Effects of the Kata® Inhalations-App on Inhaler Handling Errors, Adherence, and Asthma Control in Patients With Asthma.

NCT06178341 | Completed

• 1 other identifier: Asthma-KaRe
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 13

Brief Summary

The Kata® App is a digital therapy assistant for patients with asthma who need to inhale their therapy. Kata features inhalation trainers that shows patients in a simple and understandable way how to improve their inhalation maneuver so that the drug reaches the lungs efficiently. The Kata® App aims to reduce inhalation errors and ensures that inhaled drugs are used as approved and prescribed. Kata has different trainers for different inhalation devices. This study investigates the possible positive effects of the Kata® Inhalation App. The main goal of the study is to:

1. 1.investigate the effect of using the Kata® App on adherence for inhaled drugs in adult asthma patients. It consists of two parts: the correct use of the inhalers; and compliance with the therapy, or how much the patient follows the therapy plan as prescribed.
2. 2.investigate the effect of using the Kata® App on asthma symptoms and asthma control, as measured by the Asthma Control Test (ACT) questionnaire.

Conditions

Asthma

Keywords

Asthma; Asthma control; Adherence; Inhalation technique; Inhaler; Digital therapeutics; Smartphone application

Outcome Measures

Primary Outcomes (2)

• Change in the average number of handling errors per inhalation compared between the intervention and control group

  Based on the recordings of the inhalation maneuvers from each data collection period, the inhaler handling and inhalation technique of each subject will be evaluated centrally by trained blinded personnel, based on the applicable German Airway League checklists for inhalation maneuvers (Checklisten Deutsche Atemwegsliga).

  Change in average number of handling errors per inhalation from baseline (study week 1) to the final intervention week (study week 13)

• Change in Asthma Control Test (ACT) score compared between the intervention and control group

  The ACT consists of 5 questions (items) to assess the subject's asthma symptom control within the last 4 weeks. Each question can be answered on a 5-point numerical scale from 1 (worst) to 5 (best). The ACT score is the total score of all items. An ACT score of ≤ 15 points means "no asthma control", a score of 16 to 19 points means "partial asthma control" and a score of ≥ 20 points means "complete asthma control". These are the 3 ACT asthma control classes. The minimal clinically important difference for the ACT is 3 points. The ACT will be completed during each data collection period. The questionnaire will be made available within the smartphone application. Subjects will be reminded to complete the ACT.

  Change in ACT score from baseline (study week 1) to the final intervention week (study week 13)

Secondary Outcomes (1)

• Change in the Test of Adherence for Inhalers (TAI) score (patient domain) compared between the intervention and control group

  Change in TAI score from baseline (study week 1) to the final intervention week (study week 13)

Study Arms (2)

Intervention

EXPERIMENTAL

Kata Inhalations-App with the following functions: 1. Inhalation reminder 2. Inhalation trainer 3. Health parameter documentation 4. Diary 5. Audio and video recording of user's inhalation maneuvers 6. Provision of study-specific questionnaires 7. Reminder to fill out study-specific questionnaires

Device: Kata Inhalations-App

Control

NO INTERVENTION

Messinstrument ("Measurement")-App. Smartphone application with the following functions: 1. Audio and video recording of user's inhalation maneuvers 2. Provision of study-specific questionnaires 3. Reminder to fill out study-specific questionnaires Note: the Messinstrument-App does not provide any inhalation training, inhalation reminders, or feedback.

Interventions

Kata Inhalations-App DEVICE

The Kata Inhalations-App is a digital product that bears a CE mark. The application provides algorithms to run an inhalation trainer. The inhalation trainer shows patients how to improve their inhalation maneuver in a simple and understandable way. For this purpose, the signals from the camera and microphone of the patient's smartphone are used to evaluate the individual steps of the inhalation maneuver in real-time to provide automatic, personalized feedback. Additional functions of the Kata Inhalations-App include the possibility to document health parameters and to receive inhalation reminders. After set-up, subjects will use the application on their own as an add-on to their usual therapy for asthma. The total duration of application use will be 13 weeks, 1 week use of the Messinstrument ("Measurement")-App for all subjects (Baseline period), followed by 12 weeks use of the Kata Inhalations-App (intervention) or the Messinstrument-App (control).

Intervention

Eligibility Criteria

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

You may qualify if:

• A subject is eligible to be included in the study only if all of the following criteria apply:
• Age
• At least 18 years of age at the time of signing the informed consent.
• Sex
• Male or female.
• Type of Subject and Disease Characteristics
• Sufficient knowledge of the German language as assessed by the Investigator.
• Capability to use a smartphone comfortably in the opinion of the Investigator: the subject uses a smartphone on a regular basis, and makes use of smartphone applications (i.e., uses the smartphone for more than calling and sending text messages).
• Established diagnosis of asthma.
• Regular use (i.e., at least once daily) of at least 1 of the following devices: metered-dose inhalers (MDIs), Respimat, NEXThaler, Ellipta, Easyhaler, Breezhaler and Turbohaler.
• Stable disease (i.e., no exacerbation and/or change in treatment regimen) within the last 4 weeks prior to screening.
• Informed Consent
• Provision of written informed consent prior to any study specific procedure.

You may not qualify if:

• Subjects are excluded from the study if any of the following criteria apply:
• Medical Conditions
• History or evidence of any clinically relevant and/or major disease that, in the opinion of the Investigator, would constitute a risk when taking part in the study or interfere with the interpretation of data.
• Confirmed SARS-CoV-2 infection at screening.
• Prior/Concomitant Therapy
• Previous use of the Kata Inhalations-App.
• Prior/Concurrent Clinical Study Experience
• Use of any investigational drug or participation in any clinical study within 30 days prior to the expected date of first application of study intervention.
• Previous randomization in this study.
• Employee of VisionHealth, the study site, the Nuvisan Group, or other Contract Research Organization involved in the study.
• Legal incapacity or limited legal capacity, or incarceration.
• Inability to understand or communicate reliably with the Investigator or considered by the Investigator to be unable to or unlikely to co-operate with the protocol requirements, instructions, and study-related restrictions.
• Any other conditions or factors which in the opinion of the Investigator may interfere with study conduct.

Sponsors & Collaborators

• VisionHealth GmbH: lead
• Thoraxklinik-Heidelberg gGmbH: collaborator

Study Sites (13)

Thoraxklinik Heidelberg gGmbH

Heidelberg, Baden-Wurttemberg, 69126, Germany

Location

MVZ Dachau

Dachau, Bavaria, 85221, Germany

Location

Lunge im Zentrum

Erlangen, Bavaria, 91054, Germany

Location

Herzzentrum des Universitätsklinikums Bonn

Bonn, Germany

Location

Krankenhaus der Augustinerinnen

Cologne, Germany

Location

Lungenzentrum Darmstadt

Darmstadt, Germany

Location

Studienzentrum Dr. Keller

Frankfurt am Main, Germany

Location

Marienkrankenhaus Kassel - Pneumologie

Kassel, Germany

Location

Allgemeinmedizin Untermenzing

München, Germany

Location

Lungenärzte am Rundfunkplatz

München, Germany

Location

Facharztpraxis für Innere Medizin - Pneumologie - Allergologie

Oberursel, Germany

Location

Lungenarztpraxis Dr. med. Maria Weber

Wiesbaden, Germany

Location

Pneumologische Praxis Wiesbaden

Wiesbaden, Germany

Location

Related Publications (4)

• Melani AS, Bonavia M, Cilenti V, Cinti C, Lodi M, Martucci P, Serra M, Scichilone N, Sestini P, Aliani M, Neri M; Gruppo Educazionale Associazione Italiana Pneumologi Ospedalieri. Inhaler mishandling remains common in real life and is associated with reduced disease control. Respir Med. 2011 Jun;105(6):930-8. doi: 10.1016/j.rmed.2011.01.005. Epub 2011 Mar 2.

  PMID: 21367593 BACKGROUND

• Normansell R, Kew KM, Mathioudakis AG. Interventions to improve inhaler technique for people with asthma. Cochrane Database Syst Rev. 2017 Mar 13;3(3):CD012286. doi: 10.1002/14651858.CD012286.pub2.

  PMID: 28288272 BACKGROUND

• O'Dwyer S, Greene G, MacHale E, Cushen B, Sulaiman I, Boland F, Bosnic-Anticevich S, Mokoka MC, Reilly RB, Taylor T, Ryder SA, Costello RW. Personalized Biofeedback on Inhaler Adherence and Technique by Community Pharmacists: A Cluster Randomized Clinical Trial. J Allergy Clin Immunol Pract. 2020 Feb;8(2):635-644. doi: 10.1016/j.jaip.2019.09.008. Epub 2019 Sep 27.

  PMID: 31568927 BACKGROUND

• Sulaiman I, Greene G, MacHale E, Seheult J, Mokoka M, D'Arcy S, Taylor T, Murphy DM, Hunt E, Lane SJ, Diette GB, FitzGerald JM, Boland F, Sartini Bhreathnach A, Cushen B, Reilly RB, Doyle F, Costello RW. A randomised clinical trial of feedback on inhaler adherence and technique in patients with severe uncontrolled asthma. Eur Respir J. 2018 Jan 4;51(1):1701126. doi: 10.1183/13993003.01126-2017. Print 2018 Jan.

  PMID: 29301919 BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The Investigator, the subjects and the data analyst will not be blinded. The persons evaluating the recordings of inhalation maneuvers will be blinded to study intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter study in up to 15 study sites in Germany that follows a randomized, controlled, parallel-group, adaptive two-stage design.

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 21, 2023
• Study Start: December 20, 2023
• Primary Completion: January 14, 2025
• Study Completion: January 14, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (13)