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临床试验/NCT05749419
NCT05749419招募中不适用

Questionnaires and Focus Groups Based Quantitative & Qualitative Study of Vaccine Hesitancy and Confidence Among At-risk and Marginalized Populations: Persons With Special Needs, Intellectual Disabilities and Congenital Anomalies

Hadassah Medical Organization1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
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.

研究概览

简要总结

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.

详细描述

Global vaccines programs prevent infectious diseases, congenital anomalies and cancer [1,2]. Full and partial avoidance of vaccines, or postponing vaccines, may lead to morbidity, disability and mortality. This is particularly significant among children and adults with special needs, intellectual and developmental disabilities, and congenital anomalies, which are at-risk groups, together representing over 15% of the general population [3,4]. Studies have shown that this population is particularly vulnerable when it comes to infectious diseases, hospitalizations, sexually transmitted diseases, abuse and neglect [5,6,7]. Furthermore, this is a marginalized population, with (in average) a lower socioeconomic status and at a lower level of education of themselves and their caregivers [8]. The reasons for hesitance, avoidance or selectivity of vaccines by the caregivers are not comprehensively characterized. Therefore, the investigators outline our thoughts and Insights from our ongoing work, for over two decades, with this population. In the investigators experience, when doctors and nurses ask the patients and their caregivers what are the reasons for less-then-optimal vaccination state, there are several explanations: concurrent illnesses that made them postpone vaccinations, access challenges, being preoccupied with many other health tasks, and paradoxically the fear that the child is too fragile for receiving the vaccine or that the vaccine itself will do harm. Also, some may be wrongly advised about contraindications that are misinterpreted. It is surprising that the infestigators hear from caregivers about the fear from the vaccines, and not about the fear from the diseases. Another important issue is the unfortunate vulnerability of this population to STD's, which the investigators repeatedly hear from caregivers that this is a non-issue for them, which is clearly a dangerous misconception [9].

Therefore, healthcare professionals are missing valuable information about possible risks and intervention opportunities among an at-risk population.

Objectives:

  1. The investigators will systematically map the reasons for the delay and/or avoidance, and/or hesitance to vaccinate by conducting a large-scale evaluation of current and planned immunizations among persons of all ages who have special needs, intellectual and developmental disabilities and congenital anomalies (study group). The investigatorswill use a comprehensive questionnaire to collect this information, as well as focused discussion groups for in-depth qualitative investigations. The investigators will compare the data with their sibling's vaccination status and with recruits from the general population (control group).

According to the concept "Do not talk about us without us", The investigators will include persons with special needs and disabilities in the study and make all efforts to hear directly from them in focus groups or individually about their approach to vaccinations, including hesitancies and misconceptions about the procedure.

研究设计

研究类型
Observational
观察模型
Family Based
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • Diagnosed children with disabilities, chronic diseases or congenital anomalies

排除标准

  • Undiagnosed children
  • Inadequate filled out questionnaires

结局指标

主要结局

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.

时间窗: 2 years

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tenenbaum Ariel

Principal investigator, MD, Clinical Professor, Director of the center for children with chronic diseases

Hadassah Medical Organization

研究点 (1)

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