Impact of Vaccine Education Program on Vaccine Advocacy and Vaccine Literacy

NCT05929053 | Completed

• 1 other identifier: ArtvinCoruhU
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Unrecognized Condition

Keywords

Vaccines; Immunization; Literacy; Health Literacy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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)

Study Arms (2)

Experimental

EXPERIMENTAL

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

Control-waiting list

OTHER

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

Interventions

Vaccine Education Program Based on Integrated Change Model OTHER

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.

Control-waiting list; Experimental

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Mothers with 0-13-year-old children
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Artvin Coruh University: lead

Study Sites (1)

Deniz S. Sümeyye YORULMAZ

Merkez, Artvin, 08000, Turkey (Türkiye)

Location

Related Publications (1)

• Yorulmaz-Demir DS, Kocoglu-Tanyer D. The Effect of the Vaccine Education Program Prepared Using The Integrated Change Model on Mothers' Vaccine Advocacy and Vaccine Literacy: A Waitinglist Randomized Controlled Trial. J Pediatr Health Care. 2025 May-Jun;39(3):424-435. doi: 10.1016/j.pedhc.2024.11.012. Epub 2025 Feb 1.

  PMID: 39891641 DERIVED

Related Links

• 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.
• Aharony N, Goldman R, (2017). E-health literacy and the vaccination dilemma: an Israeli perspective. Information Research, 22(2), paper 751.
• Aygün E, Tortop HS, 2020. Ebeveynlerin aşı tereddüt düzeylerinin ve karşıtlık nedenlerinin incelenmesi. Güncel Pediatri, 18(3), 300-16.
• 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.
• Hasar M, Özer ZY, Bozdemir N, 2021. Aşı reddi nedenleri ve aşılar hakkındaki görüşler. Cukurova Medical Journal, 46(1), 166-76.
• Akın B, \& Koçoğlu, D. (2017). Randomize kontrollü deneyler. Hacettepe Üniversitesi Hemşirelik Fakültesi Dergisi, 4(1), 73-92.

MeSH Terms

Conditions

Literacy

Condition Hierarchy (Ancestors)

Communication; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: July 3, 2023
• Study Start: July 3, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)