Effective Conversion of Individuals at Risk | NCT05112757

Studies
Effective Conversion of Individuals at Risk

NCT05112757

Sponsor

Philips Electronics Nederland B.V. acting through Philips CTO organization

Status

Terminated

Last Update Posted

Dec 12, 2022Actual

Enrollment

77Actual

Phase

Not Applicable

Conditions

Obstructive Sleep Apnea
Atrial Fibrillation

Interventions

Smartphone application use

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Very low recruitment success and all recruitment options were exhausted

Expanded Access Info

Start Date

Feb 24, 2022Actual

Primary Completion Date

Dec 8, 2022Actual

Completion Date

Dec 8, 2022Actual

First Submitted Date

Oct 19, 2021

First Submission Date that Met QC Criteria

Nov 4, 2021

First Posted Date

Nov 9, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2022

Last Update Posted Date

Dec 12, 2022Actual

Name	Class
Sanford Health	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

77Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	Smartphone app use	Other: Smartphone application use

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Smartphone application use	Other	Use of a smartphone application	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effective conversion	Number of patients that visited the Primary Care Physician	6 months after consent

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tim Weysen, MSc	Philips Healthcare	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sandford Health		Sioux Falls	South Dakota	57105	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided