Have you or your loved ones been diagnosed with chronic obstructive pulmonary disease?

You may be eligible to participate in a chronic obstructive pulmonary disease clinical trial.

Have you or your loved ones been diagnosed with chronic obstructive pulmonary disease? You may be eligible to participate in a chronic obstructive pulmonary disease clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Chronic Obstructive Pulmonary Disease Clinical Trial in Milan

NCT02499653 | Interventional

Have you or your loved ones been diagnosed with chronic obstructive pulmonary disease?

You may be eligible to participate in a chronic obstructive pulmonary disease clinical trial.

Have you or your loved ones been diagnosed with chronic obstructive pulmonary disease? You may be eligible to participate in a chronic obstructive pulmonary disease clinical trial.

Recruiting

Male & Female

18 Years +

This study is looking to recruit 150 Participants

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.

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Details for the study

Brief Title

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

Official Title

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

Brief Summary

This study aims to analyze the impact of a brief psychological support intervention in the<br /> promotion of the adherence to Non Invasive Ventilation (NIV) among people with Chronic<br /> Obstructive Pulmonary Disease (COPD). The investigators expect to see a positive impact of<br /> this intervention on both physical and psychological well-being, and consequently, a<br /> reduction of health costs.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

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

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

Secondary

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

Study Criteria

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