- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05796713
Barriers to Patients' Early Presentation, Diagnosis and Treatment in Childhood Hydrocephalus
A Quantitative and Qualitative Analysis of the Barriers to Patients' Early Presentation, Diagnosis and Treatment in Childhood Hydrocephalus
Study Overview
Detailed Description
Children less than 5 years of age with HC confirmed with either magnetic resonance or computerized tomographic images will be recruited. In addition, Hospital staff members, who have been working within the Neurosurgical unit for at least 5 years will be interviewed.
The patients' data that will be collected will include gender, age at presentation, socioeconomic class of parents (or guardians), religion, referral source, presenting complaint with its duration, physical findings, ventricular diameter. The Pre-presentation symptoms interval (PPI) will be defined as the number of days between the onset of symptoms and first presentation at any type of healthcare service centre (including primary healthcare centre, secondary health institutions); Presentation Interval (PI)- Number of days from symptoms to presenting at Neurosurgical centre; Pre-diagnostic interval (PDI) will be defined as the interval in days between symptoms and completion of pre-operative investigations. Patient interval (PI) will be defined as the number of days from the onset of symptoms and patient's first contact with the Neurosurgical center. Hospital interval (HI)- number of days from completion of investigations to surgical intervention. The collected data will be analyzed according to qualitative conventional content analysis. Nvivo software version 13 and Statistical Product and Service Solutions (SPSS) version 23 will be used for data analysis.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Lagos
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Ikeja, Lagos, Nigeria, 20001
- Lagos State University Teaching Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients less than 5 years of age with HC confirmed with either magnetic resonance or computerized tomographic images
- Patients' parents' inclusion criteria will be parents (Guardians) of children with radiologically confirmed HC with either magnetic resonance or computerized tomographic images.
- Hospital staff members, who have been working within the Neurosurgical unit for at least 5 years.
Exclusion Criteria:
- All patents not investigated or operated at our centre
- Patients older than 5 years
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Presentation time in days
Time Frame: 14 days
|
Time in days, from the onset of symptoms to the time the patient seeks medical advice.
|
14 days
|
|
Diagnostic delay in days
Time Frame: 14 days
|
Time in days between the patient's presentation and the confirmation of the diagnosis, in days
|
14 days
|
|
Treatment delay in days
Time Frame: 14 days
|
The duration (in days) between the diagnosis and initiation of treatment
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment outcome as perceived by parents/caregivers
Time Frame: 4 weeks
|
Effectiveness of the treatment in improving patient outcomes using a questionnaire (5-point Likert scale based survey questions with higher scores meaning better outcome)
|
4 weeks
|
|
Parents/caregivers satisfaction
Time Frame: 4 weeks
|
The parent's satisfaction with the quality of care received using a questionnaire (5-point Likert scale based survey questions with higher scores meaning better outcome)
|
4 weeks
|
|
Reason for delay in presentation, diagnosis and treatment
Time Frame: 4 weeks
|
As described by the parents and hospital staff
|
4 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Olufemi Idowu, FWACS, FACS, Lagos State University Teaching Hospital, Ikeja, Lagos, Nigeria
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/Hydro
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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