Clinical trial NCT02386722: Intervention to Improve Inhalative Adherence
Official title: Impact of a Pharmaceutical Care Intervention to Improve Adherence of Inhaled Medication in Asthma and COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Asthma
COPD
Keywords: Adherence of inhaled medication
pharmaceutical intervention
Lead sponsor: Cantonal Hosptal, Baselland
Sponsor class: OTHER
Collaborators: name: University of Basel
First posted: 2015-03-12
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Despite progress in pharmacological and non-pharmacological treatment in recent years, the burden of disease among asthma and COPD patients is high and patients may be frequently hospitalized due to exacerbations. Reasons for uncontrolled disease are manifold, but are frequently associated with poor inhalation technique and non-adherence to the prescribed treatment plan which may cause substantial mortality, morbidity, and cost to the healthcare system. In this respect, the study of causes for non-adherence and the development of measures to increase respectively maintain treatment adherence, particularly in chronic diseases, is of major clinical importance.

The aim of this study was to investigate the impact of an acoustic reminder and a close supervision on adherence to inhaled medication and on course of disease and quality of life (Qol) in asthma and COPD patients.

In this single-blinded trial, asthma and/or COPD patients were randomly assigned either to the intervention or the control group. Adherence to inhaled medication was monitored using electronic data capture devices, recording date and time of each inhalation device actuation. Follow-up was six months. Primary outcome was defined as "time to next exacerbation". Secondary outcomes included number of exacerbations, number of exacerbations with hospitalization, taking/timing adherence, and Qol during follow-up. Adherence was measured using electronic data capture devices which saved date and time of each inhalative device actuation. Patients are randomly assigned to an intervention, respectively control group. Patients assigned to the intervention group will receive audio reminder and support calls in case medication is not been taken as prescribed or if rescue medication is used more frequently than prespecified in the study protocol. During the study, participants are assessed every two months.


Eligibility criteria: Inclusion:

* Aged 18 years or older
* Have an established asthma-diagnosis according to the Global Initiative for Asthma (GINA) guidelines and/or
* Have an established COPD diagnosis according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (severity GOLD I-IV based on the international GOLD-Criteria) \[46\] and
* Are prescribed daily inhaled medication (controller medication for a daily maintenance treatment)
* Had at least one exacerbation in the previous 12 months before study start
* With a metered dose Inhaler (e.g. Ventolin®), Diskus (e.g.Seretide®), Turbohaler (e.g.Symbicort®), Aerolizer/Breezhaler (e.g.Onbrez®), HandiHaler (e.g. Spiriva®) or Ellipta (e.g Relvar®)

Exclusion:

* Suffering from malignancies and/or other severe diseases
* Insufficient in the German language
* Pregnant or lactating

Primary outcomes:
measure: Time to Next Asthma or COPD Exacerbation up to 182 Days
timeFrame: 182 days
Secondary outcomes:
measure: Number of Exacerbations.
timeFrame: 180 days
measure: Number of Severe Exacerbations.
timeFrame: 180 days
measure: Adherence to Puff Inhalers
timeFrame: 180 days
measure: Percentage of Days With Adherence to Dry Powder Capsules (Breezhaler and Handihaler) Assessed by POEMS
timeFrame: 180 days
measure: Percentage of Days of Adherence
timeFrame: 180 days
measure: Percentage of Days With Timing Adherence
timeFrame: 180 days
measure: Percentage of Gaps in Puff Inhaler Use
timeFrame: 180 days
measure: Percentage of Gaps for Dry Powder Capsules (Breezhaler, Handihaler), Assessed by POEMS.
timeFrame: 180 days
measure: Numbers of Days of the Longest Period of Time Without Inhalation During the Investigated Time Period
timeFrame: 180 days
measure: Number of Days of the Longest Period of Time Without Inhalation.
timeFrame: 180 days
measure: Score of the St. George Respiratory Questionnaire
timeFrame: 180 days
Other outcomes:
Locations:
city: Liestal
country: Switzerland
facility: Cantonal Hospital Baselland
state: Baselland
city: Liestal
country: Switzerland
facility: Cantonal Hospital Baselland Liestal
state: BL
Study officials:
affiliation: 061 925 21 81
name: Jörg Leuppi, Prof.MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gregoriano C, Dieterle T, Breitenstein AL, Durr S, Baum A, Giezendanner S, Maier S, Leuppi-Taegtmeyer A, Arnet I, Hersberger KE, Leuppi JD. Does a tailored intervention to promote adherence in patients with chronic lung disease affect exacerbations? A randomized controlled trial. Respir Res. 2019 Dec 3;20(1):273. doi: 10.1186/s12931-019-1219-3.
citation: Gregoriano C, Dieterle T, Durr S, Arnet I, Hersberger KE, Leuppi JD. Impact of an Electronic Monitoring Intervention to Improve Adherence to Inhaled Medication in Patients with Asthma and Chronic Obstructive Pulmonary Disease: Study Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2017 Oct 23;6(10):e204. doi: 10.2196/resprot.7522.