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

NCT02499653 | Unknown

• 1 other identifier: FDG_PSYNIV_COPD01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Chronic Obstructive Pulmonary Disease (COPD); Non Invasive Ventilation (NIV); Acceptance; Adherence; Clinical Psychology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

  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)

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

Study Arms (2)

Psychological Intervention

EXPERIMENTAL

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

Videos

ACTIVE COMPARATOR

The subjects assigned in the Control Group watch some videos relating to the management of their disease.

Behavioral: Videos

Interventions

Psychological Intervention BEHAVIORAL

Psychological Intervention

Videos BEHAVIORAL

Videos

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• refusal of the Informant Consent
• pregnancy
• subjects affected by oncological or psychiatric illnesses
• immune depressive condition as the principal condition
• usage of antidepressant drugs

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Catholic University of the Sacred Heart: collaborator

Study Sites (1)

Paolo Banfi

Milan, 20149, Italy

RECRUITING

Related Publications (4)

• 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.

  PMID: 23614330 BACKGROUND

• 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.

  RESULT

• 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.

  PMID: 35149638 DERIVED

• 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.

  PMID: 28166828 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Psychosocial Intervention; Videotape Recording

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: July 16, 2015
• Study Start: June 1, 2015
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: February 6, 2018

Record last verified: 2016-07

Locations

IT (1)