NCT05390697

Brief Summary

Vaccine hesitancy and the COVID-19 pandemic may threaten immunization coverage in children. This study aimed to evaluate the tailored educational videos to reduce vaccine hesitancy and analyze immunization completeness status. The investigators conducted an interventional quasi-experimental study in three subdistricts of North Jakarta, Indonesia. Participants were allocated into the intervention and control groups, and the Parent Attitudes about Childhood Vaccines (PACV) questionnaire was used to assess vaccine hesitancy status before and after the intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
Last Updated

May 25, 2022

Status Verified

May 1, 2022

Enrollment Period

6 months

First QC Date

May 16, 2022

Last Update Submit

May 19, 2022

Conditions

Keywords

health educationhealth promotionIndonesiavaccinationvaccination hesitancy

Outcome Measures

Primary Outcomes (1)

  • The Parent Attitudes about Childhood Vaccines (PACV) Questionnaire

    Improvement in vaccine hesitancy among Indonesian parents who underwent educational videos intervention, compared to the maternal and child health (MCH) handbook digital version as a standard educational tool

    Five weeks after intervention

Secondary Outcomes (1)

  • Childhood routine immunization status

    Five weeks after intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

The educational videos included five modules distributed over five weeks.

Other: Educational videos

Control group

NO INTERVENTION

Participants in the control group were given exposure to the digital version of the MCH handbook, 2020 edition, consisting of animated pictures and simple instructions.

Interventions

Educational videos include (1) danger and prevention of VPD; (2) rationales of completing immunization; (3) immunization amid the COVID-19 pandemic; (4) vaccine misconception; and (5) adverse events following immunization and how to treat it. Each video was less than 2 minutes with clear and straightforward messages according to the National Institute of Health guideline for health education. Materials were distributed through WhatsApp and viewed for five weeks.

Intervention group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parents with children aged 10-18 months
  • Parents who had electronic devices that could play videos, such as smartphones or tablets
  • Registered in the community health centers database.

You may not qualify if:

  • Children had contraindicated for immunization
  • Children were dropped out if they did not finish their studies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Cipto Mangunkusumo Hospital

Jakarta Pusat, 10430, Indonesia

Location

MeSH Terms

Conditions

Vaccination RefusalVaccination HesitancyHealth Education

Condition Hierarchy (Ancestors)

Treatment RefusalTreatment Adherence and ComplianceHealth BehaviorBehaviorAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health Care

Study Officials

  • Hartono Gunardi, MD, PhD

    Fakultas Kedokteran Universitas Indonesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 16, 2022

First Posted

May 25, 2022

Study Start

June 18, 2021

Primary Completion

December 10, 2021

Study Completion

December 10, 2021

Last Updated

May 25, 2022

Record last verified: 2022-05

Locations