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

Pulmonary Disease Clinical Trial

— koti-happi  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04554225
• Other study ID #: 507A023
• Status: Active, not recruiting
• Start date: November 1, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 43
• Est. completion date: December 31, 2023
• Est. primary completion date: July 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease

Intervention

Drug:
• Oxygen gas
Oxygen administered to a patient using ambulatory oxygen

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio	Northern Savo

Sponsors (3)

Lead Sponsor	Collaborator
Kuopio University Hospital	Helsinki University Central Hospital, Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Life satisfaction	Life satisfaction questionnaire (4-6 satisfied, 7-11 partly unsatisfied, 12-20 unsatisfied to life)	Baseline (Before start of ambulatory oxygen therapy)
Secondary	Life satisfaction	Life satisfaction questionnaire (4-6 satisfied, 7-11 partly unsatisfied, 12-20 unsatisfied to life)	At 24 months
Secondary	Usability of ambulatory oxygen	QUEST- questionnaire (The Quebec User Evaluation of Satisfaction with Assistive Technology) (1=unsatisfied, 4-5 very satisfied)	At one month
Secondary	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)	Baseline (Before start of ambulatory oxygen therapy)
Secondary	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)	24 months
Secondary	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	Baseline (Before start of ambulatory oxygen therapy)
Secondary	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	At 24 months
Secondary	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'.	Baseline (Before start of ambulatory oxygen therapy)
Secondary	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'.	At 24 months