A Psychological Intervention to Promote Acceptance and Adherence to Non-Invasive Ventilation (NIV) in People With Chronic Obstructive Pulmonary Disease (COPD)
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Change from baseline in Quality of Life (QoL) in COPD patients at 3, 6 and 12 months as measured by EuroQoL (EQ5D)
Study Overview
Brief Summary
This study aims to analyze the impact of a brief psychological support intervention in the promotion of the adherence to Non Invasive Ventilation (NIV) among people with Chronic Obstructive Pulmonary Disease (COPD). The investigators expect to see a positive impact of this intervention on both physical and psychological well-being, and consequently, a reduction of health costs.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age> or =18 years
- •the voluntary participation to the Study
- •inpatients or outpatients
- •subjects with Chronic Obstructive Pulmonary Disease (COPD), from moderate (GOLD 2- 50% ≤ FEV1 <80% pred.) to severe (GOLD 3- 30% ≤ FEV1 <50%pred.) (FEV1= Forced Expiratory Volume in the 1st Second)
Exclusion Criteria
- •refusal of the Informant Consent
- •pregnancy
- •subjects affected by oncological or psychiatric illnesses
- •immune depressive condition as the principal condition
- •usage of antidepressant drugs
Arms & Interventions
Videos
The subjects assigned in the Control Group watch some videos relating to the management of their disease.
Intervention: Videos (Behavioral)
Psychological Intervention
In addition to the standard care, subjects are participating in a brief psychological support, which will include elements of psychological well-being's promotion and cognitive restructuring exercises (mindfulness).
Intervention: Psychological Intervention (Behavioral)
Outcomes
Primary Outcomes
Change from baseline in Quality of Life (QoL) in COPD patients at 3, 6 and 12 months as measured by EuroQoL (EQ5D)
Time Frame: Baseline + After 3, 6 and 12 months following the recruitment
EuroQoL or EQ5D, a simple and short questionnaire consists of two distinct sections: the first in which there are five items (mobility, self-care, usual activities, pain / discomfort, anxiety / depression), concerning the status of health of the subject, which is required to indicate the severity level; the second section includes a visual-analogue scale instead represented graphically as a thermometer graduated from 0 (worst possible health status) to 100 (best possible health state), on which the respondent must indicate the level of perceived health at the time. All subjects will be assigned to psychometric assessment.
Secondary Outcomes
- Change from baseline in adherence NIV in COPD patients at 3, 6 and 12 months as measured by a modified version of the Beliefs About Medicine Questionnaire (BMQ)(Baseline + After 3, 6 and 12 months following the recruitment)
- Change from baseline in acceptance NIV in COPD patients at 3, 6 and 12 months as measured by weekly means and standard deviations of hours of use of Non Invasive Ventilation (NIV)(Baseline + After 3, 6 and 12 months following the recruitment)