Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06201728
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-14
First Post:
2024-01-01
Brief Title:
The Effect of Asthma Flare-up Clinic After Exacerbation
Sponsor:
Tel-Aviv Sourasky Medical Center
Organization:
Tel-Aviv Sourasky Medical Center
Study Overview
Official Title:
The Role of Asthma Flare-up Clinic in Improving Management and Outcomes of Asthma
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this interventional study is to examine the effect of asthma flare-up clinic follow-up in adult subjects after an asthma flare-up This study aim to answer the following questions
1 Does a follow-up in a flare-up clinic improves disease outcomes
2 Does a follow-up in a flare-up clinic improves disease management
Participants in the intervention group will take part in a structured follow-up at the asthma flare-up clinic at three time points Each visit will include questionnaires pulmonologist examination and consultation laboratory tests and spirometry The control group will undergo phone-call follow-up with a research coordinator in similar time frames as the intervention
Researchers will compare the two groups to see if the clinic follow-up affects the study outcomes
1 Does a follow-up in a flare-up clinic improves disease outcomes
2 Does a follow-up in a flare-up clinic improves disease management
Participants in the intervention group will take part in a structured follow-up at the asthma flare-up clinic at three time points Each visit will include questionnaires pulmonologist examination and consultation laboratory tests and spirometry The control group will undergo phone-call follow-up with a research coordinator in similar time frames as the intervention
Researchers will compare the two groups to see if the clinic follow-up affects the study outcomes
Detailed Description:
The primary outcomes will be analyzed as total exacerbations during the time frame and as a time-dependent variable time to exacerbation using Kaplan Meier survival analysis Additional sub-analyses will be made for the type of inclusion setting EDhospitalization number of prior exacerbations and eosinophil count Additional analyses will be made for all secondary outcomes Analyses relevant only for the intervention group such as spirometry and IOS will compare results to the first follow-up visit A cost-effectiveness analysis will be made comparing the follow-up cost and the cost saved by exacerbation reduction based on the final results
Sample size calculation - The invetigators assume based on previous research that the intervention will lead to a 20 decrease in exacerbations during the 18 months from first follow-up To achieve an alpha of 005 and a power of 80 there is a need for 88 patients in each group Assuming a loss-to-follow-up rate missing to complete at least 2 clinic visits or loss to phone follow-up of 20 the study will need 115 patients in each group 230 overall
Sample size calculation - The invetigators assume based on previous research that the intervention will lead to a 20 decrease in exacerbations during the 18 months from first follow-up To achieve an alpha of 005 and a power of 80 there is a need for 88 patients in each group Assuming a loss-to-follow-up rate missing to complete at least 2 clinic visits or loss to phone follow-up of 20 the study will need 115 patients in each group 230 overall
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None