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| Name | Class |
|---|---|
| The Dalia and Eli Hurvitz Foundation Grant | UNKNOWN |
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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:
All participants will complete scheduled follow-up assessments over 12 months, including evaluation of exacerbations, asthma control, healthcare utilization, and medication use.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | 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. | |
| Remote Flare-Up Clinic | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amir Bar-Shai | Contact | +972-507265248 | amirbs@tlvmc.gov.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel-Aviv Sourasky Medical Center, Tel Aviv | Tel Aviv | Israel |
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| Label | URL |
|---|---|
| 2023 GINA Main Report. Global Initiative for Asthma - GINA | View source |
| High Prevalence of Severe Asthma in a Large Random Population Study. | View source |
| 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. |
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For inclusion, all patients presenting to the emergency department at Tel Aviv Sourasky Medical Center with an asthma exacerbation will be identified weekly using the institutional electronic medical records system (Chameleon). The diagnosis of asthma exacerbation and eligibility for enrollment will be verified by a study pulmonologist. Eligible patients will be contacted by the research coordinator within one week of discharge, provided with information regarding the study, and asked for preliminary agreement to participate. Following informed consent, participants will undergo 1:1 randomization to either the intervention or control group using sealed identical envelopes prepared in advance. The intervention group will participate in structured remote pulmonology visits conducted 7-21 days and 5 months after discharge, while the control group will continue standard community care with follow-up assessments only.
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Data collection during the phone-calls in both groups will be conducted by personnel blinded to group allocation. All outcomes will be filled in a similar form without identifying information and stored in a combined folder for both the intervention and control groups. Data will be entered to the study database by personnel blinded to group allocation. The statistical analysis will be performed by a statistician blinded to group allocation.
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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 |
| View source |
| Asthma Patients' and Physicians' Perspectives on the Burden and Management of Asthma. | View source |
| Asthmatic Patients' Poor Awareness of Inadequate Disease Control: A Pharmacy-Based Survey. | View source |
| Prevalence, Risk Factors, and Management of Asthma in China: A National Cross-Sectional Study. | View source |
| Positive Change in Asthma Control Using Therapeutic Patient Education in Severe Uncontrolled Asthma: A One-Year Prospective Study. | View source |
| Economic Evidence for US Asthma Self-Management Education and Home-Based Interventions. | View source |