Intervention to Improve Inhalative Adherence

Study Overview
=================
Brief Summary
-----------------
Asthma and chronic obstructive pulmonary disease (COPD) are common lung. Despite the important progresses achieved in treatments, the majority of affected patients suffer from severe symptoms and tend to be frequently hospitalised due to exacerbation. Reasons for uncontrolled asthma and COPD are manifold, but often a poor inhalation technique and a poor following of the prescribed treatment plan is observed, which is called non-adherence. The primary aim of this study will therefore be to measure medication adherence in patients with chronic obstructive lung diseases, and to investigate the impact of an audio reminder on disease outcomes and quality of life. The investigators hypotheses will be that an adherence reminder, improve medication adherence and that a good medication adherence elongate the time to next exacerbation in patients with chronic obstructive lung diseases. A prospective single-blind randomized controlled study is planned, where the investigators are going to analyse the adherence over a period of six months of in- and outpatients, who have experienced at least one exacerbation during the last year. The adherence of intervention- and control group will be measured by specific electronic data capture devices which can save each actuation with date and time. Patients assigned to the intervention group will be reminded for the inhalation by an audio reminder and will receive support calls if medication will not be taken as prescribed or if rescue medication will be used too often. In contrast, the control group, will not be reminded and will not receive any calls, if do not comply with the prescribed medication schedule or if they use their rescue medication too frequently. During study period, participants will be assessed every two months. Each assessment will include spirometry, measurement of diffusion capacity, exhaled nitric oxide and carbon monoxide. Moreover participants will demonstrate their inhalation techniques by using placebo devices and fill out questionnaires regarding quality of life. Statistical significance will be acquired if a p value of less than 0.05 is attained. Time to next exacerbation will be compared using the Kaplan-Meier method and Cox proportional hazard model. Results will be reported as HR (hazard ratio) with corresponding 95% confidence interval (CI) and p-value. Time to next exacerbation is subject to the investigators power calculation. A previous study has shown that 30% of COPD patients are readmitted again within six month because of an exacerbation. The investigators expect that 12% of patients in the intervention group will have an exacerbation. This corresponds to a hazard ratio of 0.36. Assuming a sample size of 70 subjects for each study group, there is a power of 80% to detect a HR of 0.36 based on a one-tailed test. Additional 14 subjects (7 for each study group) have been added to account for drop outs. Therefore, 154 subjects will be investigated in this study.

Official Title
-----------------
Impact of a Pharmaceutical Care Intervention to Improve Adherence of Inhaled Medication in Asthma and COPD Patients

Conditions
-----------------
Chronic Asthma, COPD

Intervention / Treatment
-----------------
* Device: Smartinhaler/POEMS with audio reminders and additional support calls


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In- and outpatients older than 18 years, who have a clinical diagnosis of asthma or COPD At least one exacerbation in the last year Participants need to be able to give informed consent. A good knowledge of the German language by themselves. Patients 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 Criteria: Patients who have other lung diseases than asthma and COPD Subjects with severe diseases (e.g. active carcinoma, major depression) Pregnant or lactating women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Patients assigned to the intervention group will receive a Smartinhaler/POEMS, which will contain an audio reminder function. If the alarm function is on, a ring tone will be generated, after the time predesigned for inhalation. If the use of rescue medication doubles or if the inhaled medication is not inhaled as prescribed for more than two consecutive days, the investigator will call them to see if they need help and to find out the reason for non-adherence. | Device: Smartinhaler/POEMS with audio reminders and additional support calls<br>* Patients assigned to the intervention group will receive a Smartinhaler/POEMS, which will contain an audio reminder function. If the alarm function is on, a ring tone will be generated, after the time predesigned for inhalation. If the use of rescue medication doubles or if the inhaled medication is not inhaled as prescribed for more than two consecutive days, the investigator will call them to see if they need help and to find out the reason for non-adherence.<br>|
| No Intervention: Control group<br>Patients in the control group will receive a Smartinhaler/POEMS, which only records their adherence. The alarm function of the devices will be switched off, and these participants will not be reminded to take their inhalers. This group will not receive any calls, if they do not comply with the prescribed medication schedule or if they use their rescue medication too frequently. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to next asthma or COPD exacerbation | The primary endpoint of this study is the time to next asthma or COPD exacerbation, defined as acute-onset worsening of the patient's condition beyond day-to-day variations requiring interaction with a healthcare provider, which may occur during the index exacerbation or follow-up. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of exacerbation | Number of exacerbation of each patient will be recorded during the study-period | 6 months | 
| adherence | The adherence will be measured with the Smartinhaler and POEMS. Objective adherence will be investigated by analyzing taking adherence, expressed as average percentage [ unit:%] . Timing adherence and number of days without Inhalation (gaps) will be expressed as absolute and relative numbers of day [ unit:days- % and %] . This project focuses on the implementation of a prescribed dosing regimen. | 6 months | 
| Attitude toward medication | With the Beliefs about Medicines Questionnaire (BMQ) patients' attitude towards their medication can be assessed. This questionnaire has been validated for the use in chronic illness patients and consists of two 5-item scales assessing patients' beliefs about the necessity of the prescribed medication and their concerns about the potential adverse consequences of taking it. The scale of this questionnaire ranges from 1(strongly disagree) to 5 (strongly agree). The total score for necessity and concerns range from 5 to 25. | 6 months | 
| Changes in lung function | To measure changes in lung functions, different tests will be done. Spirometry is a test that measures how an individual inhales or exhales volumes of air as a function of time. The measurement of the diffusion capacity of the lung will be used to obtain information regarding pulmonary gas transfer. It has been shown, that the level of exhaled nitric oxide (NO) correlates with airway inflammation. The measurement of exhaled nitric oxide can therefore be used as an indicator of airway inflammation. The smoking status of the participants will be ascertained using expired carbon monoxide. Carbon monoxide (CO) is an invisible odourless gas that is able to displace oxygen in the blood so that the organ cannot be sufficiently provided with oxygen. | 6 months | 
| Evaluation of inhalation techniques | For evaluation of the technique, participants will demonstrate how they usually use their device. Placebo devices will be used for the participants in both groups to prevent them from overdose. For the evaluation of inhaler use, preliminarily defined step-by step checklists for each inhaler will be used. The checklists are based on user guidelines and instruction package inserts from the manufacturers.Inhaler technique will be accepted as correct when every step controlled in the checklist will be performed correctly. | 6 months | 
| Quality of life | Quality of life will be assessed using different questionnaires. The St. George Respiratory Questionnaire is a questionnaire,which was developed for measuring impaired health and perceived well-being in patients with asthma and COPD. The SF-36 is a general quality of life questionnaire consisting of 36 items. It refers to the past four weeks and contains 9 domains concerning vitality, general health perception, physical functioning, social functioning, role limitations, pain, mental health and health change. The COPD Assessment Test (CAT) is a 8-item questionnaire designed to measure the impact of COPD symptoms on health status of patients. The Asthma Control Test (ACT) is a questionnaire that helps to facilitate the assessment of asthma control. ACT includes 5 items assessing frequency of shortness of breath and general asthma symptoms, use of rescue medication, the effect of asthma on daily functioning and overall self assessment of asthma control. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adherence of inhaled medication, pharmaceutical care intervention