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Incorporation of Safe Sleep Education Into m-Health Technology

Primary Purpose

Sudden Infant Death

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Safety in Seconds mobile app: Safe Sleep Education
Safety in Seconds mobile app: Car Seat Safety Education
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sudden Infant Death

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: English speaking caregivers over 18 of infants age 0-4 months Use a smart phone Exclusion Criteria: Non English speaking Under 18 years of age or unable to consent for themselves High acuity, critical care needs of infant patient that would limit participation during initial PED visit.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Safe Sleep Education

    Car seat safety

    Arm Description

    The intervention group will receive safe sleep education via the Safety in Seconds mobile app.

    The attention matched control group will receive car seat safety education via the Safety in Seconds mobile app.

    Outcomes

    Primary Outcome Measures

    Change in Safe sleep behaviors as assessed by survey developed by study team
    Safe sleep behaviors will be measured by the number of participants who adapt safe sleep behaviors.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 27, 2023
    Last Updated
    October 13, 2023
    Sponsor
    Johns Hopkins University
    Collaborators
    American SIDS Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06074211
    Brief Title
    Incorporation of Safe Sleep Education Into m-Health Technology
    Official Title
    Development and Incorporation of Safe Sleep Education Into m-Health Technology for the Pediatric Emergency Department
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2024 (Anticipated)
    Primary Completion Date
    April 2025 (Anticipated)
    Study Completion Date
    April 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johns Hopkins University
    Collaborators
    American SIDS Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Sudden Unexplained Infant Death (SUID) is the leading cause of death in infants age 28 days to 1 year. Protective factors, such as supine positioning, firm sleep surface, breastfeeding, pacifier use, elimination of soft objects from the sleep space, and avoidance of tobacco, alcohol, and illicit drugs have been shown to decrease the risk. The American Academy of Pediatrics recommends that healthcare providers model and convey safe sleep practices during patient encounters. Pediatric emergency departments (PED) serve as front-line contact for populations at greatest risk for SUID, however few interventions have been tested in the PED setting. M- Health (mobile health) apps have previously demonstrated the ability to deliver safety education to parents and are well suited for use in the PED given limited clinician time and long wait times. Safety in Seconds (SIS) is a theory based, m-Health injury prevention tool focused on care seat safety and fire safety with previously demonstrated effectiveness in an NIH-funded randomized trial. This study aims to add safe sleep education into the SIS, and subsequently disseminate the app in the PED setting. Integration of safe sleep education into SIS represents an opportunity to increase safe sleep knowledge and practices through a proven effective m-Health intervention. This study addresses this potential by incorporating a previously developed, theory-driven and evidence-based safe sleep education into the SIS app and testing the feasibility of deployment in the PED.
    Detailed Description
    More than 3500 children die annually in the US from Sudden Unexplained Infant Death (SUID) and sleep-related causes. Among the groups at highest risk for unsafe sleep behaviors and sleep-related infant mortality are racial and ethnic minorities, young mothers, and parents with substance use disorders. Safe sleep education is of great importance for the local community as infant mortality rates are notably high in Baltimore City. In 2017, Baltimore City's infant mortality rate was 1.3 times that of the state of Maryland and 1.5 times greater than the U.S. average. Of these deaths, 16.3% were related to sleep in Baltimore City compared to only 6.5% in the U.S. as a whole. Although attempts at integrating safe sleep education into health care visits have been met with varying success, the investigators have developed a theory- driven and evidence-based safe sleep intervention that increased safe sleep knowledge and practices. Given that rates of sleep-related deaths have plateaued in the past decade, new prevention strategies are needed. For instance, strategic use of technology-based approaches as well as targeted efforts in the pediatric emergency department (PED) setting merit consideration for several reasons. First, smartphones and mobile applications provide additional opportunities to disseminate health education to parents. M-Health (mobile health) education apps have demonstrated the ability to deliver safety education. However, the efficacy of mobile applications for increasing adherence to safe sleep recommendations has not been tested. Second, there is a growing emphasis on the need for prevention and health education in the emergency department. The emergency department is also particularly well suited for the employment of technology-based interventions, as clinicians have limited time to provide education while patients often face long wait times. In the Johns Hopkins PED, previous research has demonstrated high smartphone use, and acceptability of such interventions. Further, many SUID cases had in emergency departments visits prior to death, which represents a missed opportunity to intervene and educate families about safe sleep, making safe sleep education in the PED imperative. Finally, many urban PEDs, serve a population at high risk for infant mortality due to sociodemographic factors. To address these gaps and needs, this study proposes to adapt the Safety in Seconds (SIS) app to include safe sleep content and pilot test in the PED setting. The SIS app is a theory-based, m-Health tool that has been previously tested in the PED in an NIH-funded randomized trial that demonstrated its efficacy in improving appropriate car seat and smoke alarm knowledge and use. This app provides computer-generated, tailored messages to parents. There are three steps involved in the tool: (1) assessment; (2) data processing; and (3) feedback. Parents complete an assessment in the app and the answers are processed by a computer program to link each answer to specific theory-driven messages that are responsive to parents' reported beliefs and practices. These messages are used to produce a computer-generated, tailored report with persuasive and informative messages about safety topics. Building on this SIS app with proven effectiveness, the goal of this project is to incorporate evidence based, previously developed safe sleep education into the app and encourage implementation of safe sleep practices among families presenting to the PED. Aim 1: Digitize existing educational content on infant safe sleep recommendations and incorporate into the SIS app (following the previously utilized process for the current app content on car seat safety and fire safety). Aim 2: Pilot test the updated m-Health tool - SIS 2.0 - which incorporates new infant safe sleep content (from Aim 1) with existing injury prevention content on child passenger safety and fire safety. Feedback will be obtained from parents through follow-up surveys and interviews. Hypothesis: use of the SIS app for provision of safe sleep education will be effective in conveying this education.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sudden Infant Death

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Safe Sleep Education
    Arm Type
    Experimental
    Arm Description
    The intervention group will receive safe sleep education via the Safety in Seconds mobile app.
    Arm Title
    Car seat safety
    Arm Type
    Active Comparator
    Arm Description
    The attention matched control group will receive car seat safety education via the Safety in Seconds mobile app.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Safety in Seconds mobile app: Safe Sleep Education
    Intervention Description
    The Safety in Seconds mobile app is a platform previously developed to deliver targeted injury prevention education. This intervention will be testing the effectiveness of a newly developed educational module on safe sleep education.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Safety in Seconds mobile app: Car Seat Safety Education
    Intervention Description
    The Safety in Seconds mobile app is a platform previously developed to deliver targeted injury prevention education, including fire and car seat safety.
    Primary Outcome Measure Information:
    Title
    Change in Safe sleep behaviors as assessed by survey developed by study team
    Description
    Safe sleep behaviors will be measured by the number of participants who adapt safe sleep behaviors.
    Time Frame
    Baseline, 1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: English speaking caregivers over 18 of infants age 0-4 months Use a smart phone Exclusion Criteria: Non English speaking Under 18 years of age or unable to consent for themselves High acuity, critical care needs of infant patient that would limit participation during initial PED visit.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mary Beth Howard, MD, MSc
    Phone
    443-287-7207
    Email
    mhowar50@jh.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mary Beth Howard, MD, MSc
    Organizational Affiliation
    Johns Hopkins School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35726558
    Citation
    Moon RY, Carlin RF, Hand I; TASK FORCE ON SUDDEN INFANT DEATH SYNDROME AND THE COMMITTEE ON FETUS AND NEWBORN. Sleep-Related Infant Deaths: Updated 2022 Recommendations for Reducing Infant Deaths in the Sleep Environment. Pediatrics. 2022 Jul 1;150(1):e2022057990. doi: 10.1542/peds.2022-057990.
    Results Reference
    background
    PubMed Identifier
    32304589
    Citation
    Allen K, Anderson TM, Chajewska U, Ramirez JM, Mitchell EA. Factors associated with age of death in sudden unexpected infant death. Acta Paediatr. 2021 Jan;110(1):174-183. doi: 10.1111/apa.15308. Epub 2020 May 12.
    Results Reference
    background
    PubMed Identifier
    27918760
    Citation
    Carlin RF, Moon RY. Risk Factors, Protective Factors, and Current Recommendations to Reduce Sudden Infant Death Syndrome: A Review. JAMA Pediatr. 2017 Feb 1;171(2):175-180. doi: 10.1001/jamapediatrics.2016.3345.
    Results Reference
    background
    PubMed Identifier
    25898856
    Citation
    Canter J, Rao V, Patrick PA, Alpan G, Altman RL. The impact of a hospital-based educational video on maternal perceptions and planned practices of infant safe sleep. J Spec Pediatr Nurs. 2015 Jul;20(3):187-92. doi: 10.1111/jspn.12114. Epub 2015 Apr 21.
    Results Reference
    background
    PubMed Identifier
    28939661
    Citation
    McDonald EM, Davani A, Price A, Mahoney P, Shields W, Musci RJ, Solomon BS, Stuart EA, Gielen AC. Health education intervention promoting infant safe sleep in paediatric primary care: randomised controlled trial. Inj Prev. 2019 Jun;25(3):146-151. doi: 10.1136/injuryprev-2017-042421. Epub 2017 Sep 22.
    Results Reference
    background
    PubMed Identifier
    17671059
    Citation
    Gielen AC, McKenzie LB, McDonald EM, Shields WC, Wang MC, Cheng YJ, Weaver NL, Walker AR. Using a computer kiosk to promote child safety: results of a randomized, controlled trial in an urban pediatric emergency department. Pediatrics. 2007 Aug;120(2):330-9. doi: 10.1542/peds.2006-2703.
    Results Reference
    background
    PubMed Identifier
    11932115
    Citation
    Nansel TR, Weaver N, Donlin M, Jacobsen H, Kreuter MW, Simons-Morton B. Baby, Be Safe: the effect of tailored communications for pediatric injury prevention provided in a primary care setting. Patient Educ Couns. 2002 Mar;46(3):175-90. doi: 10.1016/s0738-3991(01)00211-7.
    Results Reference
    background

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    Incorporation of Safe Sleep Education Into m-Health Technology

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