The goal of this study is to assess the effectiveness of the Indian Asthma Care Bundle (I-ACB) in improving post-discharge asthma management among patients with asthma in India, specifically targeting adults and children experiencing severe asthma exacerbations.
The main questions it aims to answer are:
1. Does the I-ACB reduce the rate of hospital readmissions within 30, 60, and 90 days post-discharge? 2. How does the I-ACB impact treatment adherence, lung function, symptom control, and overall quality of life, compared to usual care?
Researchers will compare outcomes among participants receiving the I-ACB with those receiving standard asthma care (usual care) to determine whether the I-ACB improves health outcomes and reduces the need for emergency department visits.
Participants will be asked to:
* Engage in a structured asthma management program that includes education on inhaler techniques and adherence to treatment plans. * Report their symptoms and treatment adherence regularly. * Participate in follow-up assessments that monitor lung function and quality of life over a specified period.
The importance of this study lies in its potential to address significant gaps in asthma management in India, which currently lead to high hospitalisation rates and substantial healthcare costs. By developing a tailored care strategy, the I-ACB aims to improve health outcomes for millions of asthma patients, reducing the burden on families and healthcare systems alike, and ultimately transforming the approach to asthma care in the region.
Adults (≥ 18 years of age) participants with a doctor-diagnosed asthma
admitted to a tertiary care facility/hospital due to an acute asthma exacerbation
attended at least a primary school to read, comprehend, and write English/Hindi/local language
provide informed consent
a diagnosed co-pulmonary condition, such as chronic obstructive pulmonary disease, bronchiectasis, interstitial lung disease or other chronic respiratory disorders
a recent (in the past 6 months) history of hospitalisation due to influenza, pneumonia, or any respiratory tract infections
a recent (in the past 6 months) hospital admission due to a cardiologic condition or under medications such as statins, beta-blockers, blood thinners, etc.
a significant cognitive impairment
Parallel
Indian Asthma Care Bundle (I-ACB)
Other interventionI-ACB is a structured hospital-initiated asthma care bundle (I-ACB), a contextual and India-specific post-discharge care bundle tailored for adult asthma patients hospitalised for asthma.
Hospital readmission or emergency department visit
Any readmission or emergency department within the first 30, 60, and 90 days after discharge from exacerbation-related hospitalisation will be assessed by telephonic interviews or by accessing hospital logs.
Treatment adherence
We will assess their medication adherence using the Medication Adherence Rating Scale (MARS). MARS is a 10-item questionnaire, and has a scale between 0 and 10 where 0 indicates worse compliance and 10 indicates better compliance.
Lung function (Spirometry)
Spirometry will be conducted at home with portable devices during the follow-up visits at 30, 60, and 90 days post-discharge. We will perform these tests according to the established European Respiratory Society/American Thoracic Society guidelines. The following measurements will be taken: Forced vital capacity (Litre), and Forced expiratory volume in 1 second (Litre)
Lung function (Spirometry continued)
Spirometry will be conducted at home with portable devices during the follow-up visits at 30, 60, and 90 days post-discharge. We will perform these tests according to the established European Respiratory Society/American Thoracic Society guidelines. The following measurements will be taken: Maximum expiratory flow at 25th, 50th, and 75th percentiles of the forced vital capacity (all in Litre/second)
Lung function (Oscillometry)
Oscillometry will be conducted at home with portable devices during the follow-up visits at 30, 60, and 90 days post-discharge. We will perform these tests according to the established European Respiratory Society/American Thoracic Society guidelines. The following measurements will be taken: Airway resistance and reactance (all in kilopascals per Litre per second).
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Ahmedabad University
Lead sponsor
Apollo Gleneagles Hospitals, Kolkata
Collaborator
Vardhman Mahavir Medical College And Safdarjung Hospital
Collaborator
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