NCT04246931

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 29, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

2 months

First QC Date

January 15, 2020

Last Update Submit

March 25, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Knowledge and perception of adherence

    Gathering knowledge based on semi-structured interview (definition, causes, consequences of bad adherence,...)

    Baseline

Secondary Outcomes (1)

  • Test of the adherence to inhalers-questionnaire (TAI)

    Baseline

Study Arms (3)

Pulmonologists

Interviews with pulmonologists

Other: No intervention (survey)

General practitioners

Interviews with general practitioners

Other: No intervention (survey)

Patients

Survey with COPD patients

Other: No intervention (survey)

Interventions

No intervention -\> survey at 1 timepoint

General practitionersPatientsPulmonologists

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Pulmonologists, general practicioners and COPD patients

You may qualify if:

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

You may not qualify if:

  • Not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medistrat

Lasne, Belgium

Location

MeSH Terms

Conditions

Treatment Adherence and CompliancePulmonary Disease, Chronic Obstructive

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Sofie Geelissen, PhD

    Chiesi Belgium

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2020

First Posted

January 29, 2020

Study Start

January 1, 2020

Primary Completion

March 15, 2020

Study Completion

June 30, 2020

Last Updated

March 26, 2020

Record last verified: 2020-03

Locations