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

18 czerwca 2026 zaktualizowane przez: Tel-Aviv Sourasky Medical Center

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.

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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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).

Typ studiów

Interwencyjne

Zapisy (Szacowany)

220

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Izrael
      • Tel Aviv, Izrael
        • Tel-Aviv Sourasky Medical Center, Tel Aviv
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Brak interwencji: 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.
Eksperymentalny: 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.
Inny: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Asthma Exacerbations Rate
Ramy czasowe: 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.
From enrollment to 3 months

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Hospital Arrival due to asthma exacerbations
Ramy czasowe: From enrollment to 3 months
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
Ramy czasowe: 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.
From enrollment to 3 months
Adherent to Treatment Guidelines
Ramy czasowe: 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.
From enrollment to 3 months
Percentage of ≥1 asthma exacerbations
Ramy czasowe: From enrollment to 3 months
The percentage of patients in each study groups that had ≥1 asthma exacerbations.
From enrollment to 3 months
Asthma Exacerbations Rate - extended follow-up
Ramy czasowe: 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.
From enrollment to 12 months
Hospital Arrival due to asthma exacerbations - extended follow-up
Ramy czasowe: From enrollment to 12 months
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
Ramy czasowe: 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.
From enrollment to 12 months
Adherent to Treatment Guidelines - extended follow-up
Ramy czasowe: 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.
From enrollment to 12 months
Exacerbation Frequency
Ramy czasowe: 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.
From 12 months prior to enrollment through 12 months following enrollment.
Percentage of ≥1 asthma exacerbations - extended follow-up
Ramy czasowe: From enrollment to 12 months
The percentage of patients in each study groups that had ≥1 asthma exacerbations.
From enrollment to 12 months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Tel-Aviv Sourasky Medical Center

Współpracownicy

The Dalia and Eli Hurvitz Foundation Grant

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 lipca 2026

Zakończenie podstawowe (Szacowany)

31 grudnia 2028

Ukończenie studiów (Szacowany)

31 grudnia 2028

Daty rejestracji na studia

Pierwszy przesłany

1 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

1 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

5 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

22 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

18 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • 0034-26-TLV

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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