Clinical trial NCT04554225: Pulmonary Disease Requiring Ambulatory Oxygen Therapy -Resilience and Quality of Life
Official title: Pulmonary Disease Requiring Ambulatory Oxygen Therapy -Resilience and Quality of Life
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Disease
Keywords: resilience
psychological
quality of life
oxygen inhalation therapy
lung diseases
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
name: Tampere University Hospital
First posted: 2020-09-18
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pulmonary disease who start or use ambulatory oxygen therapy

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Health related quality of life
timeFrame: Baseline (Before start of ambulatory oxygen therapy)
measure: Health related quality of life
timeFrame: At 24 months
Secondary outcomes:
measure: Life satisfaction
timeFrame: Baseline (Before start of ambulatory oxygen therapy)
measure: Life satisfaction
timeFrame: At 24 months
measure: Usability of ambulatory oxygen
timeFrame: At one month
measure: Anxiety
timeFrame: Baseline (Before start of ambulatory oxygen therapy)
measure: Anxiety
timeFrame: 24 months
measure: Depression
timeFrame: Baseline (Before start of ambulatory oxygen therapy)
measure: Depression
timeFrame: At 24 months
measure: Sleepiness
timeFrame: Baseline (Before start of ambulatory oxygen therapy)
measure: Sleepiness
timeFrame: At 24 months
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
state: Northern Savo
Study officials:
affiliation: Kuopio University Hospital
name: Merja Kokki, V
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.