Impact of Vaccine Education Program on Vaccine Advocacy and Vaccine Literacy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Vaccine Education Program Based on The Integrated Change Model on Vaccine Advocacy and Vaccine Literacy: A Waitlist Randomized Controlled Trial

Conditions
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Unrecognized Condition

Intervention / Treatment
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* Other: Vaccine Education Program Based on Integrated Change Model


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization and blinding are recommended in randomized controlled studies to prevent biases and show the experiment's success (15). Allocation: Random assignment. Block randomization will be used in the randomization process. Randomizer.org will be used to select block combinations with eight blocks. Eligible participants will be randomly assigned to the intervention or waitlist group using the permuted block randomization method on a 1:1 basis. The waiting list group will form the second set of the research, which is planned to be attempted two months later. The participant assignment list will be generated by a non-research statistician with a random distribution sequence. Assignment confidentiality will be ensured using opaque sealed envelopes containing sequence numbers. The data analyst/statistician will be blind to the participants' group assignments.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Experiment: The Vaccine Education Program based on The Integrated Change Model will be administered to the mothers in the experimental group by the researcher. The training will take place in four sessions, one week apart, and each session will last approximately 45 minutes. The training will be carried out as group training with 4-5 people. Data collection forms will be applied before and after the program. | Other: Vaccine Education Program Based on Integrated Change Model<br>* Vaccine Education Program Based on Integrated Change Model The training will take place in four sessions, one week apart, and each session will last approximately 45 minutes. The training will be carried out as group training with 4-5 people.<br>|
| Other: Control-waiting list<br>Control (waiting list): The control group of the study will be the mothers who are on the waiting list. No intervention will be made to the mothers in the control group during the education process of the experimental group. After the training process of the mothers in the experimental group is completed and the post-test data are collected, all the interventions and training will be given to the mothers in the control group. | Other: Vaccine Education Program Based on Integrated Change Model<br>* Vaccine Education Program Based on Integrated Change Model The training will take place in four sessions, one week apart, and each session will last approximately 45 minutes. The training will be carried out as group training with 4-5 people.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaccine literacy | 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). | 01.08.2023-31.08.2023 (within 1 month on average) | 
| Vaccine advocacy intention | 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). | 01.08.2023-31.08.2023 (within 1 month on average) | 
| vaccine attitudes | 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). | 01.08.2023-31.08.2023 (within 1 month on average) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaccine knowledge level and sources of vaccine information | The secondary result expected from the study is the change in mothers' knowledge of vaccination and sources of vaccination information. Vaccine knowledge: Vaccine Knowledge Test Vaccine Knowledge Test: Researchers conducted Vaccine Knowledge Test by reviewing the literature to evaluate mothers' knowledge about vaccines has been prepared (5-10). In the Vaccine Knowledge Test, there are 31 questions answered as true, false, and do not know. Expert opinion was taken while creating the Vaccine Knowledge Test, and the content validity was evaluated. The lowest score that can be obtained from the Vaccine Knowledge Test is 0, and the highest score is 31; The increase in the total score indicates that the vaccination knowledge is high. The results will be evaluated for each participant before and after the vaccine training (within 1 month on average). | 01.08.2023-31.08.2023 (within 1 month on average) | 
| Sources of vaccine information | Vaccine Information Resources: Vaccine Knowledge Resources Questionnaire Vaccine Knowledge Resources Questionnaire: Vaccine information resources of mothers will be evaluated with the Vaccine Information Resources Questionnaire. The researchers reviewed the Vaccine Information Resources Questionnaires to determine which sources mothers used as vaccine information sources in the literature (1, 11-14). There are eight questions in this form; The questions are answered with yes or no. After the training, mothers are expected to obtain information from reliable information sources such as WHO and UNICEF. The results will be evaluated for each participant before and after the vaccine training (within 1 month on average). | 01.08.2023-31.08.2023 (within 1 month on average) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccines, Immunization, Literacy, Health Literacy