COVID-19 Vaccination Willingness in Older Adults Based on Self-determination Theory
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Willingness to vaccinate
研究概览
简要总结
Introduction: The COVID-19 vaccine is an effective measure for preventing and controlling COVID-19 epidemics, and the World Health Organization lists older adults as a high-priority group for COVID-19 vaccination. However, the willingness of older people to be vaccinated against COVID-19 remains an important issue in achieving herd immunity. We investigated the effectiveness of a COVID-19 vaccine intervention for older adults, based on self-determination theory.
Methods and analysis: Questionnaires were administered to assess vaccine willingness at baseline and at 6 weeks following educational intervention programs concerning vaccination against COVID-19. Four nursing homes with a population size of over 100 will be selected and randomized into intervention and control groups. The control group will undergo conventional intervention methods, and the intervention group will undergo a comprehensive intervention program based on self-determination theory.
Ethics and dissemination: The study has been approved by the Ethics Committee of Taizhou Hospital, Zhejiang Province, China (approval number: K20230832).
详细描述
- Study design and data collection This class pilot study will be conducted in September 2023 at a nursing home in Taizhou, China. This study has been approved by the Ethics Committee of Taizhou Hospital, Zhejiang Province, China (approval number: K20230832). All procedures will be performed in accordance with the guidelines of our institutional ethics committee and in compliance with the Declaration of Helsinki. The respondents' information will remain anonymous.
- Patients and public involvement The study participants will be not involved in the design, implementation, or reporting of the study.
2.1 Recruitment 2.2.1 Inclusion criteria
- 60 years old or above
- Have not been vaccinated for COVID-19 or have not completed the fourth booster shot of the COVID-19 vaccine
- Able to communication and willing to participate in the survey voluntarily 2.2.2 Exclusion criteria
(1) People with contraindications to vaccination (2) People with communication disorders (3) Those who do not want to participate in the survey 2.3.3 Grouping of study participants We will select four senior care institutions in Taizhou City with a population of 100 or more residents. We will divide them into intervention and control groups.
2.4 Sample size The sample size was determined using G*Power software v3.1.9.2 (Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany). It will be estimated for repeated measures between the two groups at a significance level of 0.05, effect size of 0.19, and power of 95%. The final calculated sample size is 182 participants. Assuming a 10% attrition rate over the course of the intervention, we set a target of recruiting 200 participants. Based on the number of repeated measurements, this represented 100 participants in each group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(1) ≥ 60 years of age; (2) had not previously been vaccinated with a COVID-19 vaccine, or had not yet received their fourth booster dose of the vaccine; and (3) had the ability to communicate verbally and volunteered to participate in the survey.
排除标准
- •(1) contraindications to vaccination; (2) communication disorders; and (3) unwillingness to participate.
结局指标
主要结局
Willingness to vaccinate
时间窗: 6 weeks
Changes in Vaccination Wiilingness Scores for the Elderly
次要结局
- Basic psychological needs(6 weeks)
- Vaccine literacy(6 weeks)
研究者
Jing-Shan Deng
Main responsibility and supervision
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University