Scanadu Consumer Health Outcomes (SCOUT) Study

NCT02134145 | Completed

• 1 other identifier: Scanadu
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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:
• 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

Outcome Measures

Primary Outcomes (5)

• Participant Characteristics

  1. Device usage and specific parameter usage 2. Use of new technology

  Baseline

• Changes in psychological outcomes as measured by:

  a. Anxiety Levels (Speilberger State-Trait Anxiety Inventory; STAI Y-6 item)

  Baseline, 3 months, 12 months, and 18 months

• Changes in Health Outcomes as measured by:

  1. Patient Activation 2. Health-Related Quality of Life

  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

  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

  3 months, 12 months, and 18 months

Study Arms (1)

Self Selected Investors

A self selected crowdfunding backers from teh Scanadu Scout Crowdfunding campaign.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Over 18 years of age
• Signed Informed Consent Form

You may not qualify if:

• None

Sponsors & Collaborators

• Scripps Translational Science Institute: lead
• Scanadu, Inc.: collaborator

Study Sites (1)

Scripps Translational Science Institute

La Jolla, California, 92037, United States

Location

Study Officials

• Steven Steinhubl, MD

  STSI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Digital Medicine

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: May 9, 2014
• Study Start: January 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: January 20, 2018
• Last Updated: February 28, 2018

Record last verified: 2018-02

Locations

US (1)