Intervention to Improve Inhalative Adherence

NCT ID: NCT02386722

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 169 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2017-04-30

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.

Conditions

Chronic Asthma; COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention group

The intervention consisted of an audio-reminder, generated by an app (in case of SmartInhaler devices) or in form of an alarm clock (for the POEMS), and directly transferred to the participants' smartphones. Patients were allowed to choose the inhalation times themselves. The reminder generated by the by the smartphone had to be quitted by the patients. Patients in the intervention group received support calls carried out by the pharmacist or trained study nurses, when the use of rescue medication doubled or when the medication was not inhaled as prescribed for more than two consecutive days. Participants also received a feedback on their adherence at each clinical visit, especially for the results of the POEMS.

Group Type: EXPERIMENTAL

Electronic Monitoring with audio reminders and additional support

Intervention Type: DEVICE

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).

Control group

Patients in the control group received a Smartinhaler/POEMS, which only records their adherence. Patients assigned to the control group did not receive any reminder or support regarding their adherence to inhaled medication.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Basel

OTHER

Sponsor Role: collaborator

Cantonal Hosptal, Baselland

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Jörg Leuppi

Head University Clinic of Internal Medicine, Canton Hospital Baselland

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jörg Leuppi, Prof.MD PhD

Role: PRINCIPAL_INVESTIGATOR

061 925 21 81

Locations

Cantonal Hospital Baselland Liestal

Liestal, Basel-Landschaft, Switzerland

Cantonal Hospital Baselland

Liestal, Basel-Landschaft, Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 31796013 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29061556 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

269/13

Identifier Type: -

Identifier Source: org_study_id