Barriers to Patients' Early Presentation, Diagnosis and Treatment in Childhood Hydrocephalus

Hydrocephalus in Children Clinical Trial

Official title:

A Quantitative and Qualitative Analysis of the Barriers to Patients' Early Presentation, Diagnosis and Treatment in Childhood Hydrocephalus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05796713
• Other study ID #: 2023/Hydro
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: January 27, 2024

Study information

• Verified date: January 2024
• Source: Lagos State University
• Contact: Olufemi Idowu, FWACS, FACS
• Phone: 08023451369
• Email: oeidowu412[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 27, 2024
• Est. primary completion date: January 27, 2024
• Gender: All
• Age group: N/A to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Hydrocephalus
• Hydrocephalus in Children

Intervention

Other:
• Hydrocephalus
Interview

Locations

Country	Name	City	State
Nigeria	Lagos State University Teaching Hospital	Ikeja	Lagos

Sponsors (2)

Lead Sponsor	Collaborator
Lagos State University	Hydrocephalus Association

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Presentation time in days	Time in days, from the onset of symptoms to the time the patient seeks medical advice.	14 days
Primary	Diagnostic delay in days	Time in days between the patient's presentation and the confirmation of the diagnosis, in days	14 days
Primary	Treatment delay in days	The duration (in days) between the diagnosis and initiation of treatment	14 days
Secondary	Treatment outcome as perceived by parents/caregivers	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
Secondary	Parents/caregivers satisfaction	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
Secondary	Reason for delay in presentation, diagnosis and treatment	As described by the parents and hospital staff	4 weeks