 3 months, 12 months, and 18 months
a. Anxiety Levels (Speilberger State-Trait Anxiety Inventory; STAI Y-6 item)
Changes in Health Outcomes as measured by:
Time frame: Baseline, 3 months, 12 months, and 18 months
1. Patient Activation 2. Health-Related Quality of Life
Changes in Lifestyle Outcomes as measured by:
Time frame: 3 months, 12 months, and 18 months
1. Medications 2. Food Screener 3. Exercise 4. Health Communication
Perceptions of the Scanadu Scout™ as measured by
Time frame: 3 months, 12 months, and 18 months
1. Satisfaction with technology (Usability and Satisfaction) 2. Device design/labeling assessments
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 28 Feb 2018.
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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.
Steven Steinhubl, MD principal investigator
STSI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disorder Characterized by Fever, run by Scripps Translational Science Institute at 1 site in United States.
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 2 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 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Participant Characteristics (time frame: Baseline). The study lists 5 primary outcomes in all. 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 28 Feb 2018.