Pulmonary Disease Requiring Ambulatory Oxygen Therapy -Resilience and Quality of Life
- Registration Number
- NCT04554225
- Lead Sponsor
- Kuopio University Hospital
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 43
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pulmonary disease patients Oxygen gas Patients with COPD or other pulmonary disease starting to use ambulatory oxygen therapy
- Primary Outcome Measures
Name Time Method Health related quality of life At 24 months 15-D - health related quality of life measurement (0=the worst quality of life, 1= the best quality of life)
- Secondary Outcome Measures
Name Time Method Life satisfaction At 24 months Life satisfaction questionnaire (4-6 satisfied, 7-11 partly unsatisfied, 12-20 unsatisfied to life)
Usability of ambulatory oxygen At one month QUEST- questionnaire (The Quebec User Evaluation of Satisfaction with Assistive Technology) (1=unsatisfied, 4-5 very satisfied)
Anxiety 24 months 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)
Depression At 24 months 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
Sleepiness At 24 months 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'.
Trial Locations
- Locations (1)
Kuopio University Hospital
🇫🇮Kuopio, Northern Savo, Finland