NCT02908893

Brief Summary

The investigators design a 6-week messaging campaign aimed at promoting flu vaccination among fully insured members of a national payer that participate in a wellness program offered by the insurer through a mobile app. Outcomes measured will include uptake in flu vaccination rate as measured by the insurer and engagement with the campaign through the app. The goal of the research is to assess the effectiveness of pervasive computing messaging in promoting preventative care treatments such as flu shots. An additional goal is that of quantifying the importance of emphasizing incentives to increase efficacy of the messages.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
77,983

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 21, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

October 21, 2016

Status Verified

October 1, 2016

Enrollment Period

3 months

First QC Date

September 9, 2016

Last Update Submit

October 20, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • Increase in vaccination rate vs control

    Increase in vaccination rate of anyone messaged relative to the control condition

    Up to 1 week after the end of each of the three batches of the intervention (Oct 1/15/28 2016)

  • Increase in vaccination rate of salient vs non-salient

    Increase in vaccination rate of those who received salient incentives messages vs those who received generic messages

    Up to 1 week after the end of each of the three batches of the intervention (Oct 1/15/28 2016)

Secondary Outcomes (4)

  • Decrease in medically attended flu events of messaged vs control

    Up to 1 week after the end of each of the three batches of the intervention (Oct 1/15/28 2016)

  • Increase in reporting of flu vaccination through wellness app of salient vs non-salient

    Up to 1 week after the end of each of the three batches of the intervention (Oct 1/15/28 2016)

  • Increase in vaccination rate for users messaged within 2 days before of an expected rx pick-up.

    Up to 1 week after the end of each of the three batches of the intervention (Oct 1/15/28 2016)

  • Increase in message open rate of Salient vs Non-salient arm

    Up to 1 week after the end of each of the three batches of the intervention (Oct 1/15/28 2016)

Study Arms (3)

Salient

EXPERIMENTAL

Messages in the salient arm highlight the number of incentives (points) received by getting a flu shot and recording it through the wellness program app. Additionally, messages mention that flu shots can be received at the pharmacy while picking up an Rx. Users in the arm are matched up with a second user from the same arm, randomly. For each pair, the messages are sent to both users at the same time within the specified time window. Such time is picked to be the day in which the first user is most likely to pick up an Rx from a pharmacy.

Behavioral: In-app and push notification mobile messages

NonSalient

ACTIVE COMPARATOR

Messages in the non-salient arm highlight the benefits of getting vaccinated against flu, but make no mention of incentives received for getting vaccinated. Incentives would still be earned through the wellness program if the vaccination is recorded. Messages mention that flu shots can be received at the pharmacy while picking up an Rx. Users in the arm are matched up with a second user from the same arm, randomly. For each pair, the messages are sent to both users at the same time within the specified time window. Such time is picked to be the day in which the first user is most likely to pick up an Rx from a pharmacy

Behavioral: In-app and push notification mobile messages

Control

NO INTERVENTION

Users in this group will not receive any message promoting flu vaccination. Incentives would still be earned through the wellness program if the vaccination is recorded.

Interventions

Short messages (100-250 characters) are to be delivered to a mobile app both by push notification (i.e., appearing on the phone dashboard like a text message if the user has allowed notifications from the app) and in-app messages (visible in the news feed of the wellness program app when the app is opened). Messages contain a short title (30 characters) and 2-3 lines of text in the body (30 characters each).

NonSalientSalient

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • belongs to fully insured population
  • continuous health coverage between January 1, 2015 and June 1, 2016
  • has downloaded and installed the wellness platform app

You may not qualify if:

  • has declined the messaging from the platform

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evidation Health

Santa Barbara, California, 93101, United States

Location

Related Publications (1)

  • Lee WN, Stuck D, Konty K, Rivers C, Brown CR, Zbikowski SM, Foschini L. Large-scale influenza vaccination promotion on a mobile app platform: A randomized controlled trial. Vaccine. 2020 Apr 16;38(18):3508-3514. doi: 10.1016/j.vaccine.2019.11.053. Epub 2019 Nov 29.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Data Scientist

Study Record Dates

First Submitted

September 9, 2016

First Posted

September 21, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

October 21, 2016

Record last verified: 2016-10

Locations