Trial Outcomes & Findings for Influenza Vaccination Digital Interventions for People Living With Diabetes (NCT NCT03870997)

Last Updated: 2020-06-09

Results Overview

Number of participants with self-reported influenza vaccination in People With Diabetes: Intervention arm as compared to People With Diabetes: Control arm

Recruitment status

COMPLETED

Study phase

Target enrollment

94321 participants

Primary outcome timeframe

6 months

Results posted on

2020-06-09

Participant Flow

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.

Participant milestones

Participant milestones
Measure	People With Diabetes: Intervention Individuals with self-reported diabetes who receive the Diabetes Digital Intervention	People With Diabetes: Control Individuals with self-reported diabetes who received no digital intervention	Normal Controls-Similar: Intervention Individuals without self-reported diabetes who were similar to PWD based on demographics and activity tracker data and received the Generic Digital Intervention	Normal Controls-Similar: Control Individuals without self-reported diabetes who were similar to PWD based on demographics and activity tracker data and received no digital intervention	Normal Controls: Intervention Individuals without self-reported diabetes and were not in NC-S based on demographics and activity tracker data, but were similar to PWD with regards to age and gender distribution and received the Generic Digital Intervention	Normal Controls: Controls Individuals without self-reported diabetes and were not in NC-S based on demographics and activity tracker data, but were similar to PWD with regards to age and gender distribution and received no Digital Intervention
Overall Study STARTED	15702	15702	15756	15757	15702	15702
Overall Study COMPLETED	5158	5271	4778	4810	5114	5171
Overall Study NOT COMPLETED	10544	10431	10978	10947	10588	10531

Reasons for withdrawal

Reasons for withdrawal
Measure	People With Diabetes: Intervention Individuals with self-reported diabetes who receive the Diabetes Digital Intervention	People With Diabetes: Control Individuals with self-reported diabetes who received no digital intervention	Normal Controls-Similar: Intervention Individuals without self-reported diabetes who were similar to PWD based on demographics and activity tracker data and received the Generic Digital Intervention	Normal Controls-Similar: Control Individuals without self-reported diabetes who were similar to PWD based on demographics and activity tracker data and received no digital intervention	Normal Controls: Intervention Individuals without self-reported diabetes and were not in NC-S based on demographics and activity tracker data, but were similar to PWD with regards to age and gender distribution and received the Generic Digital Intervention	Normal Controls: Controls Individuals without self-reported diabetes and were not in NC-S based on demographics and activity tracker data, but were similar to PWD with regards to age and gender distribution and received no Digital Intervention
Overall Study Did not complete mid-study/final survey	10544	10431	10978	10947	10588	10531

Baseline Characteristics

Influenza Vaccination Digital Interventions for People Living With Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	People With Diabetes:Intervention n=5158 Participants Participant demographics	People With Diabetes: Control n=5271 Participants Participant demographics	Normal Controls-Similar: Intervention n=4778 Participants Participant demographics	Normal Controls-Similar : Control n=4810 Participants Participant demographics	Normal Controls: Intervention n=5114 Participants Participant demographics	Normal Controls: Control n=5171 Participants Participant demographics	Total n=30302 Participants Total of all reporting groups
Age, Continuous	46.8 years STANDARD_DEVIATION 11.1 • n=39 Participants	46.7 years STANDARD_DEVIATION 11.2 • n=41 Participants	46.8 years STANDARD_DEVIATION 12.4 • n=35 Participants	46.4 years STANDARD_DEVIATION 12.6 • n=31 Participants	46.2 years STANDARD_DEVIATION 12.6 • n=146 Participants	46.6 years STANDARD_DEVIATION 11.7 • n=19 Participants	46.6 years STANDARD_DEVIATION 11.8 • n=147 Participants
Sex/Gender, Customized Sex, · Female	4048 Participants n=39 Participants	4183 Participants n=41 Participants	3747 Participants n=35 Participants	3814 Participants n=31 Participants	4052 Participants n=146 Participants	4029 Participants n=19 Participants	23873 Participants n=147 Participants
Sex/Gender, Customized Sex, · Male	1096 Participants n=39 Participants	1066 Participants n=41 Participants	1014 Participants n=35 Participants	980 Participants n=31 Participants	1051 Participants n=146 Participants	1128 Participants n=19 Participants	6335 Participants n=147 Participants
Sex/Gender, Customized Sex, · Other	14 Participants n=39 Participants	22 Participants n=41 Participants	17 Participants n=35 Participants	16 Participants n=31 Participants	11 Participants n=146 Participants	14 Participants n=19 Participants	94 Participants n=147 Participants
Race (NIH/OMB) American Indian or Alaska Native	3990 Participants n=39 Participants	4141 Participants n=41 Participants	33 Participants n=35 Participants	27 Participants n=31 Participants	33 Participants n=146 Participants	25 Participants n=19 Participants	8249 Participants n=147 Participants
Race (NIH/OMB) Asian	468 Participants n=39 Participants	451 Participants n=41 Participants	114 Participants n=35 Participants	117 Participants n=31 Participants	174 Participants n=146 Participants	144 Participants n=19 Participants	1468 Participants n=147 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	163 Participants n=39 Participants	169 Participants n=41 Participants	10 Participants n=35 Participants	9 Participants n=31 Participants	12 Participants n=146 Participants	8 Participants n=19 Participants	371 Participants n=147 Participants
Race (NIH/OMB) Black or African American	50 Participants n=39 Participants	53 Participants n=41 Participants	319 Participants n=35 Participants	366 Participants n=31 Participants	238 Participants n=146 Participants	245 Participants n=19 Participants	1271 Participants n=147 Participants
Race (NIH/OMB) White	19 Participants n=39 Participants	18 Participants n=41 Participants	3994 Participants n=35 Participants	3936 Participants n=31 Participants	4309 Participants n=146 Participants	4453 Participants n=19 Participants	16729 Participants n=147 Participants
Race (NIH/OMB) More than one race	137 Participants n=39 Participants	134 Participants n=41 Participants	221 Participants n=35 Participants	259 Participants n=31 Participants	243 Participants n=146 Participants	206 Participants n=19 Participants	1200 Participants n=147 Participants
Race (NIH/OMB) Unknown or Not Reported	331 Participants n=39 Participants	305 Participants n=41 Participants	87 Participants n=35 Participants	96 Participants n=31 Participants	105 Participants n=146 Participants	90 Participants n=19 Participants	1014 Participants n=147 Participants
Region of Enrollment United States	5158 participants n=39 Participants	5271 participants n=41 Participants	4778 participants n=35 Participants	4810 participants n=31 Participants	5114 participants n=146 Participants	5171 participants n=19 Participants	30302 participants n=147 Participants

PRIMARY outcome

Timeframe: 6 months

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

Number of participants with self-reported influenza vaccination in People With Diabetes: Intervention arm as compared to People With Diabetes: Control arm