Diabetes
Conditions
Brief summary
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.
Interventions
BEHAVIORALDiabetes Digital Intervention
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.
BEHAVIORALGeneric Digital Intervention
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.
Sponsors
Sanofi Pasteur, a Sanofi Company
Evidation Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* At least 18 years old * Lives in the U.S.
Exclusion criteria
* \< 18 years old * Does not live in the U.S.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Self-reported Influenza Vaccination in People With Diabetes | 6 months | Number of participants with self-reported influenza vaccination in People With Diabetes: Intervention arm as compared to People With Diabetes: Control arm |
Countries
United States
Participant flow
Recruitment details
Existing members of the online health platform Achievement who met the inclusion criteria were blinded to their study participation status and were not asked to take any action to enroll in the study. Participants were randomized to one of the digital interventions or to no intervention. All study activities were conducted virtually.
Participants by arm
| Arm | Count |
|---|---|
| People With Diabetes:Intervention Participant demographics | 5,158 |
| People With Diabetes: Control Participant demographics | 5,271 |
| Normal Controls-Similar: Intervention Participant demographics | 4,778 |
| Normal Controls-Similar : Control Participant demographics | 4,810 |
| Normal Controls: Intervention Participant demographics | 5,114 |
| Normal Controls: Control Participant demographics | 5,171 |
| Total | 30,302 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Did not complete mid-study/final survey | 10,544 | 10,431 | 10,978 | 10,947 | 10,588 | 10,531 |
Baseline characteristics
| Characteristic | Normal Controls: Intervention | Normal Controls: Control | Total | People With Diabetes: Control | Normal Controls-Similar: Intervention | People With Diabetes:Intervention | Normal Controls-Similar : Control |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 46.2 years STANDARD_DEVIATION 12.6 | 46.6 years STANDARD_DEVIATION 11.7 | 46.6 years STANDARD_DEVIATION 11.8 | 46.7 years STANDARD_DEVIATION 11.2 | 46.8 years STANDARD_DEVIATION 12.4 | 46.8 years STANDARD_DEVIATION 11.1 | 46.4 years STANDARD_DEVIATION 12.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 33 Participants | 25 Participants | 8249 Participants | 4141 Participants | 33 Participants | 3990 Participants | 27 Participants |
| Race (NIH/OMB) Asian | 174 Participants | 144 Participants | 1468 Participants | 451 Participants | 114 Participants | 468 Participants | 117 Participants |
| Race (NIH/OMB) Black or African American | 238 Participants | 245 Participants | 1271 Participants | 53 Participants | 319 Participants | 50 Participants | 366 Participants |
| Race (NIH/OMB) More than one race | 243 Participants | 206 Participants | 1200 Participants | 134 Participants | 221 Participants | 137 Participants | 259 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 12 Participants | 8 Participants | 371 Participants | 169 Participants | 10 Participants | 163 Participants | 9 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 105 Participants | 90 Participants | 1014 Participants | 305 Participants | 87 Participants | 331 Participants | 96 Participants |
| Race (NIH/OMB) White | 4309 Participants | 4453 Participants | 16729 Participants | 18 Participants | 3994 Participants | 19 Participants | 3936 Participants |
| Region of Enrollment United States | 5114 participants | 5171 participants | 30302 participants | 5271 participants | 4778 participants | 5158 participants | 4810 participants |
| Sex/Gender, Customized Sex, Female | 4052 Participants | 4029 Participants | 23873 Participants | 4183 Participants | 3747 Participants | 4048 Participants | 3814 Participants |
| Sex/Gender, Customized Sex, Male | 1051 Participants | 1128 Participants | 6335 Participants | 1066 Participants | 1014 Participants | 1096 Participants | 980 Participants |
| Sex/Gender, Customized Sex, Other | 11 Participants | 14 Participants | 94 Participants | 22 Participants | 17 Participants | 14 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
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
Time frame: 6 months
Population: 5,158 in intervention group and 5,271 in control group
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Diabetes Digital Intervention | Number of Participants With Self-reported Influenza Vaccination in People With Diabetes | PWD: Intervention received influenza vaccine | 3310 Participants |
| Diabetes Digital Intervention | Number of Participants With Self-reported Influenza Vaccination in People With Diabetes | PWD: Intervention no influenza vaccine | 1848 Participants |
| Diabetes Digital Intervention | Number of Participants With Self-reported Influenza Vaccination in People With Diabetes | PWD: Control received influenza vaccine | 3220 Participants |
| Diabetes Digital Intervention | Number of Participants With Self-reported Influenza Vaccination in People With Diabetes | PWD: Control No influenza vaccine | 2051 Participants |