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Digital Health Intervention On Awareness Of Vaccination Against Influenza Among Adults With Diabetes

L

LabStyle Innovations

Status

Completed

Conditions

Diabetes
Diabetes Mellitus Self Management Education

Treatments

Behavioral: Previously studied based on RCT
Behavioral: Adapted Flu nudge messages

Study type

Observational

Funder types

Industry

Identifiers

NCT06840236
22166-01

Details and patient eligibility

About

The study leveraged the Dario digital health platform to retrospectively analyze data from 64,904 users with diabetes assigned by the platform into three groups: Group A received previously studied monthly flu nudge messages; Group B received an adapted intervention with 2-3 monthly messages; Group C served as the control with no intervention. Surveys were conducted at baseline, three months, and six months to assess vaccination status, awareness of influenza risks, and recollection of educational content. Statistical analyses, including logistic regression, Chi-square tests, and t-tests, were used to evaluate differences between groups.

Full description

The goal of this study was to retrospectively evaluate the effectiveness of an adapted digital nudge intervention that was designed previously in an RCT setting to increase influenza vaccination rates for PWD in real world setting. The primary objective was to examine the difference in self-reported influenza vaccination rates in three groups: PWD who received the intervention using a previously published approach (group A), PWD who received an adapted digital intervention (group B) and PWD who received no intervention (group C or control). A secondary aim was to investigate whether the intervention led to differences in awareness and knowledge across study groups and examined the relationship between awareness of influenza risks and vaccination rates.

The data was collected between September 2022 and March 2023 to evaluate the effectiveness of an adapted digital nudge intervention designed to increase influenza vaccination rates among people with diabetes (PWD) in a real-world setting. The intervention builds on a previously conducted randomized controlled trial (RCT). Users were automatically assigned to three groups via the customer engagement platform using a randomization algorithm to assign each selected user to one of the test variations. This ensured that each user had an equal chance of being placed in any of the groups.

The three groups are defined as follows: group A received flu nudge messages as described previously in a randomized clinical trial with one message given each month for six months; Group B received similar messages that were adapted in frequency with 2-3 messages per month for six months and matched the Dario platform's user experience; group C received no flu nudges (Control). No compensation was offered. The intervention messages included education and recommendations related to the importance of getting flu vaccination in the diabetes population.

Enrollment

8,431 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: subjects from the United States utilizing a Dario application who reported in the app during registration that they had a diagnosis of type 1 or 2 diabetes and who were active on the platform (logged into the app) during the 12-month period up to Sep 2022.

Exclusion Criteria: subjects that are not using Dario platform

Trial design

8,431 participants in 3 patient groups

Group B
Description:
Group B received similar messages that were adapted in frequency with 2-3 messages per month for six months and matched the Dario platform's user experience
Treatment:
Behavioral: Adapted Flu nudge messages
Group A
Description:
received flu nudge messages as described previously in a randomized clinical trial: "Lee JL et al. Digital intervention increases influenza vaccination rates for people with diabetes in a decentralized randomized trial. Npj Digit Med 2021 Sep 17;4(1):138. doi: 10.1038/s41746-021-00508-2"
Treatment:
Behavioral: Previously studied based on RCT
Group C
Description:
No Intervention regarding flu vaccination was provided

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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