An observational study in Disorder Characterized by Fever, sponsored by Scripps Translational Science Institute. Completed at 1 site in United States. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-28.
Sponsored by Scripps Translational Science Institute · Observational
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:
Data analysis will examine individual participant and aggregate level:
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:
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:
Data analysis will examine individual participant and aggregate level:
Scripps Translational Science Institute is the lead sponsor of 52 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will consist of a select cohort of crowdfunding backers for the Scanadu Scout Crowdfunding campaign.
Exclusion Criteria:
A self selected crowdfunding backers from teh Scanadu Scout Crowdfunding campaign.
Participant Characteristics
1. Device usage and specific parameter usage 2. Use of new technology
Time frame: Baseline
Changes in psychological outcomes as measured by:
a. Anxiety Levels (Speilberger State-Trait Anxiety Inventory; STAI Y-6 item)
Time frame: Baseline, 3 months, 12 months, and 18 months
Changes in Health Outcomes as measured by:
1. Patient Activation 2. Health-Related Quality of Life
Time frame: Baseline, 3 months, 12 months, and 18 months
Changes in Lifestyle Outcomes as measured by:
1. Medications 2. Food Screener 3. Exercise 4. Health Communication
Time frame: 3 months, 12 months, and 18 months
Perceptions of the Scanadu Scout™ as measured by
1. Satisfaction with technology (Usability and Satisfaction) 2. Device design/labeling assessments
Time frame: 3 months, 12 months, and 18 months
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Scripps Translational Science Institute