Minnesota HealthSolutions Cellular Car Seat Study

Minnesota HealthSolutions

Status and phase: Completed; Phase 2

Conditions: Child Safety Seat Harness Tension

Treatments: Device: CCS System- Control; Device: CCS System- Prototype

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05552027

20-017790

Details and patient eligibility

About

The objective of the study is to evaluate an innovative child safety seat user engagement system (CCS system) designed to actively educate, instruct, and alarm caregivers with information associated with automatically-sensed safety seat misuses/errors via a smartphone application.

Full description

The primary objective of the study is to evaluate whether child safety seat users correct more critical misuse errors in child safety seat usage with the seat with the CCS system than the same seat with no sensor system. The CCS system will provide ongoing, tailored support to users at the time of an error. Videos will be available to users via a smartphone and provide short "how to" instructions that demonstrate how to correctly perform each safety seat behavior (e.g., tighten harness straps) and how to avoid common mistakes. The overall goal of the CCS system is to prevent child safety seat critical misuses and reduce deaths and injuries in children riding in motor vehicles. In the proposed study, adult participants will be asked to attend one in-person study visit and complete three (3) scenarios in which they will be asked to identify and correct errors in child safety seat use. Participants will be randomized to either the intervention group which will use the CCS system during each scenario or the control group which will not use the CCS system during each scenario.

Enrollment: 92 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Males or Females ages 18-75 years
• Has harnessed/fastened a child into a car seat in the last five (5) years
• Has a valid driver's license

Exclusion criteria

• Non-fluency in written and/or spoken English
• Participant cannot install a safety seat due to a physical or health limitation

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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92 participants in 2 patient groups

Intervention

Experimental group

Description:

Participants will harness the car seat in 3 separate scenarios with the sensor system enabled to provide feedback.

Treatment:

Device: CCS System- Prototype

Control

Other group

Description:

Participants will harness the car seat in 3 separate scenarios with the sensor system disabled in order to not provide feedback.

Treatment:

Device: CCS System- Control