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

The Effect of Telehealth Service Provided to Pregnant Women About Childhood Vaccines on Vaccine Attitudes and Vaccination

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.

Study Overview

• Status: Completed
• Conditions: Vaccination; Vaccine Refusal
• Intervention / Treatment: Behavioral: Telehealth service

Detailed Description

Place and Time of Research; The research will be carried out at primary care clinics in Istanbul Beylikdüzü between August 2022 and March 2023.

Population and Sample of the Research; The research population will consist of individuals who were last trimester of pregnancy in primary care clinics in Istanbul Beylikdüzü. The study sample will consist of at least 156 individuals determined by power analysis. Individuals who met the inclusion criteria were randomly assigned to the experimental and control groups with a table of random numbers.

In this study, the scales will be applied as a pre-post test. It does not pose any problem that will endanger the physical and mental health of the participants. Data collection forms; introductory information form, vaccine attitudes scale, vaccine follow-up form, and follow-up chart. Data collection tools; vaccination information video, e-brochures, reminder messages, answering parent questions via instant message, smartphone.

Before starting the research, ethics committee approval was obtained from Istanbul University-Cerrahpaşa Social and Human Sciences Ethics Committee, and institutional permission was obtained from the Istanbul Provincial Health Directorate. Participants were included in the study voluntarily. Before starting the study, participants were called by phone and informed about the study, and verbal consent was obtained with the "Informed Voluntary Consent Form."

• Study Type: Interventional
• Enrollment (Actual): 183
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Beylikdüzü
    • Istanbul, Beylikdüzü, Turkey, 34520
      • Primary Care Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Have a miscarriage

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telehealth group; The group in which telehealth services for childhood vaccines will be implemented.	Behavioral: Telehealth service; 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.
No Intervention: Control group; The group in which telehealth services for childhood vaccines will not be implemented.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Gozde AKSUCU
• Collaborators: Istanbul University - Cerrahpasa (IUC)
• Investigators: Study Chair: Gözde AKSUCU, MSc, Beykent University; Principal Investigator: Seda Caglar, PhD, Istanbul University - Cerrahpasa (IUC)

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: January 25, 2023
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (Actual): February 6, 2023

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Telehealth; Vaccination; Vaccine hesitation; Vaccine attitudes; Childhood immunization
• Other Study ID Numbers: 2021/295

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No