Get Social Media and Risk-Reduction Training (GETSMART)

University of Virginia

Status: Enrolling

Conditions: Infant Death; Sudden Infant Death

Treatments: Behavioral: TodaysBaby

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06618586

202401227

R01HD110568-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study examines the implementation of the TodaysBaby™ mobile safe sleep intervention program in US hospitals. The main aims of this study are to examine: 1) differences in program penetration and the equity of penetration according to income and race/ethnicity; 2) differences in feasibility, acceptability, sustainability and fidelity top the intervention; and 3) the effectiveness of the intervention.

Enrollment: 10,000 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Must speak English or Spanish
• Must live in the United States
• Must have given birth to a healthy, term infants (37 weeks or greater) and be discharged within 7 days of birth
• Must plan to care for infant and live in the same household as infant after birth
• Must enroll in the TodaysBaby program by the time their infant is 7 days of age

Exclusion criteria

• A prenatal diagnosis expected to have impact on infant care practices not compatible with study goals, such as supine infant sleep positioning.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10,000 participants in 3 patient groups

New low touch (LT) hospital implementation strategy

Experimental group

Description:

This will occur during either the first or second 6-month intervention time period (order randomly assigned). For the period of time hospitals are randomized into this arm mothers will be attracted to TodaysBaby through direct-to-consumer marketing and sign themselves up using a QR code. These mothers will also receive standard postpartum care.

Treatment:

Behavioral: TodaysBaby

Original high touch (HT) hospital implementation strategy

Active Comparator group

Description:

This will occur during either the first or second 6-month intervention time period (order randomly assigned). For the period of time hospitals are randomized into this arm hospital staff will help mothers sign up and view the first 2 TodaysBaby in a one-on-one conversation format. These mothers will also receive standard postpartum care.

Treatment:

Behavioral: TodaysBaby

Control- Standard of Care

No Intervention group

Description:

During the 3 months immediately prior to the first intervention time period, hospitals will recruit approximately 100 mothers to complete surveys regarding infant care practices. These mothers will also receive postpartum standard of care.