A Psychological Intervention to Promote Acceptance and Adherence to NIV in People With COPD

Study Overview
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Brief Summary
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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.

Official Title
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A Psychological Intervention to Promote Acceptance and Adherence to Non-Invasive Ventilation (NIV) in People With Chronic Obstructive Pulmonary Disease (COPD)

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Behavioral: Psychological Intervention
* Behavioral: Videos


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychological Intervention<br>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). | Behavioral: Psychological Intervention<br> <br> |
| Active Comparator: Videos<br>The subjects assigned in the Control Group watch some videos relating to the management of their disease. | Behavioral: Videos<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Quality of Life (QoL) in COPD patients at 3, 6 and 12 months as measured by EuroQoL (EQ5D) | 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. | Baseline + After 3, 6 and 12 months following the recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | It will be summarized by weekly means and standard deviations of hours of use of Non Invasive Ventilation (NIV). All subjects will be assigned to this assessment. | Baseline + After 3, 6 and 12 months following the recruitment | 
| 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) | A specific instrument, adapted to detect representations of NIV, it is being validated. It will be based on a modified version of the Beliefs about Medicines Questionnaire (BMQ) developed by Prof. Dr. Rob Horne et al. This tool is used to check the patient's beliefs regarding medications. It consists of two scales: Beliefs Specifications (10 items) and General Beliefs (8 items). In order to achieve the objectives of the study, we will use a modified version of the BMQ, adapted to detect representations of NIV. The unit of measure will be the scale that emerges from the test. All subjects will be assigned to psychometric assessment. | Baseline + After 3, 6 and 12 months following the recruitment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Pulmonary Disease (COPD), Non Invasive Ventilation (NIV), Acceptance, Adherence, Clinical Psychology