Pulmonary Disease Requiring Ambulatory Oxygen Therapy -Resilience and Quality of Life (koti-happi)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pulmonary Disease
• Intervention / Treatment: Drug: Oxygen gas

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 Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• Finland
  • Northern Savo
    • Kuopio, Northern Savo, Finland, 70029
      • Kuopio University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with pulmonary disease who start or use ambulatory oxygen therapy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pulmonary disease patients; Patients with COPD or other pulmonary disease starting to use ambulatory oxygen therapy	Drug: Oxygen gas; Oxygen administered to a patient using ambulatory oxygen; Other Names: ambulatory oxygen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kuopio University Hospital
• Collaborators: Helsinki University Central Hospital; Tampere University Hospital
• Investigators: Principal Investigator: Merja Kokki, V, Kuopio University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): July 29, 2022
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: September 17, 2020
• First Posted (Actual): September 18, 2020

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: quality of life; lung diseases; resilience; psychological; oxygen inhalation therapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: 507A023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No