AsthmaNCT03791658
Assessment of Adherence to Controller Inhalation Medication in Asthma- and COPD Patients.
A study testing The 12-question TAI, Information from patients file and The COPD Assessment Test (CAT) in people with Asthma and COPD, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
The main aim of the study is to evaluate the adherence to controller inhalation medication in asthma and Chronic Obstructive Pulmonary Disease (COPD) in Universitair Ziekenhuis Brussel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, COPD, Adherence, Medication
- What is being tested?
- The 12-question TAI, Information from patients file and The COPD Assessment Test (CAT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Jan 2019to 2 May 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Asthmatics with treatment ≥ GINA step 2.
- COPD-patients , GOLD stage II-IV.
Who cannot join
- No spirometry results available.
- COPD patients not on long-acting bronchodilators.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Universitair Ziekenhuis Brussel
Brussels, Brussels Capital, 1090
About this study
The main aim of the study is to evaluate the adherence to controller inhalation medication in asthma and Chronic Obstructive Pulmonary Disease (COPD) in Universitair Ziekenhuis Brussel. Adherence will be assessed using the 12-question Test for the Adherence to Inhalers (TAI) yielding a score indicating level of adherence (high, intermediate or poor). The TAI also provides some indication about the possible mechanisms of non-adherence (sporadic, deliberate or unconscious). The aim of the study is also to compare the adherence between the 2 study subgroups (asthma and COPD patients). Several other factors which could influence the compliance of the patients will also be evaluated: age, sex, pack years, FEV1 (Forced Expiratory Volume 1), exacerbation history, symptom control, type of inhaler and number of inhalers. By identifying different patient and treatment characteristics that lead to non-adherence, future education efforts could be better targeted to these patients presenting the most important unmet need in terms of adherence.
Read the detailed description
Adherence to the controller inhalation medication is an important component of asthma and COPD care. Good adherence to the prescribed medication is asthma patients is associated with better symptom control and improved lung function. Also, lower exacerbation rate and mortality risk, less healthcare utilisation, lower healthcare-associated costs and a better quality of life are linked with better adherence in asthma and COPD patients.
However, studies have shown that the adherence to therapy in chronically ill patients averages around 50%. In asthma patients the level of adherence varies between 30-70%, while compliance rate in COPD patients is around 20-60% (though the numbers vary). Adherence in asthma and COPD patients is thus generally low.
Adherence in these patients is measured in studies in different ways: electronic device monitoring, dispensing data, drug levels or several self-administered questionnaires, among others. Each technique has its own benefits and drawbacks. However, the easiest to use are the self-administered questionnaires. Although many of these exist, a particularly interesting questionnaire is the TAI (Test for the Adherence to Inhalers). It exists in 2 versions: a 10-question and a longer 12-question test. The 12 question TAI has 2 added questions, in which a healthcare professional evaluates the use of the inhaler by the patient. All 12 questions can then be used to identify different non-compliance behavioural patterns. The advantages of this questionnaire are therefore that it can be used for both asthma and COPD patients, that it is designed specifically for inhalation medication and that it not only measures adherence but also the type of non-compliance .
The main aim of the study is thus to evaluate the adherence to controller inhalation medication in asthma and COPD in Universitair Ziekenhuis Brussel. Adherence will be assessed using the 12-question TAI (Test for the Adherence to Inhalers). The aim of the study is also to compare the adherence between the 2 study subgroups (asthma and COPD patients). Several other factors which could influence the compliance of the patients will also be evaluated: age, sex, pack years, FEV1, exacerbation history, symptom control, type of inhaler and number of inhalers. By identifying different patient and treatment characteristics that lead to non-adherence, future education efforts could be better targeted to these patients presenting the most important unmet need in terms of adherence.
Patient recruitment will take place at the Universitair Ziekenhuis Brussel respiratory outpatient clinic. Before their scheduled appointment, patients they will be screened to participate in the study. Recruitment will start January 2019 until March 2019, or until the target number of patients is reached. On the day of their appointment, the participants will receive all necessary information about the study and the informed consent process from the principal investigator.
Patients will have sufficient time to reflect on their participation in this study and to ask questions. After obtaining the written informed consent from the patients, the necessary interventions (filling in questionnaires and gathering information from the patients files) will take place.
It will be allowed for the patients to provide informed consent and to participate in the study on a later date.
Statistical analysis:
The statistical analysis will be conducted in 3 steps :
- Preliminary one-way ANOVA to evaluate the dependent variable (TAI level of adherence) for each independent variable.
- A multi-way ANOVA model will be constructed to include the relevant independent variables and potential two-way interactions, by maximization of adjusted R2 obtained through a backward elimination in order to correct for multicollinearity.
- In a final step, the model residuals will be checked to satisfy the normality condition through application of the Kolmogorov-Smirnov and Shapiro-Wilk tests, also exploring the influence of potential heteroscedasticity.
- Conditions
- Asthma, COPD, Adherence, Medication
- Being tested
- The 12-question TAI, Information from patients file, The Asthma Control Test (ACT), The COPD Assessment Test (CAT)
- Keywords
- TAI, Test for the Adherence to Inhalers
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The 12-question TAIOther
The 12-question TAI (Test for the Adherence to Inhalers) yields a score indicating level of adherence (high, intermediate or poor). The TAI also provides some indication about the possible mechanisms of non-adherence (sporadic, deliberate or unconscious).
Information from patients fileOther
Depending on which arm or group specific information will be gathered from the patients file after informed consent.
The Asthma Control Test (ACT)Other
An international validated questionnaire on the symptoms an asthmatic experiences and the disease control in the patient. Only for the Asthmatics arm of the study
The COPD Assessment Test (CAT)Other
An international validated questionnaire on the symptoms a COPD-patient experiences and the disease control in the patient. Only for the COPD arm of the study
| Study group | Role | What they receive |
|---|---|---|
| Asthmatics | Other | From the patients file the following information will be collected by the investigators:
* Age
* Sex
* FEV1 derived from the last spirometry (including spirometry performed on day of study visit).
* GINA step (Global Initiative for Asthma).
* Number of exacerbations in the year prior to the study.
* The prescribed medication: type of inhaler, number of inhalers for maintenance treatment, number of inhalations a day.
* Number of different medications taken by the patient on a daily basis, excluding the inhalers for maintenance treatment of asthma.
* FENO (Fraction Exhaled Nitric Oxide) from the day of the study visit (if available).
Patients will fill out:
* The 12-question TAI-questionnaire (test for the adherence to inhalers)
* The Asthma Control Test (ACT) Receives: Other: The 12-question TAI; Other: Information from patients file; Other: The Asthma Control Test (ACT) |
| COPD-patients | Other | From the patients file the following information will be collected by the investigators:
* Age
* Sex
* Pack Years
* GOLD stage (Global Initiative for Chronic Obstructive Lung Disease)(post-bronchodilator FEV1)
* Number of exacerbations in the year prior to the study.
* The prescribed medication: type of inhaler, number of inhalers for maintenance treatment, number of inhalations a day.
* Number of different medications taken by the patient on a daily basis, excluding the inhalers for maintenance treatment of COPD.
Patients will fill out:
* The 12-question TAI-questionnaire (test for the adherence to inhalers)
* The COPD Assessment Test (CAT) Receives: Other: The 12-question TAI; Other: Information from patients file; Other: The COPD Assessment Test (CAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to inhalation medication evaluated using the Test for the Adherence to Inhalers
Level of adherence: high (=50 points), intermediate (between 46 and 49 points) or poor (< or = 45 points) .
Measured: 15 minutes
Secondary outcomes (2)
Type of non-adherence/ Behavioural pattern (using TAI)
Sporadic non-adherence: items 1 to 5 <25points Deliberate non-adherence: items 6 to 10 < 25 points Unconscious non-adherence: items 11 and 12 < 4 points
Measured: 15 minutes
Adherence in correlation to specific factors
Asthma patients: Age, sex, FEV1 derived from the last spirometry (including spirometry performed on day of study visit), GINA step, number of exacerbations in the year prior to the study, the prescribed medication: type of inhaler, number of inhalers for maintenance treatment, number of inhalations a day, number of different medications taken by the patient on a daily basis (excluding the inhalers for maintenance treatment of asthma), FENO from the day of the study visit (if available), result of ACT. COPD-patients: Age, sex, Pack Years, GOLD stage and GOLD group, the prescribed medication: type of inhaler, number of inhalers for maintenance treatment, number of inhalations a day, number of different medications taken by the patient on a daily basis (excluding the inhalers for maintenance treatment of COPD).
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study start2 Jan 2019
- Primary completion17 Apr 2019
- Study completion2 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Cross-sectional, single center, single visit study. 1 group of 70 asthmatics, 1 group of 70 COPD-patients
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Nicky Vancampenhout, Universitair Ziekenhuis Brussel
- Investigators
- Lisa N Vancampenhout, Principal investigator, Master student in Medicine at Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03791658
- Sponsor's protocol ID
- PNE 2018-386
- Status last verified
- May 2019
- First submitted
- 31 Dec 2018
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Choice made with regards to the current General Data Protection Regulation in Europe.
Publications
Plaza V, Fernandez-Rodriguez C, Melero C, Cosio BG, Entrenas LM, de Llano LP, Gutierrez-Pereyra F, Tarragona E, Palomino R, Lopez-Vina A; TAI Study Group. Validation of the 'Test of the Adherence to Inhalers' (TAI) for Asthma and COPD Patients. J Aerosol Med Pulm Drug Deliv. 2016 Apr;29(2):142-52. doi: 10.1089/jamp.2015.1212. Epub 2015 Jul 31.
PubMed 26230150
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Adherence to Controller Inhalation Medication in Asthma- and COPD Patients.
- ClinicalTrials.gov ID
- NCT03791658
- Acronym / sponsor ID
- PNE 2018-386
- Conditions
- Asthma, COPD, Adherence, Medication
- Keywords
- TAI, Test for the Adherence to Inhalers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 17 Apr 2019 (actual)
- Study completion
- 2 May 2019 (actual)
- First posted
- 2 Jan 2019 (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 main aim of the study is to evaluate the adherence to controller inhalation medication in asthma and Chronic Obstructive Pulmonary Disease (COPD) in Universitair Ziekenhuis Brussel. Adherence will be assessed using the 12-question Test for the Adherence to Inhalers (TAI) yielding a score indicating level of adherence (high, intermediate or poor). The TAI also provides some indication about the possible mechanisms of non-adherence (sporadic, deliberate or unconscious). The aim of the study is also to compare the adherence between the 2 study subgroups (asthma and COPD patients). Several other factors which could influence the compliance of the patients will also be evaluated: age, sex, pack years, FEV1 (Forced Expiratory Volume 1), exacerbation history, symptom control, type of inhaler and number of inhalers. By identifying different patient and treatment characteristics that lead to non-adherence, future education efforts could be better targeted to these patients presenting the most important unmet need in terms of adherence.
Detailed description
Adherence to the controller inhalation medication is an important component of asthma and COPD care. Good adherence to the prescribed medication is asthma patients is associated with better symptom control and improved lung function. Also, lower exacerbation rate and mortality risk, less healthcare utilisation, lower healthcare-associated costs and a better quality of life are linked with better adherence in asthma and COPD patients.
However, studies have shown that the adherence to therapy in chronically ill patients averages around 50%. In asthma patients the level of adherence varies between 30-70%, while compliance rate in COPD patients is around 20-60% (though the numbers vary). Adherence in asthma and COPD patients is thus generally low.
Adherence in these patients is measured in studies in different ways: electronic device monitoring, dispensing data, drug levels or several self-administered questionnaires, among others. Each technique has its own benefits and drawbacks. However, the easiest to use are the self-administered questionnaires. Although many of these exist, a particularly interesting questionnaire is the TAI (Test for the Adherence to Inhalers). It exists in 2 versions: a 10-question and a longer 12-question test. The 12 question TAI has 2 added questions, in which a healthcare professional evaluates the use of the inhaler by the patient. All 12 questions can then be used to identify different non-compliance behavioural patterns. The advantages of this questionnaire are therefore that it can be used for both asthma and COPD patients, that it is designed specifically for inhalation medication and that it not only measures adherence but also the type of non-compliance .
The main aim of the study is thus to evaluate the adherence to controller inhalation medication in asthma and COPD in Universitair Ziekenhuis Brussel. Adherence will be assessed using the 12-question TAI (Test for the Adherence to Inhalers). The aim of the study is also to compare the adherence between the 2 study subgroups (asthma and COPD patients). Several other factors which could influence the compliance of the patients will also be evaluated: age, sex, pack years, FEV1, exacerbation history, symptom control, type of inhaler and number of inhalers. By identifying different patient and treatment characteristics that lead to non-adherence, future education efforts could be better targeted to these patients presenting the most important unmet need in terms of adherence.
Patient recruitment will take place at the Universitair Ziekenhuis Brussel respiratory outpatient clinic. Before their scheduled appointment, patients they will be screened to participate in the study. Recruitment will start January 2019 until March 2019, or until the target number of patients is reached. On the day of their appointment, the participants will receive all necessary information about the study and the informed consent process from the principal investigator.
Patients will have sufficient time to reflect on their participation in this study and to ask questions. After obtaining the written informed consent from the patients, the necessary interventions (filling in questionnaires and gathering information from the patients files) will take place.
It will be allowed for the patients to provide informed consent and to participate in the study on a later date.
Statistical analysis:
The statistical analysis will be conducted in 3 steps :
- Preliminary one-way ANOVA to evaluate the dependent variable (TAI level of adherence) for each independent variable.
- A multi-way ANOVA model will be constructed to include the relevant independent variables and potential two-way interactions, by maximization of adjusted R2 obtained through a backward elimination in order to correct for multicollinearity.
- In a final step, the model residuals will be checked to satisfy the normality condition through application of the Kolmogorov-Smirnov and Shapiro-Wilk tests, also exploring the influence of potential heteroscedasticity.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cross-sectional, single center, single visit study. 1 group of 70 asthmatics, 1 group of 70 COPD-patients
| Arm | Type | Receives |
|---|---|---|
| Asthmatics | Other | Other: The 12-question TAI, Other: Information from patients file, Other: The Asthma Control Test (ACT)From the patients file the following information will be collected by the investigators: * Age * Sex * FEV1 derived from the last spirometry (including spirometry performed on day of study visit). * GINA step (Global Initiative for Asthma). * Number of exacerbations in the year prior to the study. * The prescribed medication: type of inhaler, number of inhalers for maintenance treatment, number of inhalations a day. * Number of different medications taken by the patient on a daily basis, excluding the inhalers for maintenance treatment of asthma. * FENO (Fraction Exhaled Nitric Oxide) from the day of the study visit (if available). Patients will fill out: * The 12-question TAI-questionnaire (test for the adherence to inhalers) * The Asthma Control Test (ACT) |
| COPD-patients | Other | Other: The 12-question TAI, Other: Information from patients file, Other: The COPD Assessment Test (CAT)From the patients file the following information will be collected by the investigators: * Age * Sex * Pack Years * GOLD stage (Global Initiative for Chronic Obstructive Lung Disease)(post-bronchodilator FEV1) * Number of exacerbations in the year prior to the study. * The prescribed medication: type of inhaler, number of inhalers for maintenance treatment, number of inhalations a day. * Number of different medications taken by the patient on a daily basis, excluding the inhalers for maintenance treatment of COPD. Patients will fill out: * The 12-question TAI-questionnaire (test for the adherence to inhalers) * The COPD Assessment Test (CAT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Asthmatics with treatment ≥ GINA step 2.
- COPD-patients , GOLD stage II-IV.
Key exclusion criteria (2 listed)
- No spirometry results available.
- COPD patients not on long-acting bronchodilators.
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 |
|---|---|---|
| The 12-question TAIThe 12-question TAI (Test for the Adherence to Inhalers) yields a score indicating level of adherence (high, intermediate or poor). The TAI also provides some indication about the possible mechanisms of non-adherence (sporadic, deliberate or unconscious). | Other | Asthmatics, COPD-patients |
| Information from patients fileDepending on which arm or group specific information will be gathered from the patients file after informed consent. | Other | Asthmatics, COPD-patients |
| The Asthma Control Test (ACT)An international validated questionnaire on the symptoms an asthmatic experiences and the disease control in the patient. Only for the Asthmatics arm of the study | Other | Asthmatics |
| The COPD Assessment Test (CAT)An international validated questionnaire on the symptoms a COPD-patient experiences and the disease control in the patient. Only for the COPD arm of the study | Other | COPD-patients |
Primary outcome
Adherence to inhalation medication evaluated using the Test for the Adherence to Inhalers
Time frame: 15 minutes
Level of adherence: high (=50 points), intermediate (between 46 and 49 points) or poor (< or = 45 points) .
2 secondary outcomes
Type of non-adherence/ Behavioural pattern (using TAI)
Time frame: 15 minutes
Adherence in correlation to specific factors
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
- Background: PubMed 26230150Plaza V, Fernandez-Rodriguez C, Melero C, Cosio BG, Entrenas LM, de Llano LP, Gutierrez-Pereyra F, Tarragona E, Palomino R, Lopez-Vina A; TAI Study Group. Validation of the 'Test of the Adherence to Inhalers' (TAI) for Asthma and COPD Patients. J Aerosol Med Pulm Drug Deliv. 2016 Apr;29(2):142-52. doi: 10.1089/jamp.2015.1212. Epub 2015 Jul 31.
- The Asthma Control Test used in this studyLink provided by the sponsor.
- The COPD Assessment Test used in this studyLink provided by the sponsor.
- Individual participant dataSharing planned: No. Choice made with regards to the current General Data Protection Regulation in Europe.
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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.
Lisa N Vancampenhout principal investigator
Master student in Medicine at Vrije Universiteit Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The 12-question TAI, Information from patients file and The COPD Assessment Test (CAT) in people with Asthma and COPD, run by Universitair Ziekenhuis Brussel 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 29 May 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adherence to inhalation medication evaluated using the Test for the Adherence to Inhalers (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03791658, which also lists 1 linked publication.
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 29 May 2019.