CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 106 enrolled
Drug / intervention
Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care) +2 morebiological
Likely dose
Northern Hemisphere Influenza Vaccine 2017/18 (administered as part of standard care)AI-extracted
Key inclusion· 4
  • Age 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
Key exclusion· 10
  • Age <65 or >85 years
  • 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

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03144518
NCT03144518N/ACompleted

A Feasibility Trial of a Brief Positive Affect Intervention to Improve the Effectiveness of Influenza Vaccine Response in Older Adults.

University of Nottingham·interventional·Posted May 8, 2017·Updated Jul 15, 2019

In Brief

A clinical study evaluating Positive Affect Intervention, Neutral Control Intervention, and 1 other intervention for Vaccination; Infection. Completed, enrolled 106 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMay 8, 2017
Enrollment StartSep 1, 2017
Primary CompletionNov 1, 2017
Study CompletionMay 31, 2018
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 9.2 years ago

Interventions

Positive Affect Interventionother

See Previous Description

Neutral Control Interventionother

See Previous Description

Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)biological

Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)