Inhalation Therapy in Ambulant and Hospitalized Patient Using Available Film Sequences From the Internet (InhaliPAD)

There are different therapy strategies for patients suffering on obstructive lung disease like chronic obstructive pulmonary disease (COPD), and asthma bronchial available. One of these strategies includes inhalative drugs, e.g. ß2-mimetics, anticholinergic drugs, or glucocorticoids, which are indicated often and which can be used with different inhalation devices. Dry powder inhalators, and dosieraerosol are used the most in clinical routine. Further strategies in treating obstructive lung disease are innovative systems like Respimat or systems with liquid inhalation. However, the success of the therapy depends on the correct application technique. In the clinical routine a high error rate was observed. Consequently, the initiative of the German league of respiratory tracts published internet-based film sequences in order to demonstrate how to use an inhalator correctly. These films are available in the internet for everyone and can be watched as often as needed in order to improve technique and facilitate training.

Therefore, in this study we aim to evaluate the following aspects:

• amount of wrong applications in ambulant and hospitalized patients (wrong in terms of lack of knowledge on how to use the inhalator or incorrect utilization)
• amount of correct applications in patients who had first used the inhalator incorrectly but improved technique by watching the film sequences
• evaluation of learning success within 2 weeks to 2 months (follow-up visit in the ambulance)

Study Overview

• Status: Completed
• Conditions: Asthma; COPD; Obstructive Lung Disease
• Intervention / Treatment: Other: Utilization of inhalator

• Study Type: Observational
• Enrollment (Actual): 114

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Aachen, NRW, Germany, 52074
      • University Hospital RWTH Aachen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients in need of inhalative therapy due to obstructive lung disease, COPD, or asthma bronchial

Description

Inclusion Criteria:

• male and female patients indicated for inhalative treatment with ß2-mimetics, inhalative steroids, anticholinergic drugs, or a combination of these drugs
• patient was already trained on how to use the inhalator before participating in the study
• age > 18
• obtained written consent

Exclusion Criteria:

• patients who are incapable to consent or are unable to understand the scope of the trial
• patients who indicate that they do not know how to use the inhalator

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Utilization of inhalator; Film sequences will be shown to patients using incorrect application technique in order to improve technique. Learning success will be assessed subsequently and at a follow-up visit after 2-8 weeks

Other: Utilization of inhalator; After written consent patients will be asked whether they know how to use the inhalator and for how long therapy has been already conducted. Patients using the inhalator correctly have completed the study at this point. If patients have demonstrated incorrect use of the inhalator, a film sequence with instructions will be shown via a tablet. The learning success will be assessed subsequently. When patients show correct application, they will be asked to come back for a follow-up visit within 2 to 8 weeks, otherwise they will be retrained by study staff. At the follow-up visit another demonstration evaluation will be performed. While demonstrating patients will use the inhalator without any drug that could have any medicinal effect on them.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correct utilization of inhalator	Wrong utilization is determined as lack of knowledge on how to use the inhalator or incorrect application	Day of Screening and follow-up visit (2-8 weeks)

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Investigators: Principal Investigator: Tobias Müller, PD Dr. med., University Hospital RWTH Aachen

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2015
• Primary Completion (Actual): March 15, 2017
• Study Completion (Actual): March 15, 2017

Study Registration Dates

• First Submitted: March 15, 2017
• First Submitted That Met QC Criteria: March 15, 2017
• First Posted (Actual): March 22, 2017

Study Record Updates

• Last Update Posted (Actual): March 22, 2017
• Last Update Submitted That Met QC Criteria: March 15, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive
• Other Study ID Numbers: 15-031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No