Clinical trial NCT06178341: Effects of the Kata® Inhalations-App on Inhaler Handling Errors, Adherence, and Asthma Control in Patients With Asthma.
Official title: Randomized, Controlled Study to Evaluate the Effectiveness of the Kata® Inhalations-App in Reducing Critical and Non-critical Handling Errors and Improving Adherence to Prescribed Drug Inhalation Therapy and Asthma Control in Adult Patients With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Asthma control
Adherence
Inhalation technique
Inhaler
Digital therapeutics
Smartphone application
Lead sponsor: VisionHealth GmbH
Sponsor class: INDUSTRY
Collaborators: name: Thoraxklinik-Heidelberg gGmbH
First posted: 2023-12-21
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter study in up to 15 study sites in Germany that follows a randomized, controlled, parallel-group, adaptive two-stage design.
Primary purpose: TREATMENT

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. 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. investigate the effect of using the Kata® App on asthma symptoms and asthma control, as measured by the Asthma Control Test (ACT) questionnaire.

In addition, asthma-related quality of life, lung function, and ease of use of the app will be assessed during the study.

This multicenter study follows a randomized, controlled, parallel-group, adaptive two-stage design. The study includes two different groups: an intervention and a control group. At the beginning of the study, each patient is randomly assigned to one of these two groups. The total duration of the study is 13 weeks: 1 baseline week and 12 intervention weeks. During the baseline week, the intervention and control group both use the app with limited functionality. Kata records their inhalations but does not provide inhalation training or feedback. This is to first assess how well patients are able to use their inhaler(s) without receiving support. After the first week, the intervention group starts using the app with full functionality for 12 weeks, which means that the app provides them with inhalation training and personalized feedback. The control group continues to use the app with limited functionality for 12 weeks, that means that they continue to use the app to record their inhalations but do not receive any inhalation training or feedback. This study will compare the patients in the intervention and control group, to find out the effect of using the Kata® inhalation app on the number of errors patients make when using their inhaler, therapy compliance, and health-related outcomes (asthma control, quality of life, and lung function).


Eligibility criteria: Inclusion Criteria

A subject is eligible to be included in the study only if all of the following criteria apply:

Age

1. At least 18 years of age at the time of signing the informed consent.

   Sex
2. Male or female.

   Type of Subject and Disease Characteristics
3. Sufficient knowledge of the German language as assessed by the Investigator.
4. 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).
5. Established diagnosis of asthma.
6. 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.
7. Stable disease (i.e., no exacerbation and/or change in treatment regimen) within the last 4 weeks prior to screening.

   Informed Consent
8. Provision of written informed consent prior to any study specific procedure.

Exclusion Criteria

Subjects are excluded from the study if any of the following criteria apply:

Medical Conditions

1. 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.
2. Confirmed SARS-CoV-2 infection at screening.

   Prior/Concomitant Therapy
3. Previous use of the Kata Inhalations-App.

   Prior/Concurrent Clinical Study Experience
4. 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.
5. Previous randomization in this study.

   Other Exclusions
6. Employee of VisionHealth, the study site, the Nuvisan Group, or other Contract Research Organization involved in the study.
7. Legal incapacity or limited legal capacity, or incarceration.
8. 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.
9. Any other conditions or factors which in the opinion of the Investigator may interfere with study conduct.

Primary outcomes:
measure: Change in the average number of handling errors per inhalation compared between the intervention and control group
timeFrame: Change in average number of handling errors per inhalation from baseline (study week 1) to the final intervention week (study week 13)
measure: Change in Asthma Control Test (ACT) score compared between the intervention and control group
timeFrame: Change in ACT score from baseline (study week 1) to the final intervention week (study week 13)
Secondary outcomes:
measure: Change in the Test of Adherence for Inhalers (TAI) score (patient domain) compared between the intervention and control group
timeFrame: Change in TAI score from baseline (study week 1) to the final intervention week (study week 13)
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg gGmbH
state: Baden-Wuerttemberg
city: Dachau
country: Germany
facility: MVZ Dachau
state: Bayern
city: Erlangen
country: Germany
facility: Lunge im Zentrum
state: Bayern
city: Bonn
country: Germany
facility: Herzzentrum des Universitätsklinikums Bonn
city: Darmstadt
country: Germany
facility: Lungenzentrum Darmstadt
city: Frankfurt am main
country: Germany
facility: Studienzentrum Dr. Keller
city: Kassel
country: Germany
facility: Marienkrankenhaus Kassel - Pneumologie
city: Köln
country: Germany
facility: Krankenhaus der Augustinerinnen
city: München
country: Germany
facility: Allgemeinmedizin Untermenzing
city: München
country: Germany
facility: Lungenärzte am Rundfunkplatz
city: Oberursel
country: Germany
facility: Facharztpraxis für Innere Medizin - Pneumologie - Allergologie
city: Wiesbaden
country: Germany
facility: Lungenarztpraxis Dr. med. Maria Weber
city: Wiesbaden
country: Germany
facility: Pneumologische Praxis Wiesbaden
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.