Adherence Evaluation in COPD | NCT04246931

Studies
Adherence Evaluation in COPD

NCT04246931

Sponsor

Chiesi SA/NV

Status

Unknown status

Last Update Posted

Mar 26, 2020Actual

Enrollment

260Estimated

Phase

Not provided

Conditions

Adherence, Treatment
COPD

Interventions

No intervention (survey)

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Mar 15, 2020Estimated

Completion Date

Jun 30, 2020Estimated

First Submitted Date

Jan 15, 2020

First Submission Date that Met QC Criteria

Jan 28, 2020

First Posted Date

Jan 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2020

Last Update Posted Date

Mar 26, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

260Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
No intervention (survey)	Other	No intervention -> survey at 1 timepoint	General practitioners Patients Pulmonologists

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Not applicable

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Pulmonologists, general practicioners and COPD patients

Sampling Method

Probability Sample

Name	Affiliation	Role
Sofie Geelissen, PhD	Chiesi Belgium	Study Chair

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000074822	Treatment Adherence and Compliance
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D015438	Health Behavior
D001519	Behavior
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided