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Assessment of Adherence to Controller Inhalation Medication in Asthma- and COPD Patients.

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ClinicalTrials.gov Identifier: NCT03791658
Recruitment Status : Recruiting
First Posted : January 1, 2019
Last Update Posted : January 21, 2019
Sponsor:
Information provided by (Responsible Party):
Lisa Nicky Vancampenhout, Universitair Ziekenhuis Brussel

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Asthma COPD Adherence, Medication Other: The 12-question TAI Other: Information from patients file Other: The Asthma Control Test (ACT) Other: The COPD Assessment Test (CAT) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Cross-sectional, single center, single visit study.

1 group of 70 asthmatics, 1 group of 70 COPD-patients

Masking: None (Open Label)
Primary Purpose: Other
Official Title: Assessment of Adherence to Controller Inhalation Medication in Asthma- and COPD Patients.
Actual Study Start Date : January 2, 2019
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Asthmatics

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)
Other: The 12-question TAI
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).

Other: Information from patients file
Depending on which arm or group specific information will be gathered from the patients file after informed consent.

Other: 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

COPD-patients

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)
Other: The 12-question TAI
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).

Other: Information from patients file
Depending on which arm or group specific information will be gathered from the patients file after informed consent.

Other: 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




Primary Outcome Measures :
  1. 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) .


Secondary Outcome Measures :
  1. Type of non-adherence/ Behavioural pattern (using TAI) [ Time Frame: 15 minutes ]
    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

  2. Adherence in correlation to specific factors [ Time Frame: 15 minutes ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Asthmatics with treatment ≥ GINA step 2.
  • COPD-patients , GOLD stage II-IV.

Exclusion Criteria:

  • No spirometry results available.
  • COPD patients not on long-acting bronchodilators.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03791658


Contacts
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Contact: Lisa N Vancampenhout +32 494929432 Lisa.Nicky.Vancampenhout@vub.be
Contact: Shane Hanon +32 2 477 68 41 shane.hanon@uzbrussel.be

Locations
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Belgium
Universitair Ziekenhuis Brussel Recruiting
Brussel, Brussels, Belgium, 1090
Contact: Lisa Vancampenhout    +32 4 94 92 94 32    Lisa.Nicky.Vancampenhout@vub.be   
Contact: Shane Hanon    +32 2 477 68 41    shane.hanon@uzbrussel.be   
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
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Principal Investigator: Lisa N Vancampenhout Master student in Medicine at Vrije Universiteit Brussel

Additional Information:
Publications:
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Responsible Party: Lisa Nicky Vancampenhout, Medical student, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT03791658     History of Changes
Other Study ID Numbers: PNE 2018-386
First Posted: January 1, 2019    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Choice made with regards to the current General Data Protection Regulation in Europe.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lisa Nicky Vancampenhout, Universitair Ziekenhuis Brussel:
TAI
Test for the Adherence to Inhalers

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases