Clinical trial NCT05929053: Impact of Vaccine Education Program on Vaccine Advocacy and Vaccine Literacy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unrecognized Condition
Keywords: Vaccines
Immunization
Literacy
Health Literacy
Lead sponsor: Artvin Coruh University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Vaccine literacy
timeFrame: 01.08.2023-31.08.2023 (within 1 month on average)
measure: Vaccine advocacy intention
timeFrame: 01.08.2023-31.08.2023 (within 1 month on average)
measure: vaccine attitudes
timeFrame: 01.08.2023-31.08.2023 (within 1 month on average)
Secondary outcomes:
measure: Vaccine knowledge level and sources of vaccine information
timeFrame: 01.08.2023-31.08.2023 (within 1 month on average)
measure: Sources of vaccine information
timeFrame: 01.08.2023-31.08.2023 (within 1 month on average)
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: Deniz S. Sümeyye YORULMAZ
state: Artvin
Study officials:
References: