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NCT Number: NCT07629830

Post Exacerbation Asthma Clinic Telecare Intervention 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.

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.

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Key information

Conditions

Asthma Acute Asthma Attack

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Asthma Exacerbations Rate

    Time frame: From enrollment to 3 months

    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.

Secondary outcomes

  1. Hospital Arrival due to asthma exacerbations

    Time frame: From enrollment to 3 months

    The rate of asthma exacerbations leading to hospital arrival between the intervention and control.

  2. Change in Asthma Control Test (ACT) score

    Time frame: From enrollment to 3 months

    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.

  3. Adherent to Treatment Guidelines

    Time frame: From enrollment to 3 months

    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.

  4. Percentage of ≥1 asthma exacerbations

    Time frame: From enrollment to 3 months

    The percentage of patients in each study groups that had ≥1 asthma exacerbations.

  5. Asthma Exacerbations Rate - extended follow-up

    Time frame: From enrollment to 12 months

    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.

  6. Hospital Arrival due to asthma exacerbations - extended follow-up

    Time frame: From enrollment to 12 months

    The rate of asthma exacerbations leading to hospital arrival between the intervention and control.

  7. Change in Asthma Control Test (ACT) score - extended follow-up

    Time frame: From enrollment to 12 months

    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.

  8. Adherent to Treatment Guidelines - extended follow-up

    Time frame: From enrollment to 12 months

    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.

  9. Exacerbation Frequency

    Time frame: From 12 months prior to enrollment through 12 months following enrollment.

    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.

  10. Percentage of ≥1 asthma exacerbations - extended follow-up

    Time frame: From enrollment to 12 months

    The percentage of patients in each study groups that had ≥1 asthma exacerbations.

Study contacts

Contact information is provided by the study sponsor or research team.

Amir Bar-Shai

CONTACT

[email protected]

+972-507265248

Sponsors and collaborators

Lead sponsor

Tel-Aviv Sourasky Medical Center

Other Gov

Collaborators

  • The Dalia and Eli Hurvitz Foundation Grant

Registry information

Official study title

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

Acronym: PACT

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 5, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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