NCT02386722

Intervention to Improve Inhalative Adherence

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: Cantonal Hosptal, Baselland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Asthma
• COPD

Interventions

Type	Name	Description
DEVICE	Electronic Monitoring with audio reminders and additional support	Automated reminder: -Daily audio-reminder, generated by a smartphone. Support calls (only patients with Smartinhaler): * When the use of rescue medication doubles. * When inhaled medication was not inhaled as prescribed for more than two consecutive days. Feedback on adherence (only patients with POEMS): -At every clinical visit (after 2, 4 and 6 months).

Timeline

• Start date: 2014-01-01
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2015-03-12
• Last updated: 2025-03-04
• Results posted: 2025-03-04

Locations

2 sites across 1 country: Switzerland