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Scanadu Consumer Health Outcomes (SCOUT) Study (SCOUT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02134145
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : February 28, 2018
Sponsor:
Collaborator:
Scanadu, Inc.
Information provided by (Responsible Party):
Steven Steinhubl, Scripps Translational Science Institute

Study Description
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Brief 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. 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:

  1. Usage and physiologic measurement data of the device,
  2. Perceptions of the device, and
  3. Changes in self-reported health self-management, health-related quality of life, participant- physician communication and medication adherence between baseline and follow-up.

Condition or disease
Disorder Characterized by Fever

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:

  1. Level of engagement and impact of Scanadu ScoutTM on health behavior with a focus on potential risks and safety.
  2. Long term (up to 18 months) recurrent usage rate of the various physiologic measurements linked to users and survey data.
  3. 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:

  1. Usage and physiologic measurement data of the device,
  2. Perceptions of the device, and
  3. 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
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Study Type : Observational
Actual Enrollment : 5000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Usability Study of the Scanadu Scout
Study Start Date : January 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : January 20, 2018
Groups and Cohorts
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Group/Cohort
Self Selected Investors
A self selected crowdfunding backers from teh Scanadu Scout Crowdfunding campaign.


Outcome Measures
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Primary Outcome Measures :
  1. Participant Characteristics [ Time Frame: Baseline ]
    1. Device usage and specific parameter usage
    2. Use of new technology

  2. 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)

  3. 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

  4. 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

  5. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population will consist of a select cohort of crowdfunding backers for the Scanadu Scout Crowdfunding campaign.
Criteria

Inclusion Criteria:

  • Over 18 years of age
  • Signed Informed Consent Form

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134145


Locations
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United States, California
Scripps Translational Science Institute
La Jolla, California, United States, 92037
Sponsors and Collaborators
Scripps Translational Science Institute
Scanadu, Inc.
Investigators
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Principal Investigator: Steven Steinhubl, MD STSI
More Information
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Responsible Party: Steven Steinhubl, Director, Digital Medicine, Scripps Translational Science Institute
ClinicalTrials.gov Identifier: NCT02134145    
Other Study ID Numbers: Scanadu
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Keywords provided by Steven Steinhubl, Scripps Translational Science Institute:
Mobile Health
mHealth
Technology