Post Exacerbation Asthma Clinic Telecare Intervention to Reduce Recurrent Exacerbations

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Другое 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 mo

Первичные конечные точки

• Asthma Exacerbations Rate [Срок оценки: From enrollment to 3 months]

Вторичные конечные точки (10)

• Hospital Arrival due to asthma exacerbations [Срок оценки: From enrollment to 3 months]
• Change in Asthma Control Test (ACT) score [Срок оценки: From enrollment to 3 months]
• Adherent to Treatment Guidelines [Срок оценки: From enrollment to 3 months]
• Percentage of ≥1 asthma exacerbations [Срок оценки: From enrollment to 3 months]
• Asthma Exacerbations Rate - extended follow-up [Срок оценки: From enrollment to 12 months]
• Hospital Arrival due to asthma exacerbations - extended follow-up [Срок оценки: From enrollment to 12 months]
• Change in Asthma Control Test (ACT) score - extended follow-up [Срок оценки: From enrollment to 12 months]
• Adherent to Treatment Guidelines - extended follow-up [Срок оценки: From enrollment to 12 months]
• Exacerbation Frequency [Срок оценки: From 12 months prior to enrollment through 12 months following enrollment.]
• Percentage of ≥1 asthma exacerbations - extended follow-up [Срок оценки: From enrollment to 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Израиль · 1 центр

• Tel-Aviv Sourasky Medical Center, Tel Aviv — Tel Aviv

Идентификаторы

NCT: NCT07629830 · 0034-26-TLV

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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