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

Fondazione Don Carlo Gnocchi ETS150 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

150

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Psychological InterventionBEHAVIORAL

VideosBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Paolo Banfi

Milan, Italy

RECRUITING

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)

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.

Time frame: Baseline + After 3, 6 and 12 months following the recruitment

Secondary Outcomes

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.

Time frame: 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.

Time frame: Baseline + After 3, 6 and 12 months following the recruitment

Data from ClinicalTrials.gov

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