Vaccinations and People With Disabilities

NCT05749419 | Recruiting

• 1 other identifier: Tenenbaum-HMO-CTIL
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about vaccinations hesitancy, delay or avoidance in children with chronic diseases, congenital anomalies or disabilities. The main questions it aims to answer are: • Attitudes of caregivers towards vaccinating their children, obstacles that postpone vaccinations, and the status of vaccinations of these children. Participants will fill out questionnaires and some will be included in focused groups for the qualitative part of the study. Researchers will compare the vaccinations status of the research group to their siblings' status as well as the published national records of vaccination compliance.

Conditions

Vaccine Refusal; Compliance, Patient; Disability, Intellectual; Congenital Disorders; Pediatric Disorder

Outcome Measures

Primary Outcomes (1)

• Percentages of children in the study group who are not vaccinated, partially vaccinated, or vaccinated late, in comparison with the percentages in the control group.

  Percecntages as described above as well as description of reasons for vaccination avoidance, delay and hesitancy, obstacles in the way to vaccinate, approach to vaccines as detaled in the questionnaires.

  2 years

Study Arms (1)

study group and control group

Study group - children with chronic diseases, disabilities, or congenital anomalies. Control group - their siblings.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Children with disabilities, chronic conditions and congenital anomalies. The parents will fiil out the questionnaires and participate in focus groups.

You may qualify if:

• Diagnosed children with disabilities, chronic diseases or congenital anomalies

You may not qualify if:

• Undiagnosed children
• Inadequate filled out questionnaires

Sponsors & Collaborators

• Hadassah Medical Organization: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Hadassah medical center

Jerusalem, 92140, Israel

RECRUITING

MeSH Terms

Conditions

Vaccination Refusal; Patient Compliance; Intellectual Disability; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Condition Hierarchy (Ancestors)

Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior; Patient Acceptance of Health Care; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Ariel Tenenbaum, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ariel Tenenbaum, MD

CONTACT

+9720508573725; tene@hadassah.org.il

Hadas Lemberg, PhD

CONTACT

00 972 2 6777572; lhadas@hadassah.org.il

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, MD, Clinical Professor, Director of the center for children with chronic diseases

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: March 1, 2023
• Study Start: July 1, 2023
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: April 3, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)