Clinical trial NCT05796713: Barriers to Patients' Early Presentation, Diagnosis and Treatment in Childhood Hydrocephalus
Official title: A Quantitative and Qualitative Analysis of the Barriers to Patients' Early Presentation, Diagnosis and Treatment in Childhood Hydrocephalus
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hydrocephalus in Children
Lead sponsor: Lagos State University
Sponsor class: OTHER
Collaborators: name: Hydrocephalus Association
First posted: 2023-04-03
Enrollment: 90
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who present at the Lagos State University Teaching Hospital, Ikeja, Lagos for management of hydrocephalus

Brief summary: Patient with childhood hydrocephalus (HC) tend to present late in Low medium income countries (LMICs). This project will study the barriers leading to patients' and health system delay in patients with childhood HC. This will be done via a quantitative and qualitative study analysis. The data will be collected prospectively.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Presentation time in days
timeFrame: 14 days
measure: Diagnostic delay in days
timeFrame: 14 days
measure: Treatment delay in days
timeFrame: 14 days
Secondary outcomes:
measure: Treatment outcome as perceived by parents/caregivers
timeFrame: 4 weeks
measure: Parents/caregivers satisfaction
timeFrame: 4 weeks
measure: Reason for delay in presentation, diagnosis and treatment
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Ikeja
country: Nigeria
facility: Lagos State University Teaching Hospital
state: Lagos
Study officials:
affiliation: Lagos State University Teaching Hospital, Ikeja, Lagos, Nigeria
name: Olufemi Idowu, FWACS, FACS
role: PRINCIPAL_INVESTIGATOR
References: