NCT01892631

Brief Summary

Influenza morbidity and mortality cause a substantial financial burden to the NHS and to the UK as a whole. Influenza vaccine is safe and effective but is required annually because the circulating strain of virus changes each year. In the UK in 2012, the Chief Medical Officer (CMO) recommended that at least 75% of elderly people (aged 65+) and 75% people under 65 with certain chronic conditions (e.g. chronic heart disease, diabetes, asthma, etc) should be vaccinated. While primary care practices are achieving these targets for elderly patients, those set for younger patients with chronic conditions are not being met, with a third of patients being missed in the 2011/12 flu season and with no substantial improvements in uptake in the past decade. Therefore strategies to increase flu vaccine uptake in these patients are required. Previous trials have shown that patient reminders can increase vaccine uptake and in particular, text messaging has shown to work in some populations in the United States as a cheap, simple and effective reminder. However, whether the same is true in UK general practice is unclear. The use of text messaging in the NHS for appointment reminders is also increasing as it is cheap, quick and effective. Text messaging is already used in roughly 30% of practices to remind patients about their flu vaccine but there has been no trial addressing its effectiveness. Therefore, we propose a trial of a text messaging flu vaccine reminder in patients aged under 65 who have a chronic condition. We hypothesise that practices that send a text message will have increased flu vaccine uptake.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2013

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 4, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

October 24, 2016

Status Verified

December 1, 2015

Enrollment Period

2.2 years

First QC Date

June 13, 2013

Last Update Submit

October 21, 2016

Conditions

Keywords

Text messaging

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients at risk who received flu vaccine

    up to 9 months

Secondary Outcomes (4)

  • Proportion of practices reporting 'yes' to difficulties

    up to 3 months

  • Recruitment rate

    3 months after initial contact

  • Practice delivery of text message

    One month after study start (October 1st 2013)

  • Were outcome data available

    up to 9 months

Study Arms (2)

Standard care

OTHER

Practices in the standard care arm will proceed with their seasonal influenza campaign as planned.

Other: Standard care

Text messaging intervention

EXPERIMENTAL

Practices in the text messaging intervention arm will be asked to send a text message to patients under 65 at risk of influenza.

Other: Text message influenza vaccination reminder

Interventions

Practices in the text messaging intervention arm will be asked to send a text message to patients under 65 at risk of influenza.

Text messaging intervention

Practices in the standard care arm will be asked to proceed with their seasonal influenza campaign as planned.

Standard care

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • practices must use text messaging software to communicate with patients;
  • practices must not have used a text message to remind patients aged under 65 about influenza vaccine in the 2012/13 influenza season.
  • practices will send the text message to eligible patients who are aged between 18 and 65, with one of the following risk conditions: chronic respiratory disease, chronic liver disease, chronic kidney disease, chronic heart disease, chronic neurological disease, immunosuppression

You may not qualify if:

  • practices will not send the text message to pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London School of Hygiene and Tropical Medicine

London, Select County, WC1E 7HT, United Kingdom

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2013

First Posted

July 4, 2013

Study Start

September 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

October 24, 2016

Record last verified: 2015-12

Locations