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Pulmonary Disease Requiring Ambulatory Oxygen Therapy -Resilience and Quality of Life

Pulmonary Disease Requiring Ambulatory Oxygen Therapy -Resilience and Quality of Life

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04554225
Acronym
koti-happi
Enrollment
43
Registered
2020-09-18
Start date
2017-11-01
Completion date
2023-12-31
Last updated
2023-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease

Keywords

resilience, psychological, quality of life, oxygen inhalation therapy, lung diseases

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.

Interventions

Oxygen administered to a patient using ambulatory oxygen

Sponsors

Helsinki University Central Hospital
CollaboratorOTHER
Tampere University Hospital
CollaboratorOTHER
Kuopio University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Health related quality of lifeBaseline (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)

Secondary

MeasureTime frameDescription
Life satisfactionBaseline (Before start of ambulatory oxygen therapy)Life satisfaction questionnaire (4-6 satisfied, 7-11 partly unsatisfied, 12-20 unsatisfied to life)
Usability of ambulatory oxygenAt one monthQUEST- questionnaire (The Quebec User Evaluation of Satisfaction with Assistive Technology) (1=unsatisfied, 4-5 very satisfied)
AnxietyBaseline (Before start of ambulatory oxygen therapy)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)
DepressionBaseline (Before start of ambulatory oxygen therapy)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
SleepinessBaseline (Before start of ambulatory oxygen therapy)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'.

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026