REACT - REAl Care for AsThma - A Disease Study to Identify Patients With Severe Uncontrolled Asthma
- Conditions
- Asthma, Bronchial
- Registration Number
- NCT06299306
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 19
- ≥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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of severe asthma patients with an Asthma Impairment and Risk Questionnaire (AIRQ®) score at baseline, and at 6 and 12 months post enrollment. Up to 12 months To ascertain the level of asthma control of the study population by the AIRQ® assessment.
The AIRQ® includes 10 questions (7 assessing symptom impairment and 3 assessing risk) concerning patient medication use, asthma symptoms, medical visits, and tests.
The AIRQ® can predict the risk for exacerbations and assess the quality of life of asthma patients.
AIRQ® score: well-controlled (0-1 points), not well-controlled (2-4 points) and very poorly controlled (≥5 points) asthma
- Secondary Outcome Measures
Name Time Method Changes in the AIRQ® impairment domain score Up to 12 months To evaluate changes in quality of life (AIRQ® 7 impairment questions) of patients compared to baseline.
Changes in the AIRQ® risk domain score Up to 12 months To assess changes in the patients' risk level of exacerbations (AIRQ® 3 risk questions) compared to baseline.
Changes in the AIRQ® total score Up to 12 months To assess changes in asthma control compared with baseline assessment.
Proportion of patients with prescribed use of oral corticosteroids (OCS) Up to 12 months To evaluate changes in prescribed daily OCS dose, prescribed cumulative OCS dose, percentage change in prescribed cumulative OCS dose, proportion of patients with prescribed ≤5 mg/day and prescribed \>5mg/day OCS at baseline, months 6 and 12 post enrollment based on information collected via electronic medical records (EMRs).
Assessment of the patient satisfaction with digital and analog healthcare Up to 12 months To assess the patient-reported attitude towards digital and analog healthcare at months 3, 6, and 12 post enrollment through patient-reported experience measurement (patient PREM) questionnaires. The patient PREM questionnaire includes 16 questions with regard to the experience with the program, the communication/interaction and the evaluation of the program.
Proportion of patients with a change in other asthma therapies Up to 12 months To assess changes in other asthma therapies at 6 and 12 months post enrollment compared to baseline based on prescribed medication as documented in EMRs.
Assessment of the patient-reported 1-year prior healthcare utilization 12 months To assess the patient-reported healthcare utilization (HCRU) at 12 months post enrollment compared with baseline assessment. The patient HCRU questionnaire includes 4 questions with regard to healthcare utilization.
Bi-weekly changes in the AIRQ® total score over time Up to 12 months To assess changes in asthma control over time.
Proportion of patients with self-reported OCS use Up to 12 months To evaluate changes in self-reported daily OCS dose, cumulative OCS dose, percentage change in cumulative OCS dose, proportion of patients with ≤5 mg/day and \>5mg/day OCS at baseline, months 6 and 12 post enrollment based on information via the AIRQ®-Active app or the paper medication diary.
Treatment switches (change in prescribed therapies) over time and time on treatment. Up to 12 months To assess changes in other asthma therapies over time and time on treatment compared to baseline based on prescribed medication as documented in EMRs.
Changes in lung function parameters - Tiffenau-Index Up to 12 months To evaluate changes in lung function by using a spirometer. From the spirometry measurements (FEV1, FVC) the Tiffenau-Index (FEV1/FVC) will be calculated.
Correlations between environmental factors and patients' asthma exacerbations Up to 12 months To evaluate the relationship of environmental factors like levels of allergen flight, fine particle load, ozone levels, air pollution, and duration of sunshine related to asthma exacerbations at 6 months and 12 months based on environmental databases.
Changes in laboratory parameter - blood neutrophil Up to 12 months To evaluate the level of patients' blood neutrophil. Counts of blood neutrophil, measured in cells per microliter or percentage (%) of the total cell count.
Changes in laboratory parameter - FeNO Up to 12 months To evaluate patients' FeNO concentration. Measurements of FeNO concentration in exhaled breath, measured in parts per billion (ppb) at a flow rate of 50 milliliters per second (mL/s)
Changes in lung function parameters - FEV1 % Up to 12 months To evaluate changes in lung function by using a spirometer. From the spirometry measurements (FEV1) the predicted FEV1 % will be calculated.
Assessment of the healthcare provider (physician) satisfaction with digital and analog healthcare Up to 12 months To assess the healthcare provider-reported attitude towards digital and analog healthcare and provider-reported preferences in monitoring tools through provider-reported experience measurement (provider PREM) questionnaires at months 3, 6, and 12 post recruitment.
The provider PREM questionnaire assessing the satisfaction with digital and analog healthcare includes 15 questions with regard to the experience with the program, the communication/interaction and the evaluation of the program.Assessment of the provider preferences in digital versus analog healthcare monitoring. Up to 12 months To assess the provider-reported preferences in monitoring tools through provider-reported experience measurement (provider PREM) questionnaires at months 3, 6, and 12 post recruitment.
The provider PREM questionnaire assessing the preferences in digital and analog healthcare includes 3 questions with regard to integration and communication, medicinal benefit, and economic benefit.Number and type of recorded comorbidity-related events overall and in patients with self-reported OCS Baseline To describe the number of comorbidity-related events during the study among overall patients and in the subgroup of patients with self-reported OCS use based on information collected via electronic case report form (eCRF).
Changes in laboratory parameter - C-reactive protein (CRP) level Up to 12 months To evaluate patients' C-reactive protein (CRP) level. Measured in milligrams per liter (mg/L)
Assessment of the patient preferences towards remote monitoring and healthcare delivery. 6 months To elicit the preferences of patients towards remote monitoring and healthcare delivery over time using a Discrete Choice Experiment (DCE) questionnaire at baseline and 6 months post enrollment. The DCE questionnaire is a 4 choice task based questionnaire.
Changes in laboratory parameter - IgE level Up to 12 months To evaluate patients' IgE level. Counts of IgE, measured in kilounits per liter (kU/L) or international units per liter (IU/mL)
Correlation between environmental factors and changes in AIRQ® score Up to 12 months To evaluate the relationship of environmental factors like levels of allergen flight, fine particle load, ozone levels, air pollution, and duration of sunshine related to the patients´well-being (AIRQ® score) at 6 months and 12 months based on information of environmental databases.
Changes in laboratory parameter - blood eosinophil Up to 12 months To evaluate the level of patients' blood eosinophil. Counts of blood eosinophils, measured in cells per microliter or percentage (%) of the total cell count.
Trial Locations
- Locations (1)
Research Site
🇩🇪Weissenburg, Germany