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Make Safe Happen App Evaluation Study

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ClinicalTrials.gov Identifier: NCT02751203
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Lara McKenzie, Nationwide Children's Hospital

Brief Summary:

Unintentional injury is the leading cause of death for young children in the United States (U.S.) and is responsible for more child deaths than they next three causes combined, that is, homicide, suicide, and cancer. Each year approximately 9,000 children die, 250,000 are hospitalized and more than 9,000,000 children are treated in emergency departments for preventable injuries. Child and adolescent unintentional injury deaths have not declined to the same extent that other diseases have, and resources directed at reducing child injury are not commensurate with the burden it poses. More than 50% of these injuries occur in and around the home, where young children spend most of their time.

Unlike diseases such as cancer, there is no need to wait on a cure...there already is one. Many of these injuries can be prevented through the use of safety equipment and by following safety recommendations. Using known, effective countermeasures can prevent or reduce the consequences of a child being injured yet these devices are not routinely utilized. Barriers related to identifying hazards, finding credible information and recommendations, and obtaining the safety products best-suited to the features of your home make creating a safe home challenging for caregivers. Interventions for increasing home safety behaviors have ranged from educational materials, health care provider counseling, safety product distribution, hands-on experiential learning in a safety resource center--these have all been evaluated with varying degrees of effectiveness, however, wide-reaching interventions to reach large/substantial caregiver audiences, are needed. Offering tailored safety information on multiple topics via a single platform, combined with the ability to acquire safety devices, is a more efficient means to reach a large segment of the population and may help reduce the aforementioned barriers.

Thus, there is an urgent need for mobile technologies to reduce barriers by helping parents identify injury hazards in their homes, consolidate credible injury prevention recommendations, organize information by room or feature, tailor by child age, facilitate the acquisition and installation of safety products, encourage and track progress, thereby increasing the likelihood that parents accomplish these important life-saving safety tasks.


Condition or disease Intervention/treatment Phase
Health Knowledge,Practices,Attitudes Behavioral: Make Safe Happen App Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5085 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Make Safe Happen App Evaluation Study
Study Start Date : April 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: Make Safe Happen App Intervention
Pre- and post-test delivered to online survey panel participants. Instruction to download and use the intervention (Make Safe Happen Mobile App) for 1 week.
Behavioral: Make Safe Happen App
The Make Safe Happen app is a mobile app (available for free download android and iOS) developed by the safety experts in the Center for Injury Research and Policy. Parents and caregivers can use the app to learn how to make their homes safer with room-to-room safety checklists and links to recommended products. App users can also create to-do lists, set reminders and track their progress.

No Intervention: Make Safe Happen App Control
A subset of online survey panel participants (n=200) will complete a pre- and post-test survey but will receive a non-safety app (e.g. a free recipe app). After the study, participants will be asked to download the intervention app.



Primary Outcome Measures :
  1. Safety Knowledge Score [ Time Frame: 2 weeks ]
    A safety knowledge score will be calculated by summing the number of correct answers collected from 10-12 questions regarding the participant's safety knowledge. These will be asked at both the pre and post test. Scores will be compared over time and between groups.


Secondary Outcome Measures :
  1. Behavioral Intention assessed by using the Health Belief Model [ Time Frame: 2 weeks ]
    A series of questions (10-15) developed with the use of the Health Belief Model will be asked to access the change in behavior intention. Questions will be asked at the pre and post tests and compared over time and between groups.


Other Outcome Measures:
  1. Number of safety devices [ Time Frame: 2 weeks ]
    Participants will complete an inventory of the safety devices they have installed or use in their home during the pre and post tests. Number of safety products will be compared over time and between groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • have a smart phone (iOS or Android)
  • have willingness to download and install a free mobile application
  • parents must be comfortable answering questions online, in English
  • parent or legal guardian (male or female) of a child 0-12 years, who lives with them most of the time.

Exclusion Criteria:

  • have previously downloaded or used the Make Safe Happen® app.
  • have participated in other parts of the study (ie.Online survey participants will not be eligible for participation in the parent focus groups or home observations).

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lara McKenzie, Principal Investigator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02751203     History of Changes
Other Study ID Numbers: IRB16-00119
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No