NCT04554225

Brief Summary

Dyspnea is common symptom in pulmonary diseases, like chronic obstructive pulmonary disease (COPD) or other pulmonary disease. Ambulatory oxygen therapy is often prescribed to these patients. In these patients resilience, health related quality of life, life satisfaction are measured and the effect and patient satisfaction to ambulatory oxygen therapy are studied.

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
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

November 1, 2017

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2022

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

October 26, 2023

Status Verified

March 1, 2023

Enrollment Period

4.7 years

First QC Date

August 26, 2020

Last Update Submit

October 25, 2023

Conditions

Keywords

resiliencepsychologicalquality of lifeoxygen inhalation therapylung diseases

Outcome Measures

Primary Outcomes (2)

  • Health related quality of life

    15-D - health related quality of life measurement (0= the worst quality of life, 1= the best quality of life)

    Baseline (Before start of ambulatory oxygen therapy)

  • Health related quality of life

    15-D - health related quality of life measurement (0=the worst quality of life, 1= the best quality of life)

    At 24 months

Secondary Outcomes (9)

  • Life satisfaction

    Baseline (Before start of ambulatory oxygen therapy)

  • Life satisfaction

    At 24 months

  • Usability of ambulatory oxygen

    At one month

  • Anxiety

    Baseline (Before start of ambulatory oxygen therapy)

  • Anxiety

    24 months

  • +4 more secondary outcomes

Study Arms (1)

Pulmonary disease patients

Patients with COPD or other pulmonary disease starting to use ambulatory oxygen therapy

Drug: Oxygen gas

Interventions

Oxygen administered to a patient using ambulatory oxygen

Also known as: ambulatory oxygen
Pulmonary disease patients

Eligibility Criteria

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

Patients with pulmonary disease who start or use ambulatory oxygen therapy

You may qualify if:

  • Patient with pulmonary disease (e.g. COPD) who has ambulatory oxygen
  • Patient with pulmonary disease (e.g. COPD) who is starting to use ambulatory oxygen
  • Adult patient
  • Informed consent of the patient received

You may not qualify if:

  • Ambulatory oxygen prescribe for treatment of other than pulmonary disease.
  • Age less than 18 years
  • Dementia or other cognitive impairment that disables understanding of the study
  • No informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuopio University Hospital

Kuopio, Northern Savonia, 70029, Finland

Location

Related Publications (2)

  • Isokaanta S, Kokki H, Sintonen H, Kokki M. Resilience and health-related quality of life in patients with pulmonary diseases receiving ambulatory oxygen therapy - 24-month follow-up results. BMC Pulm Med. 2025 Jul 4;25(1):326. doi: 10.1186/s12890-025-03778-8.

  • Isokaanta S, Honkalampi K, Kokki H, Sintonen H, Kokki M. Resilience and health-related quality of life in patients with pulmonary diseases receiving ambulatory oxygen therapy. BMC Pulm Med. 2021 May 1;21(1):144. doi: 10.1186/s12890-021-01515-5.

MeSH Terms

Conditions

Lung Diseases

Interventions

nitrox

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Merja Kokki, V

    Kuopio University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 26, 2020

First Posted

September 18, 2020

Study Start

November 1, 2017

Primary Completion

July 29, 2022

Study Completion

December 31, 2023

Last Updated

October 26, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations