Impact of Vaccine Education Program on Vaccine Advocacy and Vaccine Literacy

Unrecognized Condition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05929053
• Other study ID #: ArtvinCoruhU
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: June 2023
• Source: Artvin Coruh University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 74
• Est. completion date: September 30, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

Inclusion criteria for the mother

1. To be residing in Artvin city center

2. To have applied to the Family Health Center No. 1 or 2 in the city center for any reason.

3. Having at least a high school graduate education level

4. Having a child in the age range that covers the national vaccination calendar (0-13 years old)

5. Turkish - speaking

6. Being literate

7. Being 18 years or older

8. Volunteering to participate in research

Exclusion Criteria:

Exclusion criteria for the mother

1. To reside outside of Artvin city center

2. To have an education level below a high school graduate

3. Having a child not between 0-13 years old

4. Not know to speak Turkish

5. Not volunteering for research

Related Conditions & MeSH terms

• Unrecognized Condition

Intervention

Other:
• Vaccine Education Program Based on Integrated Change Model
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.

Locations

Country	Name	City	State
Turkey	Deniz S. Sümeyye YORULMAZ	Merkez	Artvin

Sponsors (1)

Lead Sponsor	Collaborator
Artvin Coruh University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)

External Links

•   Aharony N, Goldman R, (2017). E-health literacy and the vaccination dilemma: an Israeli perspective. Information Research, 22(2), paper 751.
•   Akin B, & Koçoglu, D. (2017). Randomize kontrollü deneyler. Hacettepe Üniversitesi Hemsirelik Fakültesi Dergisi, 4(1), 73-92.
•   Aygün E, Tortop HS, 2020. Ebeveynlerin asi tereddüt düzeylerinin ve karsitlik nedenlerinin incelenmesi. Güncel Pediatri, 18(3), 300-16.
•   Hasar M, Özer ZY, Bozdemir N, 2021. Asi reddi nedenleri ve asilar hakkindaki görüsler. Cukurova Medical Journal, 46(1), 166-76.
•   Olson O, Berry C, Kumar N, (2020). Addressing parental vaccine hesitancy towards childhood vaccines in the United States: a systematic literature review of communication interventions and strategies. Vaccines, 8(4), 590.
•   Rizzi M, Attwell K, Casigliani V, Taylor J, Quattrone F, Lopalco P, 2021. Legitimising a 'zombie idea': childhood vaccines and autism-the complex tale of two judgments on vaccine injury in Italy. International Journal of Law in Context, 1-21.
•   Yorulmaz, D. S., & Kocoglu-Tanyer, D. (2023). A vaccine literacy scale for childhood vaccines: Turkish validity and reliability vaccine literacy scale. Journal of Public Health, 1-9.