Back to resultsIn-patient Asthma Counseling by Pulmonologist and Hospital Re-admission Rate
Primary Purpose
Asthma
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intensive counseling
Sponsored by
About this trial
This is an interventional prevention trial for Asthma
Eligibility Criteria
Inclusion Criteria:
- Males and females ≥ 18 years old.
- Admitted to Internal Medicine at Soroka University Medical Center due to asthma exacerbation.
Exclusion Criteria:
- Substance abuse (except for tobacco).
- Handicapped or bed ridden patients.
- Patients who don't speak Hebrew, English, Russian or Arabic.
- Other significant respiratory disease such as COPD, interstitial lung disease (as decided by the PI).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intensive counseling by a pulmonologist
Usual care
Arm Description
Counselor visit during hospitalization, telephone follow up for 4 weeks and a follow up visits.
Outcomes
Primary Outcome Measures
Re-admission rate
Secondary Outcome Measures
Full Information
NCT ID
NCT02718339
First Posted
March 20, 2016
Last Updated
March 20, 2016
Sponsor
Soroka University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02718339
Brief Title
In-patient Asthma Counseling by Pulmonologist and Hospital Re-admission Rate
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Soroka University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Prospective randomized clinical trial to assess the effect of in-hospital intensive counseling and follow-up vs. usual care, on re-admission rates of patients with Asthma.
The study population will include asthma patients admitted to internal Medicine departments and medical ICU at Soroka University Medical Center, due to asthma exacerbation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
164 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intensive counseling by a pulmonologist
Arm Type
Experimental
Arm Description
Counselor visit during hospitalization, telephone follow up for 4 weeks and a follow up visits.
Arm Title
Usual care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Intensive counseling
Primary Outcome Measure Information:
Title
Re-admission rate
Time Frame
Within 6 months after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and females ≥ 18 years old.
Admitted to Internal Medicine at Soroka University Medical Center due to asthma exacerbation.
Exclusion Criteria:
Substance abuse (except for tobacco).
Handicapped or bed ridden patients.
Patients who don't speak Hebrew, English, Russian or Arabic.
Other significant respiratory disease such as COPD, interstitial lung disease (as decided by the PI).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nimrod Maimon, MD
Phone
972-8-6403417
12. IPD Sharing Statement
Learn more about this trial
In-patient Asthma Counseling by Pulmonologist and Hospital Re-admission Rate
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