Post Exacerbation Asthma Clinic Telecare Intervention to Reduce Recurrent Exacerbations
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTel-Aviv Sourasky Medical Center
About this trial
Asthma exacerbations leading to emergency department visits or hospitalization are associated with a high risk of recurrent exacerbations, poor disease control, and increased healthcare utilization in the months following discharge. Early specialist follow-up during this vulnerable transition period remains limited, and many patients do not receive optimized long-term asthma management. The purpose of this study is to evaluate whether a structured remote asthma clinic intervention initiated shortly after hospital discharge can reduce recurrent exacerbations and improve asthma-related outcomes compared to standard community care.
This prospective randomized study will enroll 220 adult patients (18-75 years) presenting to the emergency department at Tel Aviv Sourasky Medical Center with an asthma exacerbation. Participants will be randomly assigned to one of two groups:
1. Intervention group - will undergo two structured remote pulmonology follow-up visits via secure video consultation within 7-21 days and 5 months after discharge, including treatment optimization, inhaler technique assessment, and self-management education. 2. Control group - will continue standard community care without additional intervention.
All participants will complete scheduled follow-up assessments over 12 months, including evaluation of exacerbations, asthma control, healthcare utilization, and medication use.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Presentation to the emergency department with an asthma exacerbation.
Ability to complete telephone follow-up and access to a personal e-mail account.
Agreement to participate in the study.
Written or verbal informed consent according to study group assignment.
Disqualifiers
Uncontrolled cardiac disease.
Any other uncontrolled medical condition.
Inability to complete telephone follow-up.
Pregnancy.
Trial design
Design model
Parallel
Treatments tested in this trial
Follow-up in a remote flare-up clinic
Other interventionParticipants assigned to the intervention group will undergo two structured remote pulmonology visits via secure video consultation, conducted 7-21 days and 5 months after discharge following an asthma exacerbation. The intervention will include assessment of asthma control and exacerbation history, inhaler technique evaluation, treatment optimization, and asthma self-management education according to current guidelines. Additional follow-up phone assessments will be conducted at 3, 9, and 12 months for study outcome evaluation only.
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: Remote Flare-Up ClinicExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Asthma Exacerbations Rate
The primary outcome will be the rate of severe asthma exacerbations, assessed as the total number of severe asthma exacerbations following enrollment divided by the number of participants in each study group. The primary analysis will be performed according to the intention-to-treat principle. severe asthma exacerbations defined as worsening asthma requiring treatment with systemic glucocorticoids for at least 3 days or worsening symptoms leading to an emergency department visit or hospitalization.
Time frame
From enrollment to 3 monthsSecondary outcomes
1
Hospital Arrival due to asthma exacerbations
The rate of asthma exacerbations leading to hospital arrival between the intervention and control.
Time frame
From enrollment to 3 months2
Change in Asthma Control Test (ACT) score
Change in asthma control score from baseline to 3 months between the intervention and control. Values range 5-25, with higher scores indicating better control.
Time frame
From enrollment to 3 months3
Adherent to Treatment Guidelines
Treatment adhere to the Global Initiative for Asthma (GINA) guidelines based on disease severity, in the intervention vs. the control. This will be defined as the percentage of patients taking the GINA-recommended inhaled corticosteroid dose, as self-reported in the 3-months follow-up.
Time frame
From enrollment to 3 months4
Percentage of ≥1 asthma exacerbations
The percentage of patients in each study groups that had ≥1 asthma exacerbations.
Time frame
From enrollment to 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tel-Aviv Sourasky Medical Center
Lead sponsor
The Dalia and Eli Hurvitz Foundation Grant
Collaborator
Source ClinicalTrials.gov