Post Exacerbation Asthma Clinic Telecare Intervention to Reduce Recurrent Exacerbations (PACT)

A Remote Clinic Intervention Following Hospital Discharge for Asthma Exacerbation to Reduce Recurrent Exacerbations

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. 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Asthma Attack; Asthma Acute
• Intervention / Treatment: Other: Follow-up in a remote flare-up clinic

Detailed Description

Data collection:

Participants will be followed for 12 months after enrollment. In the intervention group, remote clinic visits will be conducted 7-21 days after discharge and again 5 months after enrollment. In addition, follow-up phone calls will be conducted at 3 months, 9 months, and 12 months after enrollment. The control group will undergo follow-up phone calls at the same assessment time points, without remote clinic intervention.

Data collected will include recurrent exacerbations, systemic corticosteroid use, emergency department visits, hospitalizations, medication changes, rescue inhaler use, and asthma symptom burden assessed using the Asthma Control Test (ACT).

Participants will be randomized to their respective intervention groups using a secure system of sequentially numbered, opaque, sealed envelopes (SNOSE) containing the treatment assignments. To maintain strict allocation concealment and minimize selection bias, the entire randomization process will be managed exclusively by an independent study coordinator. The principal investigators and clinical research team members directly involved in participant enrollment, care, and data collection will have no involvement in the generation, maintenance, or opening of the assignment envelopes. The independent coordinator will open the designated envelope only after a participant has successfully completed the baseline assessment and met all eligibility criteria.

Sample Size Calculation:

Based on preliminary data, the average exacerbation rate during the first 3 months is expected to be 0.25 exacerbations per patient in the control group and 0.10 in the intervention group. To detect this difference with 80% power and a significance level of 0.05, 100 participants are required in each group. Assuming a 10% loss to follow up, the planned sample size is 220 participants (110 participants per group).

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amir Bar-Shai; Phone Number: +972-507265248; Email: amirbs@tlvmc.gov.il

Study Locations

• Israel
  • Tel Aviv, Israel
    • Tel-Aviv Sourasky Medical Center, Tel Aviv
    • Contact: Amir Bar-Shai, MD; Phone Number: +972-507265248; Email: amirbs@tlvmc.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 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.
Experimental: Remote Flare-Up Clinic; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Arrival due to asthma exacerbations	The rate of asthma exacerbations leading to hospital arrival between the intervention and control.	From enrollment to 3 months
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.	From enrollment to 3 months
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.	From enrollment to 3 months
Percentage of ≥1 asthma exacerbations	The percentage of patients in each study groups that had ≥1 asthma exacerbations.	From enrollment to 3 months
Asthma Exacerbations Rate - extended follow-up	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 12 months
Hospital Arrival due to asthma exacerbations - extended follow-up	The rate of asthma exacerbations leading to hospital arrival between the intervention and control.	From enrollment to 12 months
Change in Asthma Control Test (ACT) score - extended follow-up	Change in asthma control score from baseline to 12 months between the intervention and control. Values range 5-25, with higher scores indicating better control.	From enrollment to 12 months
Adherent to Treatment Guidelines - extended follow-up	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 12-months follow-up.	From enrollment to 12 months
Exacerbation Frequency	Change in exacerbation frequency during the first year following enrollment compared to the year prior to study enrollment, defined as the percentage change in the rate of severe asthma exacerbations before and after the intervention.	From 12 months prior to enrollment through 12 months following enrollment.
Percentage of ≥1 asthma exacerbations - extended follow-up	The percentage of patients in each study groups that had ≥1 asthma exacerbations.	From enrollment to 12 months

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Collaborators: The Dalia and Eli Hurvitz Foundation Grant

Publications and helpful links

Helpful 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.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Asthma management; Asthma flare-up; pulmonologist; remote clinic
• Other Study ID Numbers: 0034-26-TLV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No