Effectiveness of Community-Based Communication Interventions to Improve Influenza Vaccination Rates Among the Elderly in Vietnam: A Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,237
- 试验地点
- 1
- 主要终点
- Influenza vaccination uptake in the preceding 12 months
研究概览
简要总结
This study evaluates the effectiveness of a multi-component community-based communication intervention to increase influenza vaccination rates among adults aged above 65 years in Can Tho City, Vietnam. Using a cluster randomised controlled trial design with stratified lottery randomisation, four study sites were selected from eight sites surveyed in a prior study: O Mon Ward and Truong Thanh Commune (intervention); Phuoc Thoi Ward and Truong Xuan Commune (control). The intervention includes community health education sessions, healthcare worker training, household visits, health communication banners, and Zalo-based vaccination reminders, delivered over 12 months (September 2025 to September 2026). Effectiveness is assessed by comparing pre- and post-intervention outcomes using Difference-in-Differences (DID) analysis.
详细描述
This study employs a cluster randomised controlled trial (cluster RCT) design with a repeated cross-sectional approach. The unit of randomisation is the cluster (ward or commune).
RANDOMISATION:
From eight study sites surveyed in Objective 1 (four urban wards and four rural communes in Can Tho City), four sites were selected by stratified lottery randomisation. Within each stratum (urban and rural), one site was randomly assigned to the intervention group and one to the control group by lottery draw without investigator discretion:
- Intervention: O Mon Ward (urban) and Truong Thanh Commune (rural)
- Control: Phuoc Thoi Ward (urban) and Truong Xuan Commune (rural)
PARTICIPANTS:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Due to the nature of the community-based health communication intervention, masking of participants and investigators is not feasible.
入排标准
- 年龄范围
- 66 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Multi-component Health Communication
Adults aged >65 years in 2 intervention clusters (O Mon Ward and Truong Thanh Commune) receive a multi-component package:
Phase 1 (Sep 2025): (1) Two community health education sessions/ site for older adults and one family member, with influenza leaflets. (2) One HCW capacity-building workshop/site (O Mon: n=30; Truong Thanh: n=20). (3) Thirty household visits/site by community health volunteers.
Phase 2 (Sep 2025-Sep 2026): (4) Health communication banners at health stations and community centres. (5) HCW point-of-care vaccination counselling at all clinical contacts. (6) Zalo-based weekly reminders and educational content (Dec 2025-Jan 2026).
干预措施: Multi-component Health Communication Package (Behavioral)
Routine Immunization Information
Participants in this arm receive standard care and routine immunization information provided by the local health station without the additional communication package.
结局指标
主要结局
Influenza vaccination uptake in the preceding 12 months
时间窗: Up to 12 months
Proportion of participants who received influenza vaccination in the 12 months prior to survey, assessed by self-report. Baseline assessed August 2025; follow-up assessed September 2026. Intervention effect estimated using Difference-in- Differences (DID) regression comparing change between intervention and control clusters.
次要结局
- Influenza vaccination in calendar year 2025(Up to 12 months)
- Influenza vaccination intention(Baseline and up to 12 months)
- Healthcare worker vaccination counselling(Baseline and up to 12 months)
- Influenza knowledge score(Baseline and up to 12 months)
- Vaccine hesitancy score (WHO-SAGE Vaccine Hesitancy Scale)(Baseline and up to 12 months)
- Willingness to pay for influenza vaccination(Baseline and up to 12 months)