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

This study is currently recruiting participants.
Verified July 2016 by Fondazione Don Carlo Gnocchi Onlus
Sponsor:
ClinicalTrials.gov Identifier:
NCT02499653
First Posted: July 16, 2015
Last Update Posted: April 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Catholic University of the Sacred Heart
Information provided by (Responsible Party):
Fondazione Don Carlo Gnocchi Onlus
  Purpose
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.

Condition Intervention
Pulmonary Disease, Chronic Obstructive Behavioral: Psychological Intervention Behavioral: Videos

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Psychological Intervention to Promote Acceptance and Adherence to Non-Invasive Ventilation (NIV) in People With Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by Fondazione Don Carlo Gnocchi Onlus:

Primary Outcome Measures:
  • Change from baseline in Quality of Life (QoL) in COPD patients at 3, 6 and 12 months as measured by EuroQoL (EQ5D) [ Time Frame: Baseline + After 3, 6 and 12 months following the recruitment ]
    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.


Secondary Outcome Measures:
  • 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) [ Time Frame: Baseline + After 3, 6 and 12 months following the recruitment ]
    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.

  • 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) [ Time Frame: Baseline + After 3, 6 and 12 months following the recruitment ]
    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.


Estimated Enrollment: 150
Study Start Date: June 2015
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Psychological Intervention
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
Active Comparator: Videos
The subjects assigned in the Control Group watch some videos relating to the management of their disease.
Behavioral: Videos

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02499653


Locations
Italy
Paolo Banfi Recruiting
Milan, Italy, 20149
Contact: Paolo Banfi, MD    02-39703341 ext 0039    pabanfi@dongnocchi.it   
Sponsors and Collaborators
Fondazione Don Carlo Gnocchi Onlus
Catholic University of the Sacred Heart
  More Information

Publications:
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.
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fondazione Don Carlo Gnocchi Onlus
ClinicalTrials.gov Identifier: NCT02499653     History of Changes
Other Study ID Numbers: FDG_PSYNIV_COPD01
First Submitted: June 29, 2015
First Posted: July 16, 2015
Last Update Posted: April 19, 2017
Last Verified: July 2016

Keywords provided by Fondazione Don Carlo Gnocchi Onlus:
Chronic Obstructive Pulmonary Disease (COPD)
Non Invasive Ventilation (NIV)
Acceptance
Adherence
Clinical Psychology

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes


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