NCT03937622

Brief Summary

This is a prospective multicenter observational trial. Included patients and attending physician complete a standardized questionnaire.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

May 2, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

July 2, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2021

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

2 years

First QC Date

May 2, 2019

Last Update Submit

August 6, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Validation of indication of Long-term Oxygen therapy (LTOT)

    Aim of this study is to observe the real-world handling with longterm Oxygen treatment in northern Germany

    12 month

Interventions

This is a prospective multicenter observational trial. Included patients and attending physician complete a standardised questionnaire.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients fulfilling the Inclusion criteria and not the exclusion criteria at 3 Centers in nothern Germany

You may qualify if:

  • Patients with chronic lung disease, age \> 18 years
  • Established domiciliary LTOT \> 4 weeks
  • Scheduled for control of oxygen therapy with arterial/capillary

You may not qualify if:

  • No informed consent
  • Pulmonary exacerbation within the last 2 weeks
  • Signs of heart failure (edema, congestion)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dep. Respiratory Medicine, Hannover Medical School

Hanover, 30625, Germany

RECRUITING

Department of Respiratory Medicine, Medizinische Hochschule Hannover

Hanover, 30625, Germany

RECRUITING

Study Officials

  • Jens Gottlieb, Prof. Dr. med.

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Fühner, PD Dr. med.

CONTACT

Heiko Golpon, PD Dr. med.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2019

First Posted

May 6, 2019

Study Start

July 2, 2019

Primary Completion

June 20, 2021

Study Completion

September 20, 2021

Last Updated

August 7, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

No sharing of individual participants data

Locations