Adherence, TreatmentNCT04246931
Adherence Evaluation in COPD
An observational study of Adherence, Treatment and COPD, run by Chiesi SA/NV at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adherence, Treatment, COPD
- How many people
- 260 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2020to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Pulmonologists, general practicioners and COPD patients
Who may be able to join
- Pulmonologists or general practitioners or COPD patient (suffering from COPD treated with inhalation therapy)
Who cannot join
- Not applicable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Adherence, Treatment, COPD
- Being tested
- No intervention (survey)
- Medical subject headings
- Treatment Adherence and Compliance, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (survey)Other
No intervention -> survey at 1 timepoint
| Study group | Role | What they receive |
|---|---|---|
| Pulmonologists | Interviews with pulmonologists Receives: Other: No intervention (survey) | |
| General practitioners | Interviews with general practitioners Receives: Other: No intervention (survey) | |
| Patients | Survey with COPD patients Receives: Other: No intervention (survey) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge and perception of adherence
Gathering knowledge based on semi-structured interview (definition, causes, consequences of bad adherence,...)
Measured: Baseline
Secondary outcomes (1)
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start1 Jan 2020
- Primary completion15 Mar 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adherence, TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiesi SA/NV
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sofie Geelissen, PhD, Study chair, Chiesi Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04246931
- Sponsor's protocol ID
- Chiesi_NIS_0003
- Status last verified
- Mar 2020
- First submitted
- 15 Jan 2020
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Perception and Knowledge of Adherence to COPD Inhalation Therapy at Patient, GP and Pulmonologist Level
- ClinicalTrials.gov ID
- NCT04246931
- Acronym / sponsor ID
- Chiesi_NIS_0003
- Conditions
- Adherence, Treatment, COPD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Chiesi SA/NVUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 15 Mar 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 29 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pulmonologists | – | Other: No intervention (survey)Interviews with pulmonologists |
| General practitioners | – | Other: No intervention (survey)Interviews with general practitioners |
| Patients | – | Other: No intervention (survey)Survey with COPD patients |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Pulmonologists, general practicioners and COPD patients
Key inclusion criteria (1 listed)
- Pulmonologists or general practitioners or COPD patient (suffering from COPD treated with inhalation therapy)
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention (survey)No intervention -> survey at 1 timepoint | Other | General practitioners, Patients, Pulmonologists |
Primary outcome
Knowledge and perception of adherence
Time frame: Baseline
Gathering knowledge based on semi-structured interview (definition, causes, consequences of bad adherence,...)
1 secondary outcome
Test of the adherence to inhalers-questionnaire (TAI)
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sofie Geelissen, PhD study chair
Chiesi Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adherence, Treatment and COPD, run by Chiesi SA/NV at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge and perception of adherence (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.