Adherence Evaluation in COPD

March 25, 2020 updated by: Chiesi SA/NV

Evaluation of Perception and Knowledge of Adherence to COPD Inhalation Therapy at Patient, GP and Pulmonologist Level

The rationale of this study is to have a better understanding of the perception of the pulmonologists, general practitioners and patients of adherence (causes, main consequences, supportive tools,..) and the use of TAI-questionnaire (appreciation, usability,…) by interviewing pulmonologists & general practitioners and a survey with patients. Based on the outcome, projects and tools can be developed to help health care professionals to motivate patients to improve adherence and to help patients to increase their adherence to inhalation therapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

260

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

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Pulmonologists, general practicioners and COPD patients

Description

Inclusion Criteria:

Pulmonologists or general practitioners or COPD patient (suffering from COPD treated with inhalation therapy)

Exclusion Criteria:

Not applicable

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pulmonologists
Interviews with pulmonologists
Other: No intervention (survey)
No intervention -> survey at 1 timepoint
General practitioners
Interviews with general practitioners
Other: No intervention (survey)
No intervention -> survey at 1 timepoint
Patients
Survey with COPD patients
Other: No intervention (survey)
No intervention -> survey at 1 timepoint

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge and perception of adherence
Time Frame: Baseline
Gathering knowledge based on semi-structured interview (definition, causes, consequences of bad adherence,...)
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test of the adherence to inhalers-questionnaire (TAI)
Time Frame: Baseline
Evaluate the usability of 'Test of the adherence to inhalers'-questionnaire (TAI) based on semi-structured interview
Baseline

Collaborators and Investigators

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

Sponsor

Chiesi SA/NV

Investigators

  • Study Chair: Sofie Geelissen, PhD, Chiesi Belgium

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 (Actual)

January 1, 2020

Primary Completion (Anticipated)

March 15, 2020

Study Completion (Anticipated)

June 30, 2020

Study Registration Dates

First Submitted

January 15, 2020

First Submitted That Met QC Criteria

January 28, 2020

First Posted (Actual)

January 29, 2020

Study Record Updates

Last Update Posted (Actual)

March 26, 2020

Last Update Submitted That Met QC Criteria

March 25, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • Chiesi_NIS_0003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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