Enhancing Influenza Vaccination by Optimising Mood in Older Adults: a Randomised Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 654
- 试验地点
- 2
- 主要终点
- Self-Reported Mood- Affective Slider
研究概览
简要总结
Randomised control trial comparing the effects of a standardised and individualised positive affect digital intervention versus usual care on mood and antibody responses to influenza vaccination in older adults.
详细描述
Infectious diseases are important causes of morbidity and mortality worldwide, and vaccinations are vital to reducing the risk of disease. Vaccine efficacy, however, is dependent on the immune system's ability to respond to vaccination antigens. Influenza vaccines play an important role in combating influenza. However, some populations, such as older adults, respond poorly to vaccination due to their compromised immune systems, with efficacy at 17-53% (compared to 70-90% in young adults).
Behavioural and psychological influences have been shown to alter immune responses. An observational study looking into behavioural and psychological effects, which have been identified as immune modulators (stress, physical activity, nutrition, mood and sleep) found greater positive mood on the day of vaccination predicted significantly greater antibody responses to influenza vaccination. Following this, a feasibility study carried out on 110 older adults demonstrated the ability to enhance positive mood prior to influenza vaccination using a brief digital intervention.
The clinical trial will be the next phase of this research, where the cohort will consist of 650 participants, aged over 65 years, who will receive the quadrivalent, cell-grown influenza vaccination, immediately after one of three conditions. These conditions include: the control arm of usual participant care for vaccination; participants watching a 15-minute digital intervention via a tablet that does not allow content selection; and a personalised digital intervention that allows for participant selection of content they would like to view for 15 minutes. The purpose of these digital interventions is to enhance positive mood of patients prior to vaccination.
The primary aim of this trial is to explore which of two brief interventions has the largest effect on positive mood, compared with usual care. The secondary aim is to measure vaccine specific antibody responses, with the hypothesis that individuals with enhanced positive mood will present larger vaccine specific antibody responses.
This trial will also allow data collection on exploring recruitment, attrition, intervention engagement, and practicality of collecting clinical data available through electronic records and self-report measures to inform the design of a future definitive trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Note: Blinding not possible for usual care group
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and Females aged 65-85 years (inclusive)
- •Received influenza vaccination for the 2018/19 season
- •Eligible to receive 2019/20 influenza vaccination as part of usual care
- •Ability to give informed consent
排除标准
- •Males and Females aged less than 65 or over 85 years (exclusive)
- •Did not receive influenza vaccination for the 2018/19 season
- •Ineligible to receive 2019/20 influenza vaccination as part of usual care
- •Unable to provide informed consent
- •Deemed by health care provider to be:
- •Too physically frail to participate
- •Diagnosed with dementia or other cognitive condition which would make participation difficult
- •Insufficient command of English language
- •Influenza vaccination contraindicated
- •Sufficiently impaired of hearing or vision that exposure to the intervention video content as intended would be compromised
- •Those for whom the collection of blood samples is contraindicated
- •Those who have participated previously in the pilot study (NCT03144518).
结局指标
主要结局
Self-Reported Mood- Affective Slider
时间窗: Baseline, immediately post- intervention (15- 20 minutes post baseline)
Self-reported mood will be measured using three validated patient-reported outcome measures to determine changes in mood from before to after usual care/ intervention arms. One of the three outcome measures includes the Affective Slider (AS), which is a slider scale that is measures a single value on a continuous normalised scale ranging from 0-1, with a central, default thumb position value equal to 0.5, where 0 is low and 1 is high.
Self-Reported Mood- Scale of Positive and Negative Experience
时间窗: Baseline, immediately post- intervention (15- 20 minutes post baseline)
The second outcome measure of changes in mood will be the Scale of Positive and Negative Experience (SPANE), where participants rate 12 emotion words from 1 to 5, where 1 is Not at all and 5 is Very. The overall affect is then determined using these scores and can also be divided out into positive and negative feelings scales.
Self-Reported Mood- Happy-Sad and Alert-Sleepy Dynamic Visual Analogue Mood Scales
时间窗: Baseline, immediately post- intervention (15- 20 minutes post baseline)
The third and final measure of changes in mood will be the Happy-Sad and Alert-Sleepy Dynamic Visual Analogue Mood Scales (DVAMS), which is a morphing image scale that is gender specific and changes when the participant moves the slider scale. The scale ranges from 0 to 100, where 0 is low and 100 is high. The central, default thumb position value is 50.
次要结局
- Recruitment(From the time of recruitment to the start of the Randomised Control Trial)
- Influenza vaccination-specific antibody responses- Haemagglutination inhibition assay(Baseline, 4 weeks post-vaccination)
- Influenza vaccination-specific antibody responses- IgG-specific enzyme-linked immunosorbent assay(Baseline, 4 weeks post-vaccination)
- Number of participants who experience flu-like symptoms and self care(6 months)
- Number of participants who do not follow up with trial procedures- Attrition(Baseline, immediately post- intervention, 4 weeks post-vaccination, 6 months post-vaccination)