The Effect of Telehealth Service About Childhood Vaccines on Vaccine Attitudes and Vaccination

NCT05713526 | Completed

• 1 other identifier: 2021/295
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to test the effect of telehealth service provided to pregnant women about childhood vaccines on vaccine attitudes and vaccination. The main questions it aims to answer are:

• Does telehealth service provided to pregnant women about childhood vaccines decrease the mean scores of the vaccine attitudes scale?
• Does telehealth service provided to pregnant women about childhood vaccines increase the vaccination? In the intervention group, researchers will send educational materials (video and e-brochures) about childhood vaccinations to the participants' mobile phones at regular intervals, answer their questions over the phone and send reminder messages before the vaccination appointment. In the control group, there will be no information or intervention about childhood vaccines by the researchers, and standard procedure will be followed. Researchers will compare the intervention and control groups to see if there is a difference between vaccination attitudes and vaccination rates.

Conditions

Vaccine Refusal; Vaccination

Keywords

Telehealth; Vaccine hesitation; Vaccine attitudes; Vaccination; Childhood immunization

Outcome Measures

Primary Outcomes (7)

• Vaccine attitudes (Vaccine Attitudes Scale)

  The scale was developed by Wallece et al. in 2019. The Turkish validity and reliability study was carried out by Ceylan et al. in 2021. The scale consists of 11 items in a 3-point Likert type that measures parents' attitudes toward vaccines. The scale has five sub-dimensions consisting of "benefits of the vaccine", "past vaccination behavior", "efficacy and safety", "awareness of vaccine-preventable diseases" and "confidence". Each item is scored between 1 and 3 (agree=1, undecided=2, disagree=3). The total score on the scale ranges from 11 to 33. 11 points indicate that parents have a positive attitude toward the vaccine, while 33 points indicate a negative attitude. The scale does not have a breakpoint. As the score obtained from the scale increases, the parents' hesitance toward vaccination increases, and that is, they show a negative attitude towards vaccination. Cronbach's alpha coefficient was calculated by Ceylan (2021) as 0.66 to evaluate the scale's internal consistency.

  Before the intervention

• Vaccine attitudes (Vaccine Attitudes Scale)

  The scale was developed by Wallece et al. in 2019. The Turkish validity and reliability study was carried out by Ceylan et al. in 2021. The scale consists of 11 items in a 3-point Likert type that measures parents' attitudes toward vaccines. The scale has five sub-dimensions consisting of "benefits of the vaccine", "past vaccination behavior", "efficacy and safety", "awareness of vaccine-preventable diseases" and "confidence". Each item is scored between 1 and 3 (agree=1, undecided=2, disagree=3). The total score on the scale ranges from 11 to 33. 11 points indicate that parents have a positive attitude toward the vaccine, while 33 points indicate a negative attitude. The scale does not have a breakpoint. As the score obtained from the scale increases, the parents' hesitance toward vaccination increases, and that is, they show a negative attitude towards vaccination. Cronbach's alpha coefficient was calculated by Ceylan (2021) as 0.66 to evaluate the scale's internal consistency.

  After the 6th month's vaccinations

• Vaccination

  Vaccination status on the day of the appointment

  When the birth occurs

• Vaccination

  Vaccination status on the day of the appointment

  When the baby is at the end of the 1st month

• Vaccination

  Vaccination status on the day of the appointment

  When the baby is at the end of the 2nd month

• Vaccination

  Vaccination status on the day of the appointment

  When the baby is at the end of the 4th month

• Vaccination

  Vaccination status on the day of the appointment

  When the baby is at the end of the 6th month

Study Arms (2)

Telehealth group

EXPERIMENTAL

The group in which telehealth services for childhood vaccines will be implemented.

Behavioral: Telehealth service

Control group

NO INTERVENTION

The group in which telehealth services for childhood vaccines will not be implemented.

Interventions

Telehealth service BEHAVIORAL

Researchers will send educational materials (video and e-brochures) about childhood vaccinations to the participants' mobile phones at regular intervals, answer their questions over the phone and send reminder messages before the vaccination appointment.

Telehealth group

Eligibility Criteria

• Gender Eligibility Details: Since pregnancy is specific to women, the study will be conducted for women.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteering to participate in the study
• Having the ability to understand, speak, read and write Turkish.
• The willingness of the primary care clinic staff to be cooperated to work
• Owning and using a smartphone
• Being in the last trimester of pregnancy
• Giving birth to the baby at a birth weight (≥ 2000 g) that will not affect the routine vaccination schedule

You may not qualify if:

• Have a miscarriage

Sponsors & Collaborators

• Gozde AKSUCU: lead
• Istanbul University - Cerrahpasa: collaborator

Study Sites (1)

Primary Care Clinics

Istanbul, Beylikdüzü, 34520, Turkey (Türkiye)

Location

Related Publications (1)

• Aksucu G, Caglar S. Effects of telehealth during pregnancy on childhood vaccine attitudes and timeliness: A randomized controlled trial. Vaccine. 2025 Sep 17;63:127678. doi: 10.1016/j.vaccine.2025.127678. Epub 2025 Aug 28.

  PMID: 40882266 DERIVED

MeSH Terms

Conditions

Vaccination Refusal

Condition Hierarchy (Ancestors)

Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Gözde AKSUCU, MSc

  Beykent University

  STUDY CHAIR

• Seda ÇAĞLAR, PhD

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant

Model Details: Pretest-posttest with the control group.

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 6, 2023
• Study Start: August 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: May 1, 2023
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)