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

NCT03087188 | Completed

• 1 other identifier: 15-031
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Obstructive Lung Disease; COPD; Asthma

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

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

Interventions

Utilization of inhalator OTHER

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.

Utilization of inhalator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

University Hospital RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

MeSH Terms

Conditions

Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Asthma

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Tobias Müller, PD Dr. med.

  University Hospital, Aachen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: March 22, 2017
• Study Start: September 9, 2015
• Primary Completion: March 15, 2017
• Study Completion: March 15, 2017
• Last Updated: March 22, 2017

Record last verified: 2017-03

Locations

DE (1)