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

Sponsor
Lagos State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05796713
Collaborator
Hydrocephalus Association (Other)
90
1
10
9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Hydrocephalus

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 Design

Study Type:
Observational
Anticipated Enrollment :
90 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
A Quantitative and Qualitative Analysis of the Barriers to Patients' Early Presentation, Diagnosis and Treatment in Childhood Hydrocephalus
Actual Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Oct 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Outcome Measures

Primary Outcome Measures

  1. Patient Presentation time in days [14 days]

    Time in days, from the onset of symptoms to the time the patient seeks medical advice.

  2. Diagnostic delay in days [14 days]

    Time in days between the patient's presentation and the confirmation of the diagnosis, in days

  3. Treatment delay in days [14 days]

    The duration (in days) between the diagnosis and initiation of treatment

Secondary Outcome Measures

  1. Treatment outcome as perceived by parents/caregivers [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)

  2. Parents/caregivers satisfaction [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)

  3. Reason for delay in presentation, diagnosis and treatment [4 weeks]

    As described by the parents and hospital staff

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 5 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lagos State University Teaching Hospital Ikeja Lagos Nigeria 20001

Sponsors and Collaborators

  • Lagos State University
  • Hydrocephalus Association

Investigators

  • Principal Investigator: Olufemi Idowu, FWACS, FACS, Lagos State University Teaching Hospital, Ikeja, Lagos, Nigeria

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Olufemi Idowu, Professor, Lagos State University
ClinicalTrials.gov Identifier:
NCT05796713
Other Study ID Numbers:
  • 2023/Hydro
First Posted:
Apr 3, 2023
Last Update Posted:
Apr 5, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 5, 2023