The Effect of Vaccine Education Program Based on The Integrated Change Model on Vaccine Advocacy and Vaccine Literacy: A Waitlist Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- vaccine attitudes
研究概览
简要总结
This research will be carried out as a randomized controlled study with a waitlist in parallel design to evaluate the effect of the vaccine education and vaccine advocacy program prepared according to The Integrated Change Model on the level of vaccination literacy and the transformation into vaccine advocates. Research hypothesis "H0a: Vaccine education program prepared according to The Integrated Change Model does not affect vaccine literacy, H0b: The vaccine training program prepared according to the integrated change model does not affect the concepts (information sources, intention, attitude, behavior, obstacles) in the integrated change model determined for vaccine advocacy. At the end of the training, it is thought that the mothers in the experimental group will be different from the control group regarding vaccine literacy and the vaccine advocacy concepts (information sources, intention, attitude, behavior) in the model.
详细描述
This research will be carried out as a randomized controlled study with a waitlist in parallel design to evaluate the effect of the vaccine education and vaccine advocacy program prepared according to The Integrated Change Model on the level of vaccination literacy and the transformation into vaccine advocates. Research hypothesis "H0a: Vaccine education program prepared according to The Integrated Change Model does not affect vaccine literacy, H0b: The vaccine training program prepared according to the integrated change model does not affect the concepts (information sources, intention, attitude, behavior, obstacles) in the integrated change model determined for vaccine advocacy. At the end of the training, it is thought that the mothers in the experimental group will be different from the control group regarding vaccine literacy and the vaccine advocacy concepts (information sources, intention, attitude, behavior) in the model.
A national study on the subject was used in calculating the study's sample size. In a study conducted in Turkey, the rate of those who were hesitant about vaccination in the families of children under five years old and the rate of rejection was found to be 19.8% (1). The sample size required to eliminate this situation with vaccine advocacy was calculated as a total of 64 individuals at 0.05 alpha and 80% power level in the Gpower program. Considering the sample losses, the sample was increased by 15% (9.6 people ~ 10 people), and a total of 74 people, 37 of which were experimental and 37 control, was determined. Mothers who applied to the Family Health Centers, which are research areas, will be evaluated according to the eligibility criteria. Then researcher (DS-Y) will obtain contact information from mothers, who met the inclusion criteria, volunteered for the study, and consented, and collect pre-test. The participants will be divided into experimental and control groups using the blind technique and block randomization. The vaccination training program prepared based on The Integrated Change Model for the mothers in the experimental group will be face-to-face training. The training will be in the form of 4 sessions (with a 1-week interval) as group training for 4-5 people, and each session will last 45 minutes on average. After the training program of the mothers in the experimental group is completed, the data collection forms will be applied again to the mothers in the experimental and control groups. After the last measurement, a 4-session vaccination training program will be applied to the mothers in the control group in the same way and within the same scope as the experimental group.
The primary outcome expected from the study is the change in mothers' vaccine literacy, vaccine advocacy intention, and vaccine attitudes.
The secondary result expected from the study is the change in mothers' knowledge of vaccination and sources of vaccination information.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Single blinding(Participant blinding) will be done; participants will not be told they are in the experimental or control group. The first researcher will invite mothers to the study, which will continue until the targeted sample number(74 participants) is reached. During the participant registration, the names and contact information of the mothers will be obtained; it will be stated that they will be contacted for the training process, that the training time may be extended, and that they will be given definite training. The second researcher in the research team will explain to the first researcher that the participants are in the experimental or control group. The mothers in the control group will be assigned to the waiting list. At the end of the study, a four-session vaccination training program will be applied to the mothers in the control group in the same way and within the same scope as the experimental group.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for the mother
- •To be residing in Artvin city center
- •To have applied to the Family Health Center No. 1 or 2 in the city center for any reason.
- •Having at least a high school graduate education level
- •Having a child in the age range that covers the national vaccination calendar (0-13 years old)
- •Turkish - speaking
- •Being literate
- •Being 18 years or older
- •Volunteering to participate in research
排除标准
- •Exclusion criteria for the mother
- •To reside outside of Artvin city center
- •To have an education level below a high school graduate
- •Having a child not between 0-13 years old
- •Not know to speak Turkish
- •Not volunteering for research
结局指标
主要结局
vaccine attitudes
时间窗: 01.08.2023-31.08.2023 (within 1 month on average)
The Public Attitude Towards Vaccination Scale-Health Belief Model (PAVS-HBM): PAVS-HBM measure the public's attitude towards the vaccine according to the health belief model. The scale consists of 26 items and five sub-dimensions: sensitivity, severity, benefits, barrier, and health responsibility. Each sub-dimension is evaluated separately. Sensitivity and severity sub-dimension has four items (lowest4, highest20 points); benefit and health responsibility sub-dimension consists of five items (lowest5, highest25 points), and the barrier sub-dimension consists of eight items (lowest8, highest40 points). While the decrease in the total score in the disability sub-dimension indicates a positive attitude. An increase in the total score in other sub-dimensions means a positive attitude (4).The results will be evaluated for each participant before and after the vaccine training (within 1 month on average).
Vaccine advocacy intention
时间窗: 01.08.2023-31.08.2023 (within 1 month on average)
Vaccine Advocacy Intention: Vaccine Advocacy Intent Scale Vaccine Advocacy Intention: Vaccine Advocacy Intent Scale Vaccine Advocacy Intent Scale: Mothers' vaccine advocacy intent will be evaluated with the Vaccine Advocacy Intent Scale. Researchers prepared the Vaccine Advocacy Intention Scale to assess mothers' intentions to engage in vaccine advocacy. The scale is scored between 0-10 points; an increase in the total score is interpreted as an increase in vaccine advocacy intention. The aim is to evaluate quantitatively mothers' intentions to be able to do vaccine advocacy. The results will be evaluated for each participant before and after the vaccine training (within 1 month on average).
Vaccine literacy
时间窗: 01.08.2023-31.08.2023 (within 1 month on average)
The primary outcome expected from the study is the change in mothers' vaccine literacy, vaccine advocacy intention, and vaccine attitudes. Vaccine Literacy: Vaccine Literacy Scale Vaccine Literacy Scale: The scale evaluates the level of vaccine literacy. The Vaccine Literacy Scale was developed by Ahoran et al. (2017). The scale consists of 3 sub-dimensions and 13 items: Functional, Communicative, and Critical Health Literacy. The scores of the subscales are calculated separately; therefore, the scale has no total score. Responses in each subscale are divided by the number of items to obtain a score. Lower functional health literacy scores indicate higher health literacy. Higher communicative and critical health literacy scores indicate higher health literacy. The researchers previously carried out this scale's Turkish validity and reliability study (3). The results will be evaluated for each participant before and after the vaccine training (within 1 month on average).
次要结局
- Vaccine knowledge level and sources of vaccine information(01.08.2023-31.08.2023 (within 1 month on average))
- Sources of vaccine information(01.08.2023-31.08.2023 (within 1 month on average))
研究者
Deniz Sümeyye YORULMAZ
Principal Investigator
Artvin Coruh University