Pulmonary Diseasekoti-happiNCT04554225
Pulmonary Disease Requiring Ambulatory Oxygen Therapy -Resilience and Quality of Life
An observational study of Pulmonary Disease, run by Kuopio University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease
- What is being tested?
- Oxygen gas
- How many people
- 43 participants
- Where
- 1 siteFinland
- Study dates
- 1 Nov 2017to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pulmonary disease who start or use ambulatory oxygen therapy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Dyspnea is a common symptom in pulmonary disease patients, such as chronic obstructive pulmonary disease (COPD) and interstitial lung diseases. These patients often have low health-related quality of life (HRQoL) and life satisfaction (LS), and high levels of anxiety and depression.
Oxygen therapy is used in severe pulmonary diseases to improve HRQoL and prolong survival. Ambulatory oxygen therapy is prescribed to patients who become transiently hypoxemic, e.g. during exercise or normal outdoors activities. However, only 46 % of COPD patients were adherent to long-term oxygen therapy. Proper adaptation to a serious illness, such as advanced COPD and interstitial lung diseases, necessitates resilience. Resilience is an ability to adapt appropriately in difficulties in life. This ability is based on a person's psychological resources, and it can be learned and improved with time and effort. Evaluation of resilience is commonly applied in psychological examinations and research, but less attention has been paid in medical context even though resilience capacity is closely connected to recovery abilities and adaptation.
The main aim is to measure resilience in pulmonary disease patients receiving ambulatory oxygen therapy and how it correlates with other measures of HRQoL and LS. Also anxiety and depression are surveyed and satisfaction to ambulatory oxygen therapy devices and associated services.Investigators also compare the HRQoL of pulmonary disease patients receiving ambulatory oxygen therapy to an age and gender matched sample of the general population. Primary outcome measure was the proportion of patients with low resilience, and secondary outcomes were how resilience correlated with HRQoL, LS, anxiety and depression in patients prescribed ambulatory oxygen therapy.
- Conditions
- Pulmonary Disease
- Being tested
- Oxygen gas
- Keywords
- resilience, psychological, quality of life, oxygen inhalation therapy, lung diseases
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen gasDrug
Also called ambulatory oxygen
Oxygen administered to a patient using ambulatory oxygen
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary disease patients | Patients with COPD or other pulmonary disease starting to use ambulatory oxygen therapy Receives: Drug: Oxygen gas |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: At 24 months
Secondary outcomes (9)
Life satisfaction
Life satisfaction questionnaire (4-6 satisfied, 7-11 partly unsatisfied, 12-20 unsatisfied to life)
Measured: Baseline (Before start of ambulatory oxygen therapy)
Life satisfaction
Life satisfaction questionnaire (4-6 satisfied, 7-11 partly unsatisfied, 12-20 unsatisfied to life)
Measured: At 24 months
Usability of ambulatory oxygen
QUEST- questionnaire (The Quebec User Evaluation of Satisfaction with Assistive Technology) (1=unsatisfied, 4-5 very satisfied)
Measured: At one month
Anxiety
GAD-7 (General Anxiety Disorder-7)- questionnaire (GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety)
Measured: Baseline (Before start of ambulatory oxygen therapy)
Anxiety
GAD-7- questionnaire (General Anxiety Disorder-7) (GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety)
Measured: 24 months
Depression
General Health Questionnaire12 (1= worse or much worse that usually, 0= as usual/much better than usual, points: 0-12, 3 or more points = depression and DEPS- (depression scale) questionnaires (0-30 points, 12 points means that 50% have depression
Measured: Baseline (Before start of ambulatory oxygen therapy)
Depression
General Health Questionnaire 12 (1= worse or much worse that usually, 0= as usual/much better than usual, points: 0-12, 3 or more points = depression and DEPS- questionnaires (0-30 points, 12 points means that 50% have depression
Measured: At 24 months
Sleepiness
Epworth Sleepiness Scale, ESS (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.
Measured: Baseline (Before start of ambulatory oxygen therapy)
Sleepiness
Epworth Sleepiness Scale, ESS (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.
Measured: At 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start1 Nov 2017
- Primary completion29 Jul 2022
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Merja Kokki, V, Principal investigator, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554225
- Sponsor's protocol ID
- 507A023
- Acronym
- koti-happi
- Status last verified
- Mar 2023
- First submitted
- 26 Aug 2020
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40616033Isokaanta 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.
PubMed 33933036
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Disease Requiring Ambulatory Oxygen Therapy -Resilience and Quality of Life
- ClinicalTrials.gov ID
- NCT04554225
- Acronym / sponsor ID
- koti-happi / 507A023
- Conditions
- Pulmonary Disease
- Keywords
- resilience, psychological, quality of life, oxygen inhalation therapy, lung diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital, Tampere University Hospital
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 29 Jul 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Dyspnea is a common symptom in pulmonary disease patients, such as chronic obstructive pulmonary disease (COPD) and interstitial lung diseases. These patients often have low health-related quality of life (HRQoL) and life satisfaction (LS), and high levels of anxiety and depression.
Oxygen therapy is used in severe pulmonary diseases to improve HRQoL and prolong survival. Ambulatory oxygen therapy is prescribed to patients who become transiently hypoxemic, e.g. during exercise or normal outdoors activities. However, only 46 % of COPD patients were adherent to long-term oxygen therapy. Proper adaptation to a serious illness, such as advanced COPD and interstitial lung diseases, necessitates resilience. Resilience is an ability to adapt appropriately in difficulties in life. This ability is based on a person's psychological resources, and it can be learned and improved with time and effort. Evaluation of resilience is commonly applied in psychological examinations and research, but less attention has been paid in medical context even though resilience capacity is closely connected to recovery abilities and adaptation.
The main aim is to measure resilience in pulmonary disease patients receiving ambulatory oxygen therapy and how it correlates with other measures of HRQoL and LS. Also anxiety and depression are surveyed and satisfaction to ambulatory oxygen therapy devices and associated services.Investigators also compare the HRQoL of pulmonary disease patients receiving ambulatory oxygen therapy to an age and gender matched sample of the general population. Primary outcome measure was the proportion of patients with low resilience, and secondary outcomes were how resilience correlated with HRQoL, LS, anxiety and depression in patients prescribed ambulatory oxygen therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary disease patients | – | Drug: Oxygen gasPatients with COPD or other pulmonary disease starting to use ambulatory oxygen therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pulmonary disease who start or use ambulatory oxygen therapy
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygen gasAlso: ambulatory oxygenOxygen administered to a patient using ambulatory oxygen | Drug | Pulmonary disease patients |
Primary outcome
Health related quality of life
Time frame: Baseline (Before start of ambulatory oxygen therapy)
15-D - health related quality of life measurement (0= the worst quality of life, 1= the best quality of life)
Health related quality of life
Time frame: At 24 months
15-D - health related quality of life measurement (0=the worst quality of life, 1= the best quality of life)
9 secondary outcomes
Life satisfaction
Time frame: Baseline (Before start of ambulatory oxygen therapy)
Life satisfaction
Time frame: At 24 months
Usability of ambulatory oxygen
Time frame: At one month
Anxiety
Time frame: Baseline (Before start of ambulatory oxygen therapy)
Anxiety
Time frame: 24 months
Depression
Time frame: Baseline (Before start of ambulatory oxygen therapy)
Depression
Time frame: At 24 months
Sleepiness
Time frame: Baseline (Before start of ambulatory oxygen therapy)
Sleepiness
Time frame: At 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Derived from this study: PubMed 40616033Isokaanta 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.
- Derived from this study: PubMed 33933036Isokaanta 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merja Kokki, V principal investigator
Kuopio University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, run by Kuopio University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related quality of life (time frame: Baseline (Before start of ambulatory oxygen therapy)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04554225, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.