Clinical trial NCT02499653: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic Obstructive Pulmonary Disease (COPD)
Non Invasive Ventilation (NIV)
Acceptance
Adherence
Clinical Psychology
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: Catholic University of the Sacred Heart
First posted: 2015-07-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change from baseline in Quality of Life (QoL) in COPD patients at 3, 6 and 12 months as measured by EuroQoL (EQ5D)
timeFrame: Baseline + After 3, 6 and 12 months following the recruitment
Secondary outcomes:
measure: 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)
timeFrame: Baseline + After 3, 6 and 12 months following the recruitment
measure: 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)
timeFrame: Baseline + After 3, 6 and 12 months following the recruitment
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Paolo Banfi
Study officials:
References:
citation: 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. doi: 10.4081/monaldi.2012.121. Italian.
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.
citation: Volpato E, Banfi P, Pagnini F. Promoting Acceptance and Adherence to Noninvasive Ventilation in Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial. Psychosom Med. 2022 May 1;84(4):488-504. doi: 10.1097/PSY.0000000000001053. Epub 2022 Feb 10.
citation: Volpato E, Banfi P, Pagnini F. A psychological intervention to promote acceptance and adherence to non-invasive ventilation in people with chronic obstructive pulmonary disease: study protocol of a randomised controlled trial. Trials. 2017 Feb 6;18(1):59. doi: 10.1186/s13063-017-1802-1.