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Effective Conversion of Individuals at Risk

Primary Purpose

Obstructive Sleep Apnea, Atrial Fibrillation

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smartphone application use
Sponsored by
Philips Electronics Nederland B.V. acting through Philips CTO organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obstructive Sleep Apnea focused on measuring OSA, AFib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • High risk of OSA and/or AFib, as defined by the risk algorithm developed by Sanford health
  • 18 years or older, with sufficient English language skills
  • Owning a smartphone with a relatively new operating system (iOS v. 14 (Iphone 6S or higher) or an Android device v.11<)
  • Able to download and handle an app on a smartphone
  • Willing and able to give informed consent

Exclusion criteria:

  • Diagnosed with OSA and/or AFib
  • Diagnosed health issues that are potentially life threatening or causing mental issues (stroke, Alzheimer's Disease, depression, etc.)
  • Pregnancy/breast feeding

Sites / Locations

  • Sandford Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Smartphone app use

Outcomes

Primary Outcome Measures

Effective conversion
Number of patients that visited the Primary Care Physician

Secondary Outcome Measures

Full Information

First Posted
October 19, 2021
Last Updated
December 8, 2022
Sponsor
Philips Electronics Nederland B.V. acting through Philips CTO organization
Collaborators
Sanford Health
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1. Study Identification

Unique Protocol Identification Number
NCT05112757
Brief Title
Effective Conversion of Individuals at Risk
Official Title
Effective Conversion of Individuals at Risk
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
Very low recruitment success and all recruitment options were exhausted
Study Start Date
February 24, 2022 (Actual)
Primary Completion Date
December 8, 2022 (Actual)
Study Completion Date
December 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Electronics Nederland B.V. acting through Philips CTO organization
Collaborators
Sanford Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aims to guide participants in recognizing their OSA (obstructive sleep apnea) and AFib (atrial fibrillation) symptoms, realizing what medical conditions can cause these symptoms (if any) and inform the participants on their possible diagnosis
Detailed Description
The primary objective is to analyze how many patients at risk of medical conditions will be converted to a health care professional by a smartphone application. Historical data (number of patients at risk of OSA and/or AFib that seeked help for their condition in the past year) from institute will be used as a reference. We will refer to this as the 'baseline conversion rate', reflecting the natural transition of patients in the general healthcare system.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Atrial Fibrillation
Keywords
OSA, AFib

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Smartphone app use
Intervention Type
Other
Intervention Name(s)
Smartphone application use
Intervention Description
Use of a smartphone application
Primary Outcome Measure Information:
Title
Effective conversion
Description
Number of patients that visited the Primary Care Physician
Time Frame
6 months after consent

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: High risk of OSA and/or AFib, as defined by the risk algorithm developed by Sanford health 18 years or older, with sufficient English language skills Owning a smartphone with a relatively new operating system (iOS v. 14 (Iphone 6S or higher) or an Android device v.11<) Able to download and handle an app on a smartphone Willing and able to give informed consent Exclusion criteria: Diagnosed with OSA and/or AFib Diagnosed health issues that are potentially life threatening or causing mental issues (stroke, Alzheimer's Disease, depression, etc.) Pregnancy/breast feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Weysen, MSc
Organizational Affiliation
Philips Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sandford Health
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effective Conversion of Individuals at Risk

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