跳至主要内容
临床试验/NCT05691790
NCT05691790招募中不适用

Empowering Older People's Preventive Care Utilization Through Mental Model Approach and Patient Activation Approach: a Randomized Control Trial for Promoting Vaccination Uptake

The University of Hong Kong2 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
270
试验地点
2
主要终点
Change of Uptake Rate of the Three Recommended Vaccines from Baseline to within 1 Month and 4 Months after Interventions

研究概览

简要总结

Objectives: To empower older people's decision making for taking the recommended vaccines including seasonal influenza vaccines, pneumococcal vaccines, and COVID-19 vaccine (if it is recommended annually).

Hypotheses to be tested: The interventions designed using Mental Models Approach and Patient Activation Approach will promote older people's confidence in knowledge and skills regarding vaccination decisions, perceived self-efficacy in self-management of health, positive emotional engagement with vaccination decisions and a positive future time perspective which will subsequently promote their uptake of the recommended vaccines.

Design and subjects: This will be a two-arm randomized control trial. Subjects will be community-dwelling older people aged 70 years or above.

Instruments: A questionnaire will be used to collect baseline data before the interventions and follow-up data 1 months and 4 months, respectively, after the end of interventions.

Interventions: Interventions included one booklet to communicate information about preventive care by bridging expert knowledge and older people's existing mental models, and six patient activation sections conducted over telephone. One patient activation section will be delivered per week by trained medical students.

Main outcome measures: Main outcomes will be participants' uptake of the three recommended vaccines assessed at 1 month and 4 months after the end of interventions.

Data analysis and expected results: Generalized estimating equation logistic regression will be used to assess the intervention effects. The investigators expect that the interventions can promote at least 20% increase in uptake of any one of the three recommended vaccines in the intervention group compared with the control group.

详细描述

  1. Introduction:

The global population aged above 60 years is projected to reach 2.1 billion by 2050. Hong Kong also has a rapid aging population. In 2018, there were around 1.27 million people aged 65 years or above, accounting for 17.9% of the total population in Hong Kong, which was estimated to increase to 2.44 million and 31.9% of the total population by 2038. Age increases with a sharp rise in multimorbidity. In Hong Kong, it was estimated that around 70% of the population aged 60 years or above had at least one chronic disease and 40% had multimorbidity. This will cause substantial burden to the health care systems.

Underutilization of preventive care in older people Encouraging older people's utilization of preventive care is crucial for reducing the pressure of population aging placed on the health care systems and promoting healthy aging. In England, it was estimated that regular health check-up can prevent 390 premature deaths and gain an additional 1,370 people being free of disease per million people before age of 80 years. A meta-analysis estimated that influenza vaccination in older people reduced hospital admission due to influenza or pneumonia by 27% and all-cause mortality by 47%. Adding pneumococcal vaccination to influenza vaccination can additionally prevent pneumonia and death by 15% and 19%, respectively. However, underutilization of preventive care was widespread. For instance, it was reported that only 40% of the Hong Kong older people had regular medical check-ups to screen for chronic diseases. In Hong Kong, free or subsidized influenza vaccination and pneumococcal vaccinations are provided for older people aged 50 years or above and those aged 65 years or above, respectively. However, only 45% of the target age group received seasonal influenza vaccines in 2020/2021 and 46% had received pneumococcal vaccines as of February 2021. In addition, older people were found to be much more hesitant about taking COVID-19 vaccination, with less than 20% of persons aged 60 or older being vaccinated 6 months after the COVID-19 vaccination programme launched in Hong Kong.

Linking to older people's decision-making preference Preventive care utilization involves a decision-making process of identifying available preventive care options, evaluating these options based on available information or by engagement with information seeking and finally choosing the favourable options. This is a cognitively demanding process. However, age increases with decline in cognitive function. Attributing to their declined cognitive function, older people tend to seek less information, favour fewer options and simpler information in decision making, and have poorer decision-making competence. However, older people were suggested to have better emotional and experiential skills which sometimes compensate their declined cognitive function in decision making. Older people's decision making tend to be gain-oriented and they were better at making use of positive information than negative information in decision making. Older people had greater cognitive engagement in decisions that were more emotionally relevant, and better performance in recognizing social norms-related cues in decision making. Older people's better performance in affective decision making may be explained using the Socioemotional Selectivity Theory (SST). According to SST, older people naturally perceive that they have limited time for future and hence they selectively pay more attention to the emotional contents of the decisions, put more effort to decisions that are more emotionally meaningful for them, and value more for optimizing emotional experience and maintaining emotional connectivity with others in decision making. Most existing studies to examine older people's decision making preference focused on the financial domain and few studies linked older people's decision-making preference to preventive care utilization.

Thus, older people should need support to facilitate preventive care utilization. First, due to decline in cognitive function, older people may need support for identifying available preventive care services suitable for their age groups and recognizing personal need for preventive care. The investigators' previous study found that older people generally had insufficient understanding about what preventive care was. For instance, healthy lifestyle was the most frequently mentioned preventive care while other preventive care services were not recognized. Some had misperceptions about preventive care. The investigators' recent qualitative study found that older people misinterpreted pneumococcal vaccination as a curative care rather than preventive care (unpublished data). Inability to distinguish preventive care from curative care shaped a misperception that need for preventive care depended on somatic symptoms. Second, information should be presented in a way of being emotionally relevant for older people, emphasizing the benefits of behaviours rather than prevention of loss, to eventually facilitate the achievement of emotional positivity, stability, and connectivity. However, current advocacy for preventive care in older people remains primarily based on the conventional three-level disease prevention model emphasizing prevention of loss. This may reduce older people's motivation to cognitively engage in understanding and making use of the information for preventive care utilization. Third, preventive care utilization requires older people to be more future-oriented, actively planning and striving for a better future. However, it was found that older people particularly those who were 70 years or above had a more negative view of and feeling helpless about the present-the present fatalistic perspective which impaired their decision making competence. This suggests the importance of promoting a positive future time perspective particularly in those who are 70 years or older for promoting their preventive health behaviours. Review of literature suggested that older people in general had lower self-efficacy in decision making. Meanwhile healthcare professional and family tend to leave the medical decisions to older people themselves to avoid feeling of regret once wrong decision is made, which is a case in Hong Kong regarding older people's COVID-19 vaccination.

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
Double (Participant, Investigator)

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Community-dwelling older persons aged 70 years who did not persistently receive seasonal influenza vaccine over the past three years (2020-2022) and/or have never received the pneumococcal vaccine (one dose of the 23-valent pneumococcal polysaccharide vaccine (23vPPV) or the 13-valent pneumococcal conjugate vaccine (PCV13)).
  • Being able to communicate with Cantonese, or Mandarin (the two main spoken language in Hong Kong) and being able to read Chinese.
  • Inclusion criteria for the informant include age above 18 and can understand Cantonese or Mandarin

排除标准

  • having psychiatric disorders, dementia, or other cognitive difficulties which impede communication or understanding of the intervention and having functional disabilities which impede access to health care services.
  • subjects who had medical contraindications for immunization.

结局指标

主要结局

Change of Uptake Rate of the Three Recommended Vaccines from Baseline to within 1 Month and 4 Months after Interventions

时间窗: Assessed at baseline, within 1 month and 4 months after the end of interventions.

Participants' uptake rate of the three recommended vaccines (influenza vaccines, pneumococcal vaccines, and COVID-19 vaccines).

次要结局

  • Changes in Patient Activation Measure from baseline to within 1 month after intervention ends(At baseline and within one month after the end of the intervention (in the 1st follow-up assessment))
  • Changes in other preventive care utilization from baseline to within 1 month and 4 months after intervention ends(At baseline and within one month (in the 1st follow-up assessment) four months (2nd outcome assessment) after the end of the intervention)
  • Changes in Emotional engagement with vaccination decisions measurement from baseline to within 1 month after intervention ends(At baseline and within one month after the end of the intervention (in the 1st follow-up assessment))
  • Changes in Future time perspective measurement from baseline to within 1 month after intervention ends(At baseline and within one month after the end of the intervention (in the 1st follow-up assessment))
  • Changes in lifestyle behaviours from baseline to within 1 month and 4 months after intervention ends(At baseline and within one month (in the 1st follow-up assessment) and four months (2nd outcome assessment)after the end of the intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Qiuyan Liao

Principal Investigator

The University of Hong Kong

研究点 (2)

Loading locations...

相似试验