Epididymis Protein 4 and Pulmonary Function With Quality Improvement Protocol Among Cystic Fibrosis Patients
Serum Human Epididymis Protein 4 and Pulmonary Function Before and After Structural Quality Improvement Protocol Among Cystic Fibrosis Patients
Study Overview
Status
Conditions
Detailed Description
This study will be conducted on 35 children diagnosed with cystic fibrosis, aged between 6 and 18 years. Patients will be selected during their follow-up visits to the Pediatric Chest Clinic at Ain Shams University Hospital.
Inclusion Criteria:
A. Pediatric cystic fibrosis patients diagnosed based on the Consensus Guidelines from the Cystic Fibrosis Foundation, with a positive sweat chloride test (≥60 milliequivalent/L) and/or the presence of two cystic fibrosis disease-causing gene mutations.
B. Age ≥6 years. C. Forced expiratory volume in 1st second (FEV₁) ≤80%.
Exclusion Criteria:
A. Patients unable to perform spirometry.
All subjects in the study will undergo an interventional quality improvement plan.
A specialized clinic for CF patients will be established based on the quality improvement (QI) plan, where patients will be followed up every three months by a specialized multidisciplinary team, including a pediatric pulmonologist, pediatric nutrition consultant, pediatric gastroenterologist, chest physiotherapist, and pediatric endocrinologist.
Each specialized clinic will develop and implement standardized cystic fibrosis care algorithms and individualized treatment plans for each patient. These algorithms and plans will be continuously adjusted based on challenges encountered during follow-up to address barriers and deficiencies that may contribute to poor outcomes.
Areas needing improvement will be identified, and appropriate resources and strategies will be proposed. This will include the development of fishbone diagrams, flowcharts, Plan-Do-Study-Act (PDSA) cycles, PDSA ramps, and other quality improvement tools to address specific deficiencies. Additionally, training and engaging the team in quality improvement methodologies will be conducted.
Patients will undergo pulmonary function tests at baseline, followed by assessments at six months and one year during the study.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Eman Fawzy, MD
- Phone Number: Egypt: 201011778583
- Email: eman199358@gmail.com
Study Contact Backup
- Name: Terez Boshra
- Phone Number: +201224035744
- Email: Terezboshra@gmail.com
Study Locations
-
-
Abbasia
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Cairo, Abbasia, Egypt, 00202
- Recruiting
- Ain Shams University
-
Contact:
- Ain Shams university Ain Shams university, MD
- Phone Number: 01011778583
- Email: EMANABDELNAEEM@MED.ASU.EDU.EG
-
Contact:
- Eman Fawzy, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Pediatric CF patients diagnosed based on the Consensus Guidelines from the Cystic Fibrosis Foundation, with a positive sweat chloride test (≥60 milliequivalent/L) and/or the presence of two CF disease-causing gene mutations.
- Age ≥6 years.
- Forced expiratory volume in 1 second (FEV₁) ≤80%.
Exclusion Criteria:
●Patients are unable to perform spirometry.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Pediatric CF patients aged 6 years and above with an FEV₁% predicted below 80%.
Using quality improvement principles for patient care and reassessing after one year.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality Improvement Protocol for Achieving a 5% Increase in FEV₁% Predicted Value in CF Patients"
Time Frame: 12 months
|
Implementation of a quality improvement protocol to achieve a 5% increase in the FEV₁% predicted value in cystic fibrosis patients with impaired pulmonary function.
Pulmonary function will be assessed using spirometry at baseline, six months, and 12 months.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum HE4 Levels Before and After Pulmonary Function Improvement
Time Frame: 12 months
|
Measurement of HE4 levels in the serum of studied subjects before and after pulmonary function improvement.
HE4 levels will be assessed using a standardized laboratory assay at baseline and after 12 months.
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eman Fawzy, Ain Shams University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMASU MD267/2024
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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