Vaccination; Infection Clinical Trial
Official title:
A Feasibility Trial of a Brief Positive Affect Intervention to Improve the Effectiveness of Influenza Vaccine Response in Older Adults.
NCT number | NCT03144518 |
Other study ID # | 17039 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 1, 2017 |
Est. completion date | May 31, 2018 |
Verified date | April 2019 |
Source | University of Nottingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 106 |
Est. completion date | May 31, 2018 |
Est. primary completion date | November 1, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years to 85 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Nottingham | Nottingham |
Lead Sponsor | Collaborator |
---|---|
University of Nottingham | Northumbria University |
United Kingdom,
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. Review. — View Citation
Bryant PA, Trinder J, Curtis N. Sick and tired: Does sleep have a vital role in the immune system? Nat Rev Immunol. 2004 Jun;4(6):457-67. Review. — View Citation
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Jefferson T, Smith S, Demicheli V, Harnden A, Rivetti A, Di Pietrantonj C. Assessment of the efficacy and effectiveness of influenza vaccines in healthy children: systematic review. Lancet. 2005 Feb 26-Mar 4;365(9461):773-80. Review. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mood Outcome Scores [Multiple] | 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. |
Baseline, Immediately Post Intervention (i.e, 15 minutes post-baseline). | |
Secondary | Recruitment | Recruitment rates to inform a future definitive trial | Baseline | |
Secondary | Attrition | Attrition - to inform a future definitive trial | 4 weeks (post-vaccination), 16 Weeks (post-vaccination) | |
Secondary | Secretory IgA Response | Secretory IgA levels measured in saliva samples via ELISA. This is a non-specific measure of immunological response | Baseline, Immediately Post Intervention (i.e, 15 minutes post-baseline). | |
Secondary | Vaccine Specific IgG Response | IgG levels against the 4 vaccine strains measured via ELISA. Values represent equivalent ug/ml based on diluted sample absorbance value interpolation against a standard IgG curve, multiplied by the serum dilution score (i.e., 4000). |
4 weeks (post-vaccination), 16 Weeks (post-vaccination) | |
Secondary | Health Care Utilization | Via medical records, we assessed health care usage potentially attributable to flu-like symptoms (e.g., GP visits, hospitalisation, antibiotic prescription) during the 6 months post-vaccination | Baseline to 6 months post-vaccination |
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