NCT07508189

Brief Summary

This study evaluates the effectiveness of a community-based communication intervention to increase influenza vaccination rates among the elderly (aged above 65) in Can Tho City, Vietnam. Using a cluster randomized controlled trial design, the intervention includes direct counseling, social media engagement (Zalo), and educational materials targeting the elderly, their relatives, and local health workers. The primary goal is to assess changes in vaccination coverage over a 9-month period.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress95%
Sep 2015Dec 2026

Study Start

First participant enrolled

September 1, 2015

Completed
10.6 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 2, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

11 years

First QC Date

March 27, 2026

Last Update Submit

April 3, 2026

Conditions

Keywords

Influenza VaccinesElderlyHealth CommunicationVaccination CoverageCommunity-based InterventionVietnam

Outcome Measures

Primary Outcomes (1)

  • Change in Influenza Vaccination Coverage Rate

    The primary outcome is the change in the proportion of elderly participants who received the influenza vaccine from baseline to 12 months. Effectiveness will be evaluated by comparing the intervention and control groups using the Difference-in-Differences (DID) analytical method.

    Baseline (Month 0) and Post-intervention (Month 12)

Study Arms (2)

Multi-component Health Communication

EXPERIMENTAL

Elderly participants in this arm will receive a multi-component health communication package, including direct counseling from health workers, social media engagement via Zalo, and printed materials (leaflets).

Behavioral: Multi-component Health Communication Package

Routine Immunization Information

NO INTERVENTION

Participants in this arm receive standard care and routine immunization information provided by the local health station without the additional communication package.

Interventions

A 12-month intervention program consisting of: 1) Direct health counseling; 2) Weekly educational content shared via Zalo; and 3) Distribution of influenza vaccination leaflets.

Multi-component Health Communication

Eligibility Criteria

Age66 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Residents living in selected wards/communes in Can Tho City for at least 6 months.
  • Aged above 65 years.
  • Mentally and physically capable of participating in interviews and receiving communication interventions.
  • Agree to participate in the study and provide informed consent.

You may not qualify if:

  • Individuals with severe cognitive impairment or dementia.
  • Individuals with contraindications to influenza vaccination.
  • Planning to move out of the study area during the 12-month follow-up period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Can Tho University of Medicine and Pharmacy

Can Tho, Can Tho City, 900000, Vietnam

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to the nature of the community-based health communication intervention, masking of participants and investigators is not feasible.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A cluster randomized controlled trial where wards/communes are the unit of randomization. Participants in intervention clusters receive multi-component communication, while control clusters receive standard care.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2026

First Posted

April 2, 2026

Study Start

September 1, 2015

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared with other researchers to ensure the privacy and confidentiality of the study participants, in accordance with local ethical guidelines and institutional policies. Only aggregated results will be made available through publications.

Locations