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OpenTrials
Completed

NCT Number: NCT02134145

Scanadu Consumer Health Outcomes (SCOUT) Study

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.

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Key information

Conditions

Disorder Characterized by Fever

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Scripps Translational Science Institute

La Jolla, California, 92037, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Over 18 years of age
  • Signed Informed Consent Form

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Participant Characteristics

    Time frame: Baseline

    • Device usage and specific parameter usage
    • 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

    • Patient Activation
    • Health-Related Quality of Life

  4. Changes in Lifestyle Outcomes as measured by:

    Time frame: 3 months, 12 months, and 18 months

    • Medications
    • Food Screener
    • Exercise
    • Health Communication

  5. Perceptions of the Scanadu Scout™ as measured by

    Time frame: 3 months, 12 months, and 18 months

    • Satisfaction with technology (Usability and Satisfaction)
    • Device design/labeling assessments

Sponsors and collaborators

Lead sponsor

Scripps Translational Science Institute

Other

Collaborators

  • Scanadu, Inc.

Registry information

Official study title

Usability Study of the Scanadu Scout

Acronym: SCOUT

Important dates

Study start
2015
Primary completion
2016
Study completion
2018
First posted
May 9, 2014
Registry last updated
Feb 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.