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临床试验/NCT03144518
NCT03144518已完成不适用

A Feasibility Trial of a Brief Positive Affect Intervention to Improve the Effectiveness of Influenza Vaccine Response in Older Adults.

University of Nottingham1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2017年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
106
试验地点
1
主要终点
Mood Outcome Scores [Multiple]

研究概览

简要总结

This study is a 2-arm, parallel, randomised controlled feasibility trial of a brief video intervention designed to induce positive affect (mood) in older adults in primary care settings prior to the receipt of influenza vaccination. Participants will be randomised into two conditions: experimental and active control. In the experimental condition, participants will view the approximately 15 minute long intervention video immediately prior to vaccination. In the active control condition, participants will view a matched video that is designed to be mood neutral. Pre-and-post positive affect levels will be assessed by self-report questionnaires. Immune response to the intervention and vaccination responses will be assessed in saliva and serum samples respectively.

The objectives of the study are to assess the impact of the intervention on mood, immune function, and antibody response to influenza vaccination in older adults. This feasibility trial will also allow data collection on exploring recruitment, attrition, intervention engagement, and practicality of collecting clinical data available through electronic records to inform the design of a future definitive trial.

详细描述

The Centers for Disease Control (CDC) describe vaccinations as among the 10 most significant health achievements ever documented; and for many conditions they have been an unmitigated success (e.g., smallpox). There are, however, several populations in whom vaccine effectiveness is far from optimal. These populations are typically contending with underlying immune impairment by virtue of their advancing age and/or the presence of co-existing diseases (e.g., cancer). As a consequence, vaccines are most likely to fail those whom they most seek to benefit: individuals at the greatest risk of ill health.

This has prompted research into treatments that enhance immune function prior to vaccination, so called vaccine adjuvants. The aim of such treatments is to optimise the response the immune system makes to the vaccine antigens and, in so doing, increase the likelihood that the vaccine confers protection.

One area in which there has been interest is in the potential for developing psycho-behavioural vaccine adjuvants. There is considerable evidence that psychological and behavioural factors can modulate immunity; with diet, physical activity, stress, affect, sleep and social support all associated with immune response.

The investigators recently conducted a longitudinal observational cohort study of multiple psychological (positive affect, negative affect, stress) and behavioural (physical activity, sleep, diet) influences on short and long-term antibody responses to influenza vaccination in older adults. This identified positive affect as the most influential psycho-behavioural factor on influenza-specific antibody responses, independently predicting both short and long-term antibody responses in the weakest immunogenic strain above and beyond known demographic and clinical determinants. Intriguingly, the investigators also observed preliminary evidence that positive affect on the day of vaccination was more predictive of antibody responses following vaccination than mood measured over the longer period surrounding vaccination. As influenza-specific antibodies are a well-established correlate of protection from serologically and clinically diagnosed influenza incidence, these data suggest that increasing positive affect immediately prior to vaccination could be used as a non-pharmacological vaccine adjuvant.

Through a series of systematic steps, including focus groups and interviews with older adults and health care professionals, the investigators have recently developed a brief, positive affect intervention - designed to improve short-term mood in older adults and be deliverable within primary care. It is hoped this could act as a psycho-behavioural adjuvant to enhance poor responses to influenza vaccination in older adults. Before performing a definitive trial of the intervention's effectiveness, a feasibility trial is needed for number of reasons:

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)

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

入选标准

  • Males and Females aged 65-85 years (inclusive)
  • Received influenza vaccination for the 2016/17 season
  • Eligible to receive 2017/18 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 2016/17 season
  • Ineligible to receive 2017/18 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 or control video content as intended would be compromised
  • Those for whom the collection of blood samples is contraindicated.

研究组 & 干预措施

Experimental

Experimental

Participants in the experimental condition will view a video designed to induce positive affect. This includes 3 short comedy clips (fork handles sketch, the two Ronnie's; A room with a view - faulty towers; Tim Vine Live stand-up extract), uplifting music (Jailhouse Rock - Elvis Presley; Happy Together - The Turtles), jokes and positive imagery. The content of the intervention has been informed by patient and public involvement, focus groups with older adults, and pilot testing.

干预措施: Positive Affect Intervention (Other)

Experimental

Experimental

Participants in the experimental condition will view a video designed to induce positive affect. This includes 3 short comedy clips (fork handles sketch, the two Ronnie's; A room with a view - faulty towers; Tim Vine Live stand-up extract), uplifting music (Jailhouse Rock - Elvis Presley; Happy Together - The Turtles), jokes and positive imagery. The content of the intervention has been informed by patient and public involvement, focus groups with older adults, and pilot testing.

干预措施: Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care) (Biological)

Active Control

Active Comparator

Participants in the control condition will view a video of matched length to the experimental condition video, but not designed to induce mood change. This includes short documentary clips (a pride in pencils; model railways, lecture extract on hydration), neutral music and images.

干预措施: Neutral Control Intervention (Other)

Active Control

Active Comparator

Participants in the control condition will view a video of matched length to the experimental condition video, but not designed to induce mood change. This includes short documentary clips (a pride in pencils; model railways, lecture extract on hydration), neutral music and images.

干预措施: Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care) (Biological)

结局指标

主要结局

Mood Outcome Scores [Multiple]

时间窗: Baseline, Immediately Post Intervention (i.e, 15 minutes post-baseline).

Affective Slider (Betella \& Verschure, 2016), consists of two single item visual analogue scales. Scores for each are presented as a value from 0 to 100 with higher scores indicating greater pleasure (VAS-Valence) and arousal (VAS-Arousal). Positive and Negative Affect Schedule (Watson et al., 1988). Positive and negative affect subscales were created by summing the scores of positive and negative adjectives respectively. For each sub scale, minimum score = 10, maximum score = 50 with higher scores indicating greater positive and negative affect respectively. Pictorial scale of positive affect (unvalidated, internally developed). Participants completed a single-item photo-based measure of positive affect tailored for older adults. Participants were presented with six groups of images depicting varying degrees of positive affect, and indicate which best reflected how they felt at that moment. Minumum score 1, maximum score 6, higher scores indicate greater positive affect.

次要结局

  • Recruitment(Baseline)
  • Secretory IgA Response(Baseline, Immediately Post Intervention (i.e, 15 minutes post-baseline).)
  • Vaccine Specific IgG Response(4 weeks (post-vaccination), 16 Weeks (post-vaccination))
  • Attrition(4 weeks (post-vaccination), 16 Weeks (post-vaccination))
  • Health Care Utilization(Baseline to 6 months post-vaccination)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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