DiabetesNCT03870997

Influenza Vaccination Digital Interventions for People Living With Diabetes

A study testing Diabetes Digital Intervention and Generic Digital Intervention in people with Diabetes, run by Evidation Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Diabetes
What is being tested?: Diabetes Digital Intervention and Generic Digital Intervention
Type of treatment: Vaccines, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 94,321 participants
Where: 1 siteUnited States
Study dates: 12 Sep 2018to 8 Apr 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

At least 18 years old
Lives in the U.S.

Who cannot join

< 18 years old
Does not live in the U.S.

Trial locations and contacts

1 site in 1 country.

United States1 site

Evidation Health
San Mateo, California, 94401

Other trials in United States

About this study

The overall objective of this prospective randomized controlled study is to assess and quantify the impact of digital interventions to increase vaccination rates and vaccination-related outcomes in a connected population with self-reported diabetes. The digital intervention will be delivered via a campaign sent to participants, with interventions varying with each study arm. Participants will be blinded to study participation status.

Conditions: Diabetes
Being tested: Diabetes Digital Intervention, Generic Digital Intervention
Medical subject headings: Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Diabetes Digital InterventionBehavioural
The Diabetes Digital Intervention is a digital campaign that provides interactive ways (e.g., videos, infographics, quizzes) for individuals to learn about influenza and related complications, and the importance of influenza vaccination. It is tailored to people living with diabetes and highlights the importance of influenza vaccination for this specific patient population.
Generic Digital InterventionBehavioural
The Generic Digital Intervention is a digital campaign that provides interactive ways (e.g., videos, infographics, quizzes) for individuals to learn about influenza and related complications, and the importance of influenza vaccination. It provides generic influenza vaccination interventions that can be applicable to any adult who should receive influenza vaccination.

Study groups in NCT03870997
Study group	Role	What they receive
Diabetes Digital Intervention	Experimental	Not described Receives: Behavioral: Diabetes Digital Intervention
Generic Digital Intervention	Experimental	Not described Receives: Behavioral: Generic Digital Intervention
No Influenza Vaccination Intervention	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Self-reported Influenza Vaccination in People With Diabetes
Number of participants with self-reported influenza vaccination in People With Diabetes: Intervention arm as compared to People With Diabetes: Control arm
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Sep 20188 Apr 2019

First posted12 Mar 2019
Study start12 Sep 2018
Primary completion8 Apr 2019
Study completion8 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 94,321 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03870997
Sponsor's protocol ID: EH-008
Status last verified: Jun 2020
First submitted: 7 Mar 2019
Last updated: 9 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Lee JL, Foschini L, Kumar S, Juusola J, Liska J, Mercer M, Tai C, Buzzetti R, Clement M, Cos X, Ji L, Kanumilli N, Kerr D, Montanya E, Muller-Wieland D, Ostenson CG, Skolnik N, Woo V, Burlet N, Greenberg M, Samson SI. 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.
PubMed 34535755

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

All Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Influenza Vaccination Digital Interventions for People Living With Diabetes
ClinicalTrials.gov ID: NCT03870997
Acronym / sponsor ID: EH-008
Conditions: Diabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 94,321 participants (actual)
Lead sponsor: Evidation HealthIndustry (pharma, biotech, devices)
Collaborators: Sanofi Pasteur, a Sanofi Company
Study start: 12 Sep 2018 (actual)
Primary completion: 8 Apr 2019 (actual)
Study completion: 8 Apr 2019 (actual)
First posted: 12 Mar 2019 (actual)
Results: Posted 4 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Diabetes Digital Intervention	Experimental	Behavioral: Diabetes Digital Intervention
Generic Digital Intervention	Experimental	Behavioral: Generic Digital Intervention
No Influenza Vaccination Intervention	No intervention	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

At least 18 years old
Lives in the U.S.

Key exclusion criteria (2 listed)

< 18 years old
Does not live in the U.S.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Diabetes Digital InterventionThe Diabetes Digital Intervention is a digital campaign that provides interactive ways (e.g., videos, infographics, quizzes) for individuals to learn about influenza and related complications, and the importance of influenza vaccination. It is tailored to people living with diabetes and highlights the importance of influenza vaccination for this specific patient population.	Behavioural	Diabetes Digital Intervention
Generic Digital InterventionThe Generic Digital Intervention is a digital campaign that provides interactive ways (e.g., videos, infographics, quizzes) for individuals to learn about influenza and related complications, and the importance of influenza vaccination. It provides generic influenza vaccination interventions that can be applicable to any adult who should receive influenza vaccination.	Behavioural	Generic Digital Intervention

Primary outcome

Number of Participants With Self-reported Influenza Vaccination in People With Diabetes
Time frame: 6 months
Number of participants with self-reported influenza vaccination in People With Diabetes: Intervention arm as compared to People With Diabetes: Control arm

Results and safety

Results posted to the registry on 4 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
People With Diabetes: Intervention	15,702	5,158
People With Diabetes: Control	15,702	5,271
Normal Controls-Similar: Intervention	15,756	4,778
Normal Controls-Similar: Control	15,757	4,810
Normal Controls: Intervention	15,702	5,114
Normal Controls: Controls	15,702	5,171

Primary outcome: Number of Participants With Self-reported Influenza Vaccination in People With Diabetes

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Diabetes Digital Intervention n = 10429
PWD: Intervention received influenza vaccine	3310
PWD: Intervention no influenza vaccine	1848
PWD: Control received influenza vaccine	3220
PWD: Control No influenza vaccine	2051

Population analysed: 5,158 in intervention group and 5,271 in control group

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
People With Diabetes: Intervention	0 of 0	0 of 0
People With Diabetes: Control	0 of 0	0 of 0
Normal Controls-Similar: Intervention	0 of 0	0 of 0
Normal Controls-Similar: Control	0 of 0	0 of 0
Normal Controls: Intervention	0 of 0	0 of 0
Normal Controls:Control	0 of 0	0 of 0

Limitations and caveats (from the sponsor): Study population may not be generalizable to the entire U.S. population with diabetes. Baseline vaccination rates were relatively high and population was generally aware of their health.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34535755Lee JL, Foschini L, Kumar S, Juusola J, Liska J, Mercer M, Tai C, Buzzetti R, Clement M, Cos X, Ji L, Kanumilli N, Kerr D, Montanya E, Muller-Wieland D, Ostenson CG, Skolnik N, Woo V, Burlet N, Greenberg M, Samson SI. 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.
Individual participant dataSharing planned: No

Related trials for Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Diabetes Digital Intervention and Generic Digital Intervention in people with Diabetes, run by Evidation Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Self-reported Influenza Vaccination in People With Diabetes (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03870997, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.