Unrecognized ConditionNCT05929053
Impact of Vaccine Education Program on Vaccine Advocacy and Vaccine Literacy
A study testing Vaccine Education Program Based on Integrated Change Model in people with Unrecognized Condition, run by Artvin Coruh University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Unrecognized Condition
- What is being tested?
- Vaccine Education Program Based on Integrated Change Model
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jul 2023to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Deniz S. Sümeyye YORULMAZ
Merkez, Artvin, 08000
About this study
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
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.
Read the 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.
- Conditions
- Unrecognized Condition
- Being tested
- Vaccine Education Program Based on Integrated Change Model
- Keywords
- Vaccines, Immunization, Literacy, Health Literacy
- Medical subject headings
- Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccine Education Program Based on Integrated Change ModelOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Vaccine Education Program Based on Integrated Change Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 01.08.2023-31.08.2023 (within 1 month on average)
Secondary outcomes (2)
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).
Measured: 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).
Measured: 01.08.2023-31.08.2023 (within 1 month on average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start3 Jul 2023
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unrecognized ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artvin Coruh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Sümeyye YORULMAZ, Artvin Coruh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929053
- Sponsor's protocol ID
- ArtvinCoruhU
- Status last verified
- Nov 2024
- First submitted
- 24 Apr 2023
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The personal information of the participants will only be used by the researchers.
Publications
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.
PubMed 39891641
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05929053
- Acronym / sponsor ID
- ArtvinCoruhU
- Conditions
- Unrecognized Condition
- Keywords
- Vaccines, Immunization, Literacy, Health Literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Artvin Coruh UniversityUniversity, hospital or other
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Vaccine Education Program Based on Integrated Change ModelExperiment: 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. |
| Control-waiting list | Other | Other: Vaccine Education Program Based on Integrated Change ModelControl (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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaccine Education Program Based on Integrated Change ModelVaccine 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. | Other | Control-waiting list, Experimental |
Primary outcome
Vaccine literacy
Time frame: 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).
Vaccine advocacy intention
Time frame: 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 attitudes
Time frame: 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).
2 secondary outcomes
Vaccine knowledge level and sources of vaccine information
Time frame: 01.08.2023-31.08.2023 (within 1 month on average)
Sources of vaccine information
Time frame: 01.08.2023-31.08.2023 (within 1 month on average)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Derived from this study: PubMed 39891641Yorulmaz-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.
- 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.Link provided by the sponsor.
- Aharony N, Goldman R, (2017). E-health literacy and the vaccination dilemma: an Israeli perspective. Information Research, 22(2), paper 751.Link provided by the sponsor.
- Aygün E, Tortop HS, 2020. Ebeveynlerin aşı tereddüt düzeylerinin ve karşıtlık nedenlerinin incelenmesi. Güncel Pediatri, 18(3), 300-16.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Hasar M, Özer ZY, Bozdemir N, 2021. Aşı reddi nedenleri ve aşılar hakkındaki görüşler. Cukurova Medical Journal, 46(1), 166-76.Link provided by the sponsor.
- Akın B, \& Koçoğlu, D. (2017). Randomize kontrollü deneyler. Hacettepe Üniversitesi Hemşirelik Fakültesi Dergisi, 4(1), 73-92.Link provided by the sponsor.
- Individual participant dataSharing planned: No. The personal information of the participants will only be used by the researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaccine Education Program Based on Integrated Change Model in people with Unrecognized Condition, run by Artvin Coruh University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccine literacy (time frame: 01.08.2023-31.08.2023 (within 1 month on average)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05929053, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.