Clinical trial NCT03956329: Flu and Mood in Older Adults
Official title: Enhancing Influenza Vaccination by Optimising Mood in Older Adults: a Randomised Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccination
Infection
Keywords: Positive Affect
Influenza Vaccination
Positive Mood
Vaccination
Randomised Control Trial
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Public Health England
First posted: 2019-05-20
Enrollment: 654
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Self-Reported Mood- Affective Slider
timeFrame: Baseline, immediately post- intervention (15- 20 minutes post baseline)
measure: Self-Reported Mood- Scale of Positive and Negative Experience
timeFrame: Baseline, immediately post- intervention (15- 20 minutes post baseline)
measure: Self-Reported Mood- Happy-Sad and Alert-Sleepy Dynamic Visual Analogue Mood Scales
timeFrame: Baseline, immediately post- intervention (15- 20 minutes post baseline)
Secondary outcomes:
measure: Influenza vaccination-specific antibody responses- Haemagglutination inhibition assay
timeFrame: Baseline, 4 weeks post-vaccination
measure: Influenza vaccination-specific antibody responses- IgG-specific enzyme-linked immunosorbent assay
timeFrame: Baseline, 4 weeks post-vaccination
measure: Number of participants who experience flu-like symptoms and self care
timeFrame: 6 months
measure: Number of participants who do not follow up with trial procedures- Attrition
timeFrame: Baseline, immediately post- intervention, 4 weeks post-vaccination, 6 months post-vaccination
measure: Recruitment
timeFrame: From the time of recruitment to the start of the Randomised Control Trial
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: University of Nottingham
state: Nottinghamshire
Study officials:
affiliation: University of Nottingham
name: Kavita Vedhara
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ayling K, Fairclough L, Tighe P, Todd I, Halliday V, Garibaldi J, Royal S, Hamed A, Buchanan H, Vedhara K. Positive mood on the day of influenza vaccination predicts vaccine effectiveness: A prospective observational cohort study. Brain Behav Immun. 2018 Jan;67:314-323. doi: 10.1016/j.bbi.2017.09.008. Epub 2017 Sep 18.
citation: Andre FE, Booy R, Bock HL, Clemens J, Datta SK, John TJ, Lee BW, Lolekha S, Peltola H, Ruff TA, Santosham M, Schmitt HJ. Vaccination greatly reduces disease, disability, death and inequity worldwide. Bull World Health Organ. 2008 Feb;86(2):140-6. doi: 10.2471/blt.07.040089.
citation: Goodwin K, Viboud C, Simonsen L. Antibody response to influenza vaccination in the elderly: a quantitative review. Vaccine. 2006 Feb 20;24(8):1159-69. doi: 10.1016/j.vaccine.2005.08.105. Epub 2005 Sep 19.
citation: Moynihan JA, Larson MR, Treanor J, Duberstein PR, Power A, Shore B, Ader R. Psychosocial factors and the response to influenza vaccination in older adults. Psychosom Med. 2004 Nov-Dec;66(6):950-3. doi: 10.1097/01.psy.0000140001.49208.2d.
citation: Betella A, Verschure PF. The Affective Slider: A Digital Self-Assessment Scale for the Measurement of Human Emotions. PLoS One. 2016 Feb 5;11(2):e0148037. doi: 10.1371/journal.pone.0148037. eCollection 2016.
citation: Barrows PD, Thomas SA. Assessment of mood in aphasia following stroke: validation of the Dynamic Visual Analogue Mood Scales (D-VAMS). Clin Rehabil. 2018 Jan;32(1):94-102. doi: 10.1177/0269215517714590. Epub 2017 Jun 27.