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

18 de junho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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).

Tipo de estudo

Intervencional

Inscrição (Estimado)

220

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Israel
      • Tel Aviv, Israel
        • Tel-Aviv Sourasky Medical Center, Tel Aviv
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Sem intervenção: 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.
Outro: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Asthma Exacerbations Rate
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Hospital Arrival due to asthma exacerbations
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: From enrollment to 12 months
The percentage of patients in each study groups that had ≥1 asthma exacerbations.
From enrollment to 12 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Tel-Aviv Sourasky Medical Center

Colaboradores

The Dalia and Eli Hurvitz Foundation Grant

Publicações e links úteis

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Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de julho de 2026

Conclusão Primária (Estimado)

31 de dezembro de 2028

Conclusão do estudo (Estimado)

31 de dezembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

1 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de junho de 2026

Primeira postagem (Real)

5 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

18 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • 0034-26-TLV

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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