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Trial record 58 of 661 for:    applied AND web-

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03087188
Recruitment Status : Completed
First Posted : March 22, 2017
Last Update Posted : March 22, 2017
Information provided by (Responsible Party):
RWTH Aachen University

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)

Condition or disease Intervention/treatment
Obstructive Lung Disease COPD Asthma Other: Utilization of inhalator

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Study Type : Observational
Actual Enrollment : 114 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Inhalation Therapy in Ambulant and Hospitalized Patient Using Available Film Sequences From the Internet
Actual Study Start Date : September 9, 2015
Actual Primary Completion Date : March 15, 2017
Actual Study Completion Date : March 15, 2017

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.

Primary Outcome Measures :
  1. Correct utilization of inhalator [ Time Frame: Day of Screening and follow-up visit (2-8 weeks) ]
    Wrong utilization is determined as lack of knowledge on how to use the inhalator or incorrect application

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03087188

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University Hospital RWTH Aachen
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
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Principal Investigator: Tobias Müller, PD Dr. med. University Hospital RWTH Aachen

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Responsible Party: RWTH Aachen University Identifier: NCT03087188     History of Changes
Other Study ID Numbers: 15-031
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases