Flu and Mood in Older Adults

NCT03956329 | Completed

• 1 other identifier: 19004
• Study Type: interventional
• Target: 654
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaccination; Infection

Keywords

Positive Affect; Influenza Vaccination; Positive Mood; Vaccination; Randomised Control Trial

Outcome Measures

Primary Outcomes (3)

• Self-Reported Mood- Affective Slider

  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.

  Baseline, immediately post- intervention (15- 20 minutes post baseline)

• Self-Reported Mood- Scale of Positive and Negative Experience

  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.

  Baseline, immediately post- intervention (15- 20 minutes post baseline)

• Self-Reported Mood- Happy-Sad and Alert-Sleepy Dynamic Visual Analogue Mood Scales

  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.

  Baseline, immediately post- intervention (15- 20 minutes post baseline)

Secondary Outcomes (5)

• 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

• Recruitment

  From the time of recruitment to the start of the Randomised Control Trial

Study Arms (3)

Usual care, control arm

NO INTERVENTION

Usual care in which participants will not see a video intervention. This group will attend their influenza vaccination appointment as usual, without intervention. Participants will receive Northern Hemisphere Influenza Vaccine 2019/20 (Delivered as part of Standard Care).

Standardised Digital Intervention

EXPERIMENTAL

Video intervention designed to induce an increase in positive mood in older adults. Includes comedy clips, uplifting music and positive imagery. Intervention approximately 15-20 minutes in length. Following intervention, participants will receive the Northern Hemisphere Influenza Vaccine 2019/20 (Delivered as part of Standard Care).

Other: Standardised Digital Intervention

Individualised Digital Intervention

EXPERIMENTAL

Similar to the standardised digital intervention, however participants will be able to individualise the intervention by choosing video clips from a limited menu of choices. Intervention approximately 15-20 minutes in length. Following intervention, participants will receive the Northern Hemisphere Influenza Vaccine 2019/20 (Delivered as part of Standard Care).

Other: Individualised Digital Intervention

Interventions

Standardised Digital Intervention OTHER

Video intervention designed to induce an increase in positive mood in older adults. Includes comedy clips, uplifting music and positive imagery. Intervention approximately 15-20 minutes in length. 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.

Standardised Digital Intervention

Individualised Digital Intervention OTHER

Similar to the standardised digital intervention, however, participants will be able to individualise the intervention by choosing video clips from a limited menu of choices. Intervention approximately 15-20 minutes in length. The 4 categories include stand-up comedy (Michael McIntyre, Tim Vine and Victoria Wood), sit-com (Fawlty Towers, Only Fools and Horses and Two Ronnies), music (Elvis Presley, Last Night at the Proms, Roy Orbison) and variety (Britain's Got Talent, Strictly Come Dancing, Terry Wogan). Participants are able to select 3 of the videos, which are roughly 5 minutes in length, to reach a total of 15-20 minutes of content.

Individualised Digital Intervention

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Nottingham: lead
• Public Health England: collaborator

Study Sites (1)

University of Nottingham

Nottingham, Nottinghamshire, NG7 2RD, United Kingdom

Location

Related Publications (7)

• 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.

  PMID: 28923405 BACKGROUND

• 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.

  PMID: 18297169 BACKGROUND

• 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.

  PMID: 16213065 BACKGROUND

• 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.

  PMID: 15564363 BACKGROUND

• 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.

  PMID: 26849361 BACKGROUND

• 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.

  PMID: 28653547 BACKGROUND

• Ayling K, Brown M, Carlisle S, Bennett R, Buchanan H, Dumbleton J, Hawkey C, Hoschler K, Jack RH, Nguyen-Van-Tam J, Royal S, Turner D, Zambon M, Fairclough L, Vedhara K. Optimizing mood prior to influenza vaccination in older adults: A three-arm randomized controlled trial. Health Psychol. 2024 Feb;43(2):77-88. doi: 10.1037/hea0001267. Epub 2023 Dec 7.

  PMID: 38059932 DERIVED

MeSH Terms

Conditions

Infections; Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Kavita Vedhara

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Note: Blinding not possible for usual care group
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 20, 2019
• Study Start: August 12, 2019
• Primary Completion: November 7, 2019
• Study Completion: May 30, 2020
• Last Updated: October 6, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)