Effective Conversion of Individuals at Risk

• Sponsor: Philips Electronics Nederland B.V. acting through Philips CTO organization (Industry)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05112757
• Collaborator: Sanford Health (Other)
• Enrollment: 400
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 9.2
• Patients Per Site Per Month: 43.5

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea; Atrial Fibrillation	Other: Smartphone application use	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Effective Conversion of Individuals at Risk
• Actual Study Start Date: Feb 24, 2022
• Anticipated Primary Completion Date: Nov 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Smartphone app use	Other: Smartphone application use; Use of a smartphone application

Outcome Measures

Primary Outcome Measures

1. Effective conversion [6 months after consent]

   Number of patients that visited the Primary Care Physician

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sandford Health	Sioux Falls	South Dakota	United States	57105

Sponsors and Collaborators

• Philips Electronics Nederland B.V. acting through Philips CTO organization
• Sanford Health

Investigators

• Principal Investigator: Tim Weysen, MSc, Philips Healthcare

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Philips Electronics Nederland B.V. acting through Philips CTO organization
• ClinicalTrials.gov Identifier: NCT05112757
• Other Study ID Numbers: ICBE-S-000283
• First Posted: Nov 9, 2021
• Last Update Posted: Apr 26, 2022
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Philips Electronics Nederland B.V. acting through Philips CTO organization: OSA; AFib
• Additional relevant MeSH terms: Sleep Apnea, Obstructive; Atrial Fibrillation

Study Results

No Results Posted as of Apr 26, 2022