N/A
Completed N=103
Mood and Influenza Vaccine Response: A Feasibility Trial
Vaccination; Infection
Source: ClinicalTrials.gov NCT03144518 ↗
Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcomePrimary: Mood Outcome Scores [Multiple] — 87.4; 79.8; 83.7; 79.8 score on a scale — p=.005
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mood Outcome Scores [Multiple] |
87.4; 79.8; 83.7; 79.8; 4.7; 4.0 | .005 sig |
| SECONDARY Recruitment |
23; 3; 103; 1002 | — |
| SECONDARY Attrition |
51; 51; 1; 0; 49; 48 | — |
| SECONDARY Secretory IgA Response |
81.0; 94.1; 116.7; 144.7 | .806 |
| SECONDARY Vaccine Specific IgG Response |
243.28; 208.81; 301.68; 284.96; 126.30; 127.25 | .438 |
| SECONDARY Health Care Utilization |
14; 13; 1; 1; 7; 3 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03144518). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.