REACT - REAl Care for AsThma - A Disease Study to Identify Patients With Severe Uncontrolled Asthma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-07

Study Completion Date

2024-11-25

Brief Summary

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This is a multi-center, single-country, single-arm, prospective, disease study to collect real world data of patients with severe uncontrolled asthma in Germany.

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Detailed Description

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This observational disease study aims to improve the understanding of the real-world situation of patients with severe uncontrolled asthma, the influence of environmental factors on the risk of exacerbations as well as the patients' quality of life. The patients will provide self-reported information about their asthma control and medication use in a 12 months period after study enrollment. Additional patient information will be collected from existing electronical records (EMRs). Furthermore, patient- and provider-reported attitude towards healthcare and monitoring (measured through patient- and provider-reported experience measurements \[PREMs\]) will be collected to measure the level of satisfaction with the healthcare provision, digital and analog healthcare support programs, and the preferences in monitoring tools. The information will be collected either digitally with an application or analogically with paper-based questionnaires.

Conditions

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Asthma, Bronchial

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* ≥18 years of age at the time of consent
* Therapy within GINA/NVL steps 4 or 5 and uncontrolled disease in the previous 12 months as per the healthcare provider's assessment
* Willing and able to provide written informed consent indicating that they understand the purpose and procedures required for the study and are willing to participate
* Able to read, understand, and speak German sufficiently to complete all the questionnaires

Exclusion Criteria

* According to the assessment of the study physician: cognitive impairment, psychiatric diseases, severe hearing or vision impairment, insufficient knowledge of the German language, if these factors could influence the ability to provide written consent and correct completion and assessment of the questionnaires.
* Current participation in an observational study that might, in the investigator's opinion, influence the assessment for the current study, or participation in a randomized clinical trial in the last 30 days.

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No