Intervention to Improve Inhalative Adherence

NCT02386722 | Completed Results

• 1 other identifier: 269/13
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 2

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

Keywords

Adherence of inhaled medication; pharmaceutical intervention

Outcome Measures

Primary Outcomes (1)

• Time to Next Asthma or COPD Exacerbation up to 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".

  182 days

Secondary Outcomes (11)

• Number of Exacerbations.

  180 days

• Number of Severe Exacerbations.

  180 days

• Adherence to Puff Inhalers

  180 days

• Percentage of Days With Adherence to Dry Powder Capsules (Breezhaler and Handihaler) Assessed by POEMS

  180 days

• Percentage of Days of Adherence

  180 days

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Device: Electronic Monitoring with audio reminders and additional support

Control group

NO INTERVENTION

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.

Interventions

Electronic Monitoring with audio reminders and additional support 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).

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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®)

You may not qualify if:

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

Sponsors & Collaborators

• Cantonal Hosptal, Baselland: lead
• University of Basel: collaborator

Study Sites (2)

Cantonal Hospital Baselland Liestal

Liestal, Basel-Landschaft, 4410, Switzerland

Location

Cantonal Hospital Baselland

Liestal, Basel-Landschaft, 4410, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 31796013 DERIVED

• 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.

  PMID: 29061556 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Claudia Gregoriano
• Organization: Cantonal Hospital Baselland

claudia.gregoriano@ksbl.ch

+41619253765

Study Officials

• Jörg Leuppi, Prof.MD PhD

  061 925 21 81

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head University Clinic of Internal Medicine, Canton Hospital Baselland

Study Record Dates

• First Submitted: February 14, 2014
• First Posted: March 12, 2015
• Study Start: January 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: March 4, 2025
• Results First Posted: March 4, 2025

Record last verified: 2025-02

Locations

CH (2)