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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02499653
• Other study ID #: FDG_PSYNIV_COPD01
• Status: Recruiting
• Phase: N/A
• First received: June 29, 2015
• Last updated: February 5, 2018
• Start date: June 2015
• Est. completion date: January 2020

Study information

• Verified date: July 2016
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Psychological Intervention

• Videos

Locations

Country	Name	City	State
Italy	Paolo Banfi	Milan

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus	Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Balestroni G, Bertolotti G. [EuroQol-5D (EQ-5D): an instrument for measuring quality of life]. Monaldi Arch Chest Dis. 2012 Sep;78(3):155-9. Italian. — View Citation

Horne, R., Weinman, J., & Hankins, M. (1999). The beliefs about medicines questionnaire: the development and evaluation of a new method for assessing the cognitive representation of medication. Psychology and health, 14(1), 1-24.

Outcome

Type	Measure	Description	Time frame	Safety issue
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