Post Exacerbation Asthma Clinic Telecare Intervention to Reduce Recurrent Exacerbations

NCT07629830 | Not Yet Recruiting

• 1 other identifier: 0034-26-TLV
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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. Our 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. 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. 2.Control group - will continue standard community care without additional intervention.

Conditions

Asthma Attack; Asthma Acute

Keywords

Asthma flare-up; Asthma management; remote clinic; pulmonologist

Outcome Measures

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.

  From enrollment to 3 months

Secondary Outcomes (10)

• Hospital Arrival due to asthma exacerbations

  From enrollment to 3 months

• Change in Asthma Control Test (ACT) score

  From enrollment to 3 months

• Adherent to Treatment Guidelines

  From enrollment to 3 months

• Percentage of ≥1 asthma exacerbations

  From enrollment to 3 months

• Asthma Exacerbations Rate - extended follow-up

  From enrollment to 12 months

Study Arms (2)

Control

NO INTERVENTION

Participants in the control group will continue standard community-based medical care following discharge from the emergency department or hospitalization for asthma exacerbation, without additional remote pulmonology intervention. Follow-up assessments will be conducted by the research coordinator at predefined time points for study outcome evaluation only.

Remote Flare-Up Clinic

EXPERIMENTAL

Participants in the intervention group will undergo structured remote pulmonology follow-up through secure video consultations conducted 7-21 days and 5 months after discharge following an asthma exacerbation. The remote visits will include assessment of asthma control and exacerbation history, inhaler technique evaluation, treatment optimization according to current guidelines, and asthma self-management education. Visit summaries and treatment recommendations will be documented in the electronic medical record and provided to the participant. Additional follow-up phone assessments will be conducted by the research coordinator at predefined time points for study outcome evaluation.

Other: Follow-up in a remote flare-up clinic

Interventions

Follow-up in a remote flare-up clinic OTHER

Participants 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.

Remote Flare-Up Clinic

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Uncontrolled cardiac disease.
• Any other uncontrolled medical condition.
• Inability to complete telephone follow-up.
• Pregnancy.
• Patients lacking decision-making capacity.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• The Dalia and Eli Hurvitz Foundation Grant: collaborator

Study Sites (1)

Tel-Aviv Sourasky Medical Center, Tel Aviv

Tel Aviv, Israel

Location

Related Links

• 2023 GINA Main Report. Global Initiative for Asthma - GINA
• High Prevalence of Severe Asthma in a Large Random Population Study.
• The Barriers to Accessing Primary Care Resulting in Hospital Presentation for Exacerbation of Asthma or Chronic Obstructive Pulmonary Disease in a Large Teaching Hospital in London.
• Asthma Patients' and Physicians' Perspectives on the Burden and Management of Asthma.
• Asthmatic Patients' Poor Awareness of Inadequate Disease Control: A Pharmacy-Based Survey.
• Prevalence, Risk Factors, and Management of Asthma in China: A National Cross-Sectional Study.
• Positive Change in Asthma Control Using Therapeutic Patient Education in Severe Uncontrolled Asthma: A One-Year Prospective Study.
• Economic Evidence for US Asthma Self-Management Education and Home-Based Interventions.

Central Study Contacts

Amir Bar-Shai

CONTACT

+972-507265248; amirbs@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data collection during the phone-calls in both groups will be conducted by personnel blinded to group allocation. All outcomes will be filled in a similar form without identifying information and stored in a combined folder for both the intervention and control groups. Data will be entered to the study database by personnel blinded to group allocation. The statistical analysis will be performed by a statistician blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: For inclusion, all patients presenting to the emergency department at Tel Aviv Sourasky Medical Center with an asthma exacerbation will be identified weekly using the institutional electronic medical records system (Chameleon). The diagnosis of asthma exacerbation and eligibility for enrollment will be verified by a study pulmonologist. Eligible patients will be contacted by the research coordinator within one week of discharge, provided with information regarding the study, and asked for preliminary agreement to participate. Following informed consent, participants will undergo 1:1 randomization to either the intervention or control group using sealed identical envelopes prepared in advance. The intervention group will participate in structured remote pulmonology visits conducted 7-21 days and 5 months after discharge, while the control group will continue standard community care with follow-up assessments only.

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 5, 2026

Record last verified: 2026-06

Locations

IL (1)