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

February 5, 2018 updated by: Fondazione Don Carlo Gnocchi Onlus

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20149
        • Recruiting
        • Paolo Banfi
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline + After 3, 6 and 12 months following the recruitment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
Baseline + After 3, 6 and 12 months following the recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Collaborators

Catholic University of the Sacred Heart

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

June 29, 2015

First Submitted That Met QC Criteria

July 14, 2015

First Posted (Estimate)

July 16, 2015

Study Record Updates

Last Update Posted (Actual)

February 6, 2018

Last Update Submitted That Met QC Criteria

February 5, 2018

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDG_PSYNIV_COPD01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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