Trial Outcomes & Findings for Minnesota HealthSolutions Cellular Car Seat Study (NCT NCT05552027)
NCT ID: NCT05552027
Last Updated: 2024-09-19
Results Overview
For each misuse scenario participants will be asked to correct the error in the seat installation or the harness tension. Convertible seats will be used for this phase. For each scenario, we will use a huggable images test doll (age and weight of the doll will be indicated to participants). Study team will record seat direction (forward vs rear facing), harness tension (newtons), insecure attachment of the seat to the vehicle (yes/no).
COMPLETED
PHASE2
92 participants
Once during the only study visit: up to 30 mins
2024-09-19
Participant Flow
Participant milestones
| Measure |
Intervention
Participants will harness the car seat in 3 separate scenarios with the sensor system enabled to provide feedback.
CCS System- Prototype: Participants will be exposed to each of the 3 scenarios with the sensor system enabled (with feedback)
|
Control
Participants will harness the car seat in 3 separate scenarios with the sensor system disabled in order to not provide feedback.
CCS System- Control: The participants will be exposed to each of the 3 scenarios with the system disabled (no feedback).
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
46
|
|
Overall Study
COMPLETED
|
46
|
46
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Minnesota HealthSolutions Cellular Car Seat Study
Baseline characteristics by cohort
| Measure |
Intervention
n=46 Participants
Participants will harness the car seat in 3 separate scenarios with the sensor system enabled to provide feedback.
CCS System- Prototype: Participants will be exposed to each of the 3 scenarios with the sensor system enabled (with feedback)
|
Control
n=46 Participants
Participants will harness the car seat in 3 separate scenarios with the sensor system disabled in order to not provide feedback.
CCS System- Control: The participants will be exposed to each of the 3 scenarios with the system disabled (no feedback).
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
92 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
37 years
n=99 Participants
|
36 years
n=107 Participants
|
36 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=99 Participants
|
46 participants
n=107 Participants
|
92 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Once during the only study visit: up to 30 minsPopulation: Participants in the intervention group were given a study phone and asked to use the CCS smartphone app to complete the scenarios, while the control group was given only the paper manual that came with the safety seat. The misuse scenarios included A) a full safety seat installation with the convertible seat beginning on the floor, B) loose harness straps, and C) loose attachment to the vehicle seat at the base.
For each misuse scenario participants will be asked to correct the error in the seat installation or the harness tension. Convertible seats will be used for this phase. For each scenario, we will use a huggable images test doll (age and weight of the doll will be indicated to participants). Study team will record seat direction (forward vs rear facing), harness tension (newtons), insecure attachment of the seat to the vehicle (yes/no).
Outcome measures
| Measure |
Intervention - Scenario A
n=46 Participants
Sensor system enabled to provide feedback. Full seat installation.
|
Control - Scenario A
n=46 Participants
Sensor system disabled in order to not provide feedback. Full seat Installation.
|
Intervention - Scenario B
n=46 Participants
Sensor enabled to provide feedback. Harness straps left loose.
|
Control - Scenario B
n=46 Participants
Sensor system disabled in order to not provide feedback. Harness straps left loose.
|
Intervention - Scenario C
n=46 Participants
Sensor system enabled. Carseat left loose at the base.
|
Control - Scenario C
n=46 Participants
Sensor system disable to not provide feedback. Carseat left loose at the base.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Installation Errors
|
21 Participants
|
41 Participants
|
17 Participants
|
32 Participants
|
18 Participants
|
33 Participants
|
Adverse Events
Intervention
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place