Trial Outcomes & Findings for Mood and Influenza Vaccine Response: A Feasibility Trial (NCT NCT03144518)
NCT ID: NCT03144518
Last Updated: 2019-07-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
106 participants
Primary outcome timeframe
Baseline, Immediately Post Intervention (i.e, 15 minutes post-baseline).
Results posted on
2019-07-15
Participant Flow
Note: 3 Participants were not randomised to condition, as they did not attend primary session.
Participant milestones
| Measure |
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.
Positive Affect Intervention: See Previous Description
Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care): Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)
|
Active Control
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.
Neutral Control Intervention: See Previous Description
Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care): Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)
|
|---|---|---|
|
Primary Outcome (Mood)
STARTED
|
52
|
51
|
|
Primary Outcome (Mood)
COMPLETED
|
52
|
51
|
|
Primary Outcome (Mood)
NOT COMPLETED
|
0
|
0
|
|
4 Weeks Post-Vaccination
STARTED
|
52
|
51
|
|
4 Weeks Post-Vaccination
COMPLETED
|
51
|
51
|
|
4 Weeks Post-Vaccination
NOT COMPLETED
|
1
|
0
|
|
16 Week Post-Vaccination
STARTED
|
52
|
51
|
|
16 Week Post-Vaccination
COMPLETED
|
49
|
49
|
|
16 Week Post-Vaccination
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Missing Data count n=1
Baseline characteristics by cohort
| Measure |
Experimental
n=52 Participants
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.
Positive Affect Intervention: See Previous Description
Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care): Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)
|
Active Control
n=51 Participants
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.
Neutral Control Intervention: See Previous Description
Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care): Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.6 years
STANDARD_DEVIATION 4.6 • n=52 Participants • Missing Data count n=1
|
73.3 years
STANDARD_DEVIATION 5.1 • n=50 Participants • Missing Data count n=1
|
72.95 years
STANDARD_DEVIATION 4.87 • n=102 Participants • Missing Data count n=1
|
|
Sex: Female, Male
Female
|
22 Participants
n=52 Participants
|
30 Participants
n=51 Participants
|
52 Participants
n=103 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=52 Participants
|
21 Participants
n=51 Participants
|
51 Participants
n=103 Participants
|
|
Race/Ethnicity, Customized
White
|
51 Participants
n=52 Participants
|
48 Participants
n=51 Participants
|
99 Participants
n=103 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=52 Participants
|
1 Participants
n=51 Participants
|
1 Participants
n=103 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=52 Participants
|
1 Participants
n=51 Participants
|
2 Participants
n=103 Participants
|
|
Race/Ethnicity, Customized
Did not Respond
|
0 Participants
n=52 Participants
|
1 Participants
n=51 Participants
|
1 Participants
n=103 Participants
|
|
Marital Status
Married
|
34 Participants
n=52 Participants
|
29 Participants
n=51 Participants
|
63 Participants
n=103 Participants
|
|
Marital Status
Single, never married
|
0 Participants
n=52 Participants
|
3 Participants
n=51 Participants
|
3 Participants
n=103 Participants
|
|
Marital Status
Separated/divorced
|
9 Participants
n=52 Participants
|
4 Participants
n=51 Participants
|
13 Participants
n=103 Participants
|
|
Marital Status
Widowed
|
4 Participants
n=52 Participants
|
8 Participants
n=51 Participants
|
12 Participants
n=103 Participants
|
|
Marital Status
Cohabiting
|
3 Participants
n=52 Participants
|
3 Participants
n=51 Participants
|
6 Participants
n=103 Participants
|
|
Marital Status
Did not Respond
|
2 Participants
n=52 Participants
|
4 Participants
n=51 Participants
|
6 Participants
n=103 Participants
|
|
Highest Level of Education
School
|
37 Participants
n=52 Participants
|
40 Participants
n=51 Participants
|
77 Participants
n=103 Participants
|
|
Highest Level of Education
Undergraduate
|
2 Participants
n=52 Participants
|
0 Participants
n=51 Participants
|
2 Participants
n=103 Participants
|
|
Highest Level of Education
Postgraduate
|
0 Participants
n=52 Participants
|
1 Participants
n=51 Participants
|
1 Participants
n=103 Participants
|
|
Highest Level of Education
Other
|
8 Participants
n=52 Participants
|
8 Participants
n=51 Participants
|
16 Participants
n=103 Participants
|
|
Highest Level of Education
Did not respond
|
5 Participants
n=52 Participants
|
2 Participants
n=51 Participants
|
7 Participants
n=103 Participants
|
|
Independent Living
Yes
|
47 Participants
n=52 Participants
|
49 Participants
n=51 Participants
|
96 Participants
n=103 Participants
|
|
Independent Living
No
|
5 Participants
n=52 Participants
|
2 Participants
n=51 Participants
|
7 Participants
n=103 Participants
|
|
Highest Ever Total Household Income
≤ £14,999
|
17 Participants
n=52 Participants
|
16 Participants
n=51 Participants
|
33 Participants
n=103 Participants
|
|
Highest Ever Total Household Income
£15,000-£24,999
|
16 Participants
n=52 Participants
|
17 Participants
n=51 Participants
|
33 Participants
n=103 Participants
|
|
Highest Ever Total Household Income
£25,000-£34,999
|
8 Participants
n=52 Participants
|
4 Participants
n=51 Participants
|
12 Participants
n=103 Participants
|
|
Highest Ever Total Household Income
£35,000-£49,000
|
7 Participants
n=52 Participants
|
5 Participants
n=51 Participants
|
12 Participants
n=103 Participants
|
|
Highest Ever Total Household Income
£50,000-£74,999
|
1 Participants
n=52 Participants
|
2 Participants
n=51 Participants
|
3 Participants
n=103 Participants
|
|
Highest Ever Total Household Income
£75,000-£99,000
|
0 Participants
n=52 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=103 Participants
|
|
Highest Ever Total Household Income
≥ £100,000
|
0 Participants
n=52 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=103 Participants
|
|
Highest Ever Total Household Income
Did Not Respond
|
3 Participants
n=52 Participants
|
7 Participants
n=51 Participants
|
10 Participants
n=103 Participants
|
|
Current Smoker
|
4 Participants
n=52 Participants
|
4 Participants
n=51 Participants
|
8 Participants
n=103 Participants
|
|
Total Health Status
|
555.7 units on a scale
STANDARD_DEVIATION 175.1 • n=49 Participants • Missing Data Count: n=6
|
555.1 units on a scale
STANDARD_DEVIATION 169.9 • n=48 Participants • Missing Data Count: n=6
|
555.41 units on a scale
STANDARD_DEVIATION 171.62 • n=97 Participants • Missing Data Count: n=6
|
|
Trait Positive Affect
|
33.5 units on a scale
STANDARD_DEVIATION 8.6 • n=50 Participants • Missing Data Count: n=8
|
33.8 units on a scale
STANDARD_DEVIATION 8.1 • n=45 Participants • Missing Data Count: n=8
|
33.65 units on a scale
STANDARD_DEVIATION 8.33 • n=95 Participants • Missing Data Count: n=8
|
|
Trait Optimism
|
16.0 units on a scale
STANDARD_DEVIATION 4.8 • n=50 Participants • Missing Data Count: n=7
|
15.3 units on a scale
STANDARD_DEVIATION 4.5 • n=46 Participants • Missing Data Count: n=7
|
15.68 units on a scale
STANDARD_DEVIATION 4.61 • n=96 Participants • Missing Data Count: n=7
|
|
Trait Emotional Reactivity
|
39.9 units on a scale
STANDARD_DEVIATION 17.2 • n=47 Participants • Missing Data Count: n=8
|
41.3 units on a scale
STANDARD_DEVIATION 16.0 • n=48 Participants • Missing Data Count: n=8
|
40.59 units on a scale
STANDARD_DEVIATION 16.52 • n=95 Participants • Missing Data Count: n=8
|
|
Pre-Vaccination IgG
A/Michigan
|
187.2 ug/ml
STANDARD_DEVIATION 112.4 • n=52 Participants
|
156.6 ug/ml
STANDARD_DEVIATION 103.1 • n=51 Participants
|
172.05 ug/ml
STANDARD_DEVIATION 108.47 • n=103 Participants
|
|
Pre-Vaccination IgG
A/Hong-Kong
|
238.0 ug/ml
STANDARD_DEVIATION 119.9 • n=52 Participants
|
241.0 ug/ml
STANDARD_DEVIATION 158.1 • n=51 Participants
|
239.50 ug/ml
STANDARD_DEVIATION 139.42 • n=103 Participants
|
|
Pre-Vaccination IgG
B/Brisbane
|
107.0 ug/ml
STANDARD_DEVIATION 54.1 • n=52 Participants
|
118.9 ug/ml
STANDARD_DEVIATION 78.7 • n=51 Participants
|
112.90 ug/ml
STANDARD_DEVIATION 67.35 • n=103 Participants
|
|
Pre-Vaccination IgG
B/Phuket
|
144.4 ug/ml
STANDARD_DEVIATION 85.1 • n=52 Participants
|
183.2 ug/ml
STANDARD_DEVIATION 146.2 • n=51 Participants
|
163.61 ug/ml
STANDARD_DEVIATION 117.93 • n=103 Participants
|
|
Trait Negative Affect
|
15.2 units on a scale
STANDARD_DEVIATION 6.7 • n=49 Participants • Missing Data Count n=11
|
15.5 units on a scale
STANDARD_DEVIATION 6.4 • n=43 Participants • Missing Data Count n=11
|
15.35 units on a scale
STANDARD_DEVIATION 6.52 • n=92 Participants • Missing Data Count n=11
|
PRIMARY outcome
Timeframe: Baseline, Immediately Post Intervention (i.e, 15 minutes post-baseline).Population: Missing Data for some outcome measures - i.e., incomplete scale
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.
Outcome measures
| Measure |
Experimental
n=52 Participants
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.
Positive Affect Intervention: See Previous Description
Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care): Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)
|
Active Control
n=51 Participants
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.
Neutral Control Intervention: See Previous Description
Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care): Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)
|
|---|---|---|
|
Mood Outcome Scores [Multiple]
Post-Intervention VAS-Valence
|
87.4 score on a scale
Standard Deviation 15.7
|
79.8 score on a scale
Standard Deviation 20.8
|
|
Mood Outcome Scores [Multiple]
Post-Intervention VAS-Arousal
|
83.7 score on a scale
Standard Deviation 16.8
|
79.8 score on a scale
Standard Deviation 20.3
|
|
Mood Outcome Scores [Multiple]
Post-Intervention Pictorial Scale
|
4.7 score on a scale
Standard Deviation 1.1
|
4.0 score on a scale
Standard Deviation 1.5
|
|
Mood Outcome Scores [Multiple]
Post-Intervention PANAS Positive Affect
|
35.0 score on a scale
Standard Deviation 8.4
|
35.0 score on a scale
Standard Deviation 7.6
|
|
Mood Outcome Scores [Multiple]
Post-Intervention PANAS Negative Affect
|
11.1 score on a scale
Standard Deviation 3.0
|
11.4 score on a scale
Standard Deviation 2.3
|
|
Mood Outcome Scores [Multiple]
Pre-Intervention VAS-Valence
|
79.5 score on a scale
Standard Deviation 19.2
|
80.5 score on a scale
Standard Deviation 18.1
|
|
Mood Outcome Scores [Multiple]
Pre-Intervention VAS-Arousal
|
79.9 score on a scale
Standard Deviation 19.0
|
80.9 score on a scale
Standard Deviation 20.1
|
|
Mood Outcome Scores [Multiple]
Pre-Intervention Pictorial
|
3.7 score on a scale
Standard Deviation 1.5
|
4.0 score on a scale
Standard Deviation 1.5
|
|
Mood Outcome Scores [Multiple]
Pre-Intervention PANAS Postive Affect
|
34.3 score on a scale
Standard Deviation 7.2
|
34.6 score on a scale
Standard Deviation 35.0
|
|
Mood Outcome Scores [Multiple]
Pre-Intervention PANAS Negative Affect
|
12.3 score on a scale
Standard Deviation 4.0
|
12.3 score on a scale
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: BaselinePopulation: Total Population that received study Invitation
Recruitment rates to inform a future definitive trial
Outcome measures
| Measure |
Experimental
n=1131 Participants
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.
Positive Affect Intervention: See Previous Description
Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care): Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)
|
Active Control
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.
Neutral Control Intervention: See Previous Description
Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care): Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)
|
|---|---|---|
|
Recruitment
Expressed Interest, but not consented
|
23 Participants
|
—
|
|
Recruitment
Consented, but not randomised
|
3 Participants
|
—
|
|
Recruitment
Randomised
|
103 Participants
|
—
|
|
Recruitment
Did Not Express Interest
|
1002 Participants
|
—
|
SECONDARY outcome
Timeframe: 4 weeks (post-vaccination), 16 Weeks (post-vaccination)Attrition - to inform a future definitive trial
Outcome measures
| Measure |
Experimental
n=52 Participants
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.
Positive Affect Intervention: See Previous Description
Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care): Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)
|
Active Control
n=51 Participants
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.
Neutral Control Intervention: See Previous Description
Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care): Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)
|
|---|---|---|
|
Attrition
Attendance at 4 Week Follow-up · Yes
|
51 Participants
|
51 Participants
|
|
Attrition
Attendance at 4 Week Follow-up · No
|
1 Participants
|
0 Participants
|
|
Attrition
Attendance at 16 Week Follow up · Yes
|
49 Participants
|
48 Participants
|
|
Attrition
Attendance at 16 Week Follow up · No
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline, Immediately Post Intervention (i.e, 15 minutes post-baseline).Population: Missing Data Count n=15
Secretory IgA levels measured in saliva samples via ELISA. This is a non-specific measure of immunological response
Outcome measures
| Measure |
Experimental
n=46 Participants
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.
Positive Affect Intervention: See Previous Description
Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care): Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)
|
Active Control
n=42 Participants
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.
Neutral Control Intervention: See Previous Description
Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care): Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)
|
|---|---|---|
|
Secretory IgA Response
Pre-Intervention Flow Rate
|
81.0 Flow Rate (ug/min)
Standard Deviation 76.4
|
94.1 Flow Rate (ug/min)
Standard Deviation 94.2
|
|
Secretory IgA Response
Post-Intervention Flow Rate
|
116.7 Flow Rate (ug/min)
Standard Deviation 107.5
|
144.7 Flow Rate (ug/min)
Standard Deviation 142.5
|
SECONDARY outcome
Timeframe: 4 weeks (post-vaccination), 16 Weeks (post-vaccination)Population: Missing Data Count: n=1 for 4 weeks post-vaccination, n=5 for 16 weeks post-vaccination
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).
Outcome measures
| Measure |
Experimental
n=52 Participants
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.
Positive Affect Intervention: See Previous Description
Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care): Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)
|
Active Control
n=51 Participants
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.
Neutral Control Intervention: See Previous Description
Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care): Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)
|
|---|---|---|
|
Vaccine Specific IgG Response
16 Weeks Post-Vaccination A/Hong-Kong
|
283.67 ug/ml
Standard Deviation 126.72
|
288.75 ug/ml
Standard Deviation 180.18
|
|
Vaccine Specific IgG Response
4 Weeks Post-Vaccination A/Michigan
|
243.28 ug/ml
Standard Deviation 134.52
|
208.81 ug/ml
Standard Deviation 122.42
|
|
Vaccine Specific IgG Response
4 Weeks Post-Vaccination A/Hong-Kind
|
301.68 ug/ml
Standard Deviation 138.88
|
284.96 ug/ml
Standard Deviation 138.64
|
|
Vaccine Specific IgG Response
4 Weeks Post-Vaccination B/Brisbane
|
126.30 ug/ml
Standard Deviation 56.36
|
127.25 ug/ml
Standard Deviation 63.93
|
|
Vaccine Specific IgG Response
4 Weeks Post-Vaccination B/Phuket
|
210.30 ug/ml
Standard Deviation 123.96
|
229.57 ug/ml
Standard Deviation 135.63
|
|
Vaccine Specific IgG Response
16 Weeks Post-Vaccination A/Michigan
|
221.69 ug/ml
Standard Deviation 131.90
|
203.03 ug/ml
Standard Deviation 119.41
|
|
Vaccine Specific IgG Response
16 Weeks Post-Vaccination B/Brisbane
|
139.49 ug/ml
Standard Deviation 56.40
|
144.47 ug/ml
Standard Deviation 76.77
|
|
Vaccine Specific IgG Response
16 Weeks Post-Vaccination B/Phuket
|
249.10 ug/ml
Standard Deviation 124.90
|
271.70 ug/ml
Standard Deviation 176.16
|
SECONDARY outcome
Timeframe: Baseline to 6 months post-vaccinationVia 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
Outcome measures
| Measure |
Experimental
n=52 Participants
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.
Positive Affect Intervention: See Previous Description
Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care): Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)
|
Active Control
n=51 Participants
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.
Neutral Control Intervention: See Previous Description
Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care): Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)
|
|---|---|---|
|
Health Care Utilization
GP Consultations
|
14 Participants
|
13 Participants
|
|
Health Care Utilization
Nurse Consultations
|
1 Participants
|
1 Participants
|
|
Health Care Utilization
Out of Hours/Telephone Conversations
|
7 Participants
|
3 Participants
|
|
Health Care Utilization
Emergency Department Consultations
|
1 Participants
|
1 Participants
|
|
Health Care Utilization
Antibiotic Prescriptions
|
6 Participants
|
9 Participants
|
|
Health Care Utilization
Additional Investigations (e.g., Xray)
|
4 Participants
|
3 Participants
|
Adverse Events
Experimental
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place