NCT05440188

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 30, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2023

Completed
Last Updated

December 6, 2023

Status Verified

November 1, 2023

Enrollment Period

11 months

First QC Date

June 27, 2022

Last Update Submit

November 29, 2023

Conditions

Keywords

telemedicine

Outcome Measures

Primary Outcomes (1)

  • Number of hospital admissions due to exacerbations

    24 weeks

Study Arms (1)

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

Breath Detect PlatformDIAGNOSTIC_TEST

Use of the Breath Detect platform for respiratory health monitoring.

COPD

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • COPD diagnosed in GOLD II state or higher

You may not qualify if:

  • Can´t read and talk in spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CS Entrevías

Madrid, 28053, Spain

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 27, 2022

First Posted

June 30, 2022

Study Start

October 1, 2022

Primary Completion

August 23, 2023

Study Completion

October 23, 2023

Last Updated

December 6, 2023

Record last verified: 2023-11

Locations