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提高芹苴老年人流感疫苗接种率的沟通干预措施 (CIVECT)

2026年9月25日 更新者:Can Tho University of Medicine and Pharmacy

社区传播干预措施提高越南老年人流感疫苗接种率的有效性:一项整群随机对照试验

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.

研究概览

详细说明

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:

All eligible permanent residents aged above 65 years at each study site were invited to participate. Data are collected at two independent cross-sectional time points:

  • T0: Baseline survey, August 2025 (n=952)
  • T1: Follow-up survey, September 2026 (n=approximately 1,200) Participants at T0 and T1 are not necessarily the same individuals; the design captures population-level changes within randomised clusters.

INTERVENTION (12 months: September 2025 to September 2026):

The 12-month duration encompasses both active implementation and the time required for knowledge, attitude, and behaviour change.

Phase 1 (September 2025, intensive activities):

  • Two community health education sessions per intervention site for adults aged >65 years and one cohabiting family member, with distribution of printed educational leaflets on influenza disease and vaccination. Attendance: O Mon Ward: Session 1 = 60 older adults + 40 family members, Session 2 = 57 older adults + 35 family members; Truong Thanh Commune: Session 1 = 60 + 38, Session 2 = 50 + 30.
  • One capacity-building workshop per site for healthcare workers and community health volunteers in vaccination counselling (O Mon Ward: n=30; Truong Thanh Commune: n=20).
  • Thirty household visits per site by trained community health volunteers to reinforce vaccination counselling.

Phase 2 (September 2025 to September 2026, ongoing):

  • Health communication banners displayed at health stations and community information centres throughout the intervention period.
  • Healthcare worker vaccination counselling integrated into all routine clinical contacts at intervention site health stations.
  • Zalo-based digital communication: weekly educational content and personalised vaccination reminders (December 2025 to January 2026, coinciding with peak influenza season in southern Vietnam).

CONTROL GROUP:

Received routine primary healthcare only, with no additional study-related activities.

ANALYSIS:

Effectiveness is measured using Difference-in-Differences (DID) regression, comparing changes between T0 and T1 across intervention and control clusters. Models use multivariable logistic regression (binary outcomes) and linear regression (continuous outcomes), adjusted for sociodemographic covariates. Intraclass correlation coefficients (ICC) were estimated for all outcomes and found to be negligible (ICC < 0.01), confirming the appropriateness of individual-level DID analysis.

研究类型

介入性

注册 (实际的)

1237

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Can Tho City
      • Can Tho、Can Tho City、越南、900000
        • Can Tho University of Medicine and Pharmacy

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

66年 及以上 (年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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).

A 12-month cluster-level communication intervention (Sep 2025-Sep 2026) delivered in two phases to all adults aged >65 years in intervention clusters:

Phase 1 (Sep 2025): (1) Two community health education sessions/site with influenza leaflets for older adults and family members; (2) HCW capacity-building workshop/site (O Mon: n=30; Truong Thanh: n=20); (3) Thirty household visits/site by community health volunteers.

Phase 2 (ongoing): (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 educational content and vaccination reminders (Dec 2025-Jan 2026).

无干预: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Influenza vaccination uptake in the preceding 12 months
大体时间: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.

Up to 12 months

次要结果测量

结果测量
措施说明
大体时间
Influenza vaccination in calendar year 2025
大体时间:Up to 12 months

Proportion vaccinated against influenza during calendar year 2025, assessed by self-report at follow-up (September 2026).

Up to 12 months
Influenza vaccination intention
大体时间:Baseline and up to 12 months

Proportion intending to receive influenza vaccination in the next 12 months, assessed by self-report at baseline (August 2025) and follow-up (September 2026).

Baseline and up to 12 months
Healthcare worker vaccination counselling
大体时间:Baseline and up to 12 months

Proportion who received influenza vaccination counselling from a healthcare worker or community health volunteer in the preceding 12 months, assessed by self-report at baseline (August 2025) and follow-up (September 2026).

Baseline and up to 12 months
Influenza knowledge score
大体时间:Baseline and up to 12 months

Total knowledge score (0-6) on influenza disease aetiology, transmission, complications, and vaccine characteristics. Higher scores indicate greater knowledge. Assessed at baseline (August 2025) and follow-up (September 2026). Analysed using linear regression DID.

Baseline and up to 12 months
Vaccine hesitancy score (WHO-SAGE Vaccine Hesitancy Scale)
大体时间:Baseline and up to 12 months

Vaccine hesitancy measured using the WHO-SAGE Vaccine Hesitancy Scale (Vietnamese-adapted version). Higher scores indicate greater hesitancy. Assessed at baseline (August 2025) and follow-up (September 2026). Analysed using linear regression DID.

Baseline and up to 12 months
Willingness to pay for influenza vaccination
大体时间:Baseline and up to 12 months

Proportion willing to pay out-of-pocket costs for influenza vaccination, assessed by self-report binary question at baseline (August 2025) and follow-up (September 2026).

Baseline and up to 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年9月1日

初级完成 (实际的)

2026年9月9日

研究完成 (实际的)

2026年9月9日

研究注册日期

首次提交

2026年3月27日

首先提交符合 QC 标准的

2026年3月27日

首次发布 (实际的)

2026年4月2日

研究记录更新

最后更新发布 (实际的)

2026年9月28日

上次提交的符合 QC 标准的更新

2026年9月25日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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