Study to Identify the Reduction of Exacerbations Resultin... | NCT05440188

Studies
Study to Identify the Reduction of Exacerbations Resulting in Hospital Admission in Patients With COPD.

NCT05440188

Sponsor

Universidad Autonoma de Madrid

Status

Completed

Last Update Posted

Dec 6, 2023Actual

Enrollment

80Actual

Phase

Not provided

Conditions

COPD Exacerbation

Interventions

Breath Detect Platform

Countries

Spain

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

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2022Actual

Primary Completion Date

Aug 23, 2023Actual

Completion Date

Oct 23, 2023Actual

First Submitted Date

Jun 27, 2022

First Submission Date that Met QC Criteria

Jun 27, 2022

First Posted Date

Jun 30, 2022Actual

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

Nov 29, 2023

Last Update Posted Date

Dec 6, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Raúl Ferrer-Peña, Principal Investigator, Universidad Autonoma de MadridPrincipal Investigator

Lead Sponsor

Universidad Autonoma de MadridOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

identification of the reduction of exacerbations resulting in hospital admission in COPD patients after the use of the Breath Detect telemedicine platform.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COPD		Patients over 65 years old diagnosed with COPD in GOLD II state or higher who uses Breath Detect Platform for monitoring their respiratory health status.	Diagnostic Test: Breath Detect Platform

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Breath Detect Platform	Diagnostic Test	Use of the Breath Detect platform for respiratory health monitoring.	COPD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of hospital admissions due to exacerbations		24 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

COPD diagnosed in GOLD II state or higher

Exclusion Criteria:

Can´t read and talk in spanish

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Patients from Primary Health Care, Elderly care homes, and HULP

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CS Entrevías		Madrid		28053	Spain

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided