Intervention to Improve Inhalative Adherence

Not Applicable

Completed

Conditions: Chronic Asthma
COPD

Interventions: Device: Smartinhaler/POEMS with audio reminders and additional support calls

Registration Number: NCT02386722

Lead Sponsor: Cantonal Hosptal, Baselland

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 169

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Smartinhaler/POEMS with audio reminders and additional support calls	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.

Primary Outcome Measures

Name	Time	Method
Time to Next Asthma or COPD Exacerbation up to 182 Days	182 days	The primary outcome of this study was "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. It was expressed as the number of exacerbations since the last visit with the exact period of exacerbation also including the number of exacerbations requiring hospitalisation. The first exacerbations during the study period served as reference to calculate the primary endpoint "time to next exacerbation".

Secondary Outcome Measures

Name	Time	Method
Percentage of Gaps for Dry Powder Capsules (Breezhaler, Handihaler), Assessed by POEMS.	180 days	Percentage of Gaps = \[number of days without inhalation during the whole study period / number of days in same time period\]
Numbers of Days of the Longest Period of Time Without Inhalation During the Investigated Time Period	180 days	Maximal gap length = number of consecutive days of the longest period of time without Inhalation during the investigated timeperiod.Assessed by Smartinhalers.
Number of Days of the Longest Period of Time Without Inhalation.	180 days	Maximal gap length for dry powder capsules (Breezhaler, Handihaler), Assessed by POEMS = number of consecutive days of the longest period of time without inhalation.
Score of the St. George Respiratory Questionnaire	180 days	Score of the St. George Respiratory Questionnaire. Quality of life was assessed using the St. George Respiratory Questionnaire. This is a questionnaire, which was developed for measuring impaired health and perceived well-being in patients with asthma and COPD. Each Subscore ranges from 0-100, higher scores indicate more limitations in one of the 4 domains. Subscore Symptoms (ranges from 0-100): higher scores indicate worse outcome Subscore Activity (ranges from 0-100): higher scores indicate worse outcome Subscore Impact (ranges from 0-100): higher scores indicate worse outcome Total Score (ranges from 0-100): higher scores indicate worse outcome. The total score is calculated as a weighted sum of the three subscores. Each questionnaire response has a unique empirically derived 'weight'. The lowest possible weight is zero and the highest is 100.
Percentage of Days of Adherence	180 days	percentage of days of Adherence for puff inhalers (metered dose inhalers, Turbohaler, Discus, Ellipta) assessed by Smartinhalers.
Percentage of Days With Timing Adherence	180 days	percentage of days with timing Adherence for dry powder capsules (Breezhaler, Handihaler), assessed by POEMS
Percentage of Gaps in Puff Inhaler Use	180 days	Percentage of Gaps in Puff Inhaler Use Gaps = \[number of days without inhalation during the whole study period / number of days in same time period\] x 100.
Number of Exacerbations.	180 days	Number of exacerbations during the study period.
Number of Severe Exacerbations.	180 days	Exacerbations with the need for hospitalization.
Adherence to Puff Inhalers	180 days	Mean duration with Adherence to Puff Inhalers in the Target Range
Percentage of Days With Adherence to Dry Powder Capsules (Breezhaler and Handihaler) Assessed by POEMS	180 days	percentage of days with Adherence to Dry Powder Capsules. Taking adherence = \[number of puffs inhaled during 24 hours / number of puffs prescribed during 24 hours) x 100. Correct taking adherence was considered when taking adherence was between 80-100%, based on previous studies.