NCT02791451

Brief Summary

This is an open-label single-center 6-month prospective clinical trial predicting exacerbation of COPD with wireless telemonitoring of respiratory rate, heart rate and sleep in patients admitted to the pulmonary ward of the Turku University Hospital due to acute exacerbation of COPD.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Status
terminated

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 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 15, 2021

Status Verified

April 1, 2021

Enrollment Period

1.2 years

First QC Date

June 1, 2016

Last Update Submit

April 12, 2021

Conditions

COPD

Keywords

COPDtelemonitoringexacerbation

Outcome Measures

Primary Outcomes (1)

  • Time window to detect acute exacerbation of COPD

    Time window to detect acute exacerbation of COPD

    Six months

Study Arms (1)

Telemonitoring

EXPERIMENTAL

Exacerbation of COPD with wireless telemonitoring of respiratory rate, heart rate and sleep.

Device: telemonitoring

Interventions

telemonitoringDEVICE

To predict exacerbation of COPD with wireless telemonitoring

Telemonitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consecutive patients treated due to acute exacerbation of COPD at the pulmonary wards of the Turku University Hospital

You may not qualify if:

  • Those sleeping with a bed partner and not having separate mattresses
  • Patients with pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2016

First Posted

June 6, 2016

Study Start

October 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

April 15, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share