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
About this trial
This is an interventional other trial for Obstructive Sleep Apnea focused on measuring OSA, AFib
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
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
NCT ID
NCT05112757
First Posted
October 19, 2021
Last Updated
December 8, 2022
Sponsor
Philips Electronics Nederland B.V. acting through Philips CTO organization
Collaborators
Sanford Health
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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