Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06178341
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2023-11-23
Brief Title:
Effects of the Kata Inhalations-App on Inhaler Handling Errors Adherence and Asthma Control in Patients With Asthma
Sponsor:
VisionHealth GmbH
Organization:
VisionHealth GmbH
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 inhalers 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
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 inhalers 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None