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临床试验/NCT05485441
NCT05485441招募中不适用

The Community Nurse as a Public Health Determinant: a Quasi-experimental and Interventional Study of Promotion of Papillomavirus Vaccination in the School Population

University of Bari Aldo Moro2 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2023年2月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
800
试验地点
2
主要终点
Children's vaccination uptake

研究概览

简要总结

To date, there have been no interventional studies aimed at increasing HPV vaccination rates by making use of digital and involving all stakeholders within this process: nurses, physicians, caregivers, parents, and children/adolescents according to the PPI principle.

The primary objective of the project is to identify the effectiveness of a digital educational intervention, conducted by a multidisciplinary healthcare team and targeting adolescents of both sexes in secondary schools. The outcome measures will be: engagement, increased knowledge and self-efficacy, and vaccination uptake.

This project will identify new models for addressing public health needs. The secondary aim is to evaluate parents' attitudes toward vaccination pre- and post-intervention education.

A quasi-experimental, pre-post educational intervention study will be conducted by adopting a convenience sampling will be adopted at secondary schools in Bari (Puglia, Italy).

详细描述

The study will be carried out in a multiphasic mode. All steps are described below.

  • First Phase (T0): the Community Nurses (CN) will send, via e-mail to all parents, a questionnaire aimed at investigating their children's vaccination status, hesitation to vaccination, sources of information, and information needs about vaccination. Then, upon prior arrangement with the school Principal, the CN will, in-person, distribute a questionnaire to all participating students to explore adolescents' knowledge about HPV vaccination, their involvement in vaccine decision-making, their feelings, and perceived self-efficacy.
  • Second Phase (T1): the CN, after analyzing all the responses from the questionnaires administered to both parents (to investigate hesitations to vaccination) and students (on students' knowledge, involvement, feelings, self-efficacy), will set up an educational intervention, involving the members of expert (nurses and physicians' experts in public health).

Description of the educational intervention

The educational intervention will be provided (at T1) in two ways:

(I) a video lecture in e-learning mode lasting about an hour, aimed at adolescents, using the School Institute's platform for distance education, using audiovisual systems and slide presentations in Power Point format; learner-learner interactions will be possible through e-mail messages, real-time individual chats and asynchronous discussion forum conversations including comment sections.. The event will be recorded so that both adolescents and parents can access it at their convenience.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
11 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Students aged 11- 13 years and their parents.
  • Students with disabilities, with visual and hearing impairment, with the suppor of their support teacher.

排除标准

  • Students and/or parents who do not agree to participate
  • Students and/or parents who do not provide informed consent
  • Students and/or parents who do not provide a telephone number and e-mail address to be contacted

结局指标

主要结局

Children's vaccination uptake

时间窗: 90 days

Measured through a telephonic interview to parents, difference in vaccination rates (% before/after)

Children's knowledge on HPV vaccination

时间窗: 90

Measured through: (1) the Questionnaire - HAVIQ Adolescente Vaccine Intervention Questionnaire; 5-point Likert scale (from 1=strongly disagree to 5=strongly agree). (2) 10 items with dichotomous "yes/no" responses. Each correct answer will be assigned a score of 1, each answer not given or incorrect, zero. The total score ranges from 0 (no knowledge) to 10 (highest level of knowledge).

Children's self-efficacy in receiving the vaccine

时间窗: 90

Measured through the Questionnaire - HAVIQ Adolescente Vaccine Intervention Questionnaire; 100-point scale (0="not at all confident"; 100="completely confident").

Children's fear and anxiety towards vaccination

时间窗: 90

Measured through the Questionnaire - HAVIQ Adolescente Vaccine Intervention Questionnaire; 5-point Likert scale (from 1=strongly disagree to 5=strongly agree)

Children's involvement in vaccine decision making

时间窗: 90

Measured through the Questionnaire - HAVIQ Adolescente Vaccine Intervention Questionnaire; 5-point Likert scale (from 1=strongly disagree to 5=strongly agree)

次要结局

  • Parent's hesitancy about vaccination(90 days)

研究者

发起方
University of Bari Aldo Moro
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pasquale Stefanizzi

Assistant Professor

University of Bari Aldo Moro

研究点 (2)

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