Post Splenectomy Care Assessment and the Role of Patient Education in Its Improvement

NCT07027371 | Completed DMC

• 1 other identifier: MS-486-2021
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this trial is to evaluate compliance to booster vaccines and chemoprophylaxis in children who underwent a splenectomy and to assess the knowledge regarding this aspect before and after giving education.

Conditions

Splenectomized Patients

Keywords

Overwhelming post splenectomy infections; splenectomy; chemoprophylaxis; vaccination; encapsulated organisms

Outcome Measures

Primary Outcomes (1)

• Candidates' knowledge about the different aspects of post splenectomy hazards and methods of care

  A questionnaire designed by the hematology team inquiring about different aspects of post splenectomy hazards and methods of care was handed to candidates. Each correct answer was given a score of 1. A score was summed up and a total score (as a percentage of correct answers) was given.

  At baseline and immediately after intervention

Secondary Outcomes (2)

• To detect the rate of vaccination (defined as the percentage of people who have received vaccines) to pneumococcal, meningococcal and hemophilus influenza vaccine among the studied population (splenectomized patients).

  At time of enrollment in the study

• To detect the percentage of patients who received post splenectomy chemoprophylaxis among the studied population.

  At time of enrollment in the study

Study Arms (1)

Interventional group

EXPERIMENTAL

Splenectomized patients above 15 years and caregivers of patients below 15 years received a questionnaire that included questions enquiring about age, gender, education level, disease type, duration of illness, age at splenectomy, duration since splenectomy, reception of preoperative vaccines, compliance to post splenectomy booster doses and penicillin prophylaxis, and the reasons for non-compliance if any, and their perception regarding red flags of Overwhelming Post Splenectomy Infection "OPSI". Based on the gaps of care identified in the essential questionnaire, educational material about perisplenectomy care was obtained. A knowledge test and a printed brochure were designed based on the knowledge script. Candidates who agreed to complete the study were asked to fill in individually the pre-education knowledge test. The brochures were then handed to each patient or caregiver. Participants were encouraged to read the brochure. Then they completed the post-education knowledge test

Behavioral: Health education

Interventions

Health education BEHAVIORAL

Health education was given in the form of a printed colored brochure designed in easy-to-understand Arabic language. Participants were encouraged to read the brochure thoroughly and as many times as needed and to ask questions to the researchers if they had any.

Interventional group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients above 15 years who had undergone splenectomy
• Caregivers of patients aged below 15 years who had undergone splenectomy

You may not qualify if:

• Illiterate candidates
• Candidates who refuse to take part in the study

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Department of Pediatrics, Faculty of Medicine, Cairo University

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 18, 2025
• Study Start: December 15, 2021
• Primary Completion: December 18, 2022
• Study Completion: July 7, 2023
• Last Updated: June 18, 2025

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)