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
About this trial
This is an interventional prevention trial for Sudden Infant Death
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.
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
NCT ID
NCT06074211
First Posted
September 27, 2023
Last Updated
October 13, 2023
Sponsor
Johns Hopkins University
Collaborators
American SIDS Institute
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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