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Make Safe Happen App Evaluation Study

2018年1月23日 更新者:Lara McKenzie

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.

調査の概要

詳細な説明

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 the 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 (at a cost of around $87 billion in medical and societal costs). Child and adolescent unintentional injury deaths have not declined to the same extent as 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. Common causes of fatal and non-fatal unintentional childhood injuries include: fires and burns, falls, drowning, poisoning, and suffocation. For example, residential fires account for nearly 90 percent of all fire-related deaths. Almost 13,000 children are injured by TV tip-overs each year. Medications are the leading causes of child poisoning. Finally, other home hazards include bunk beds, high chairs, windows, stoves and ovens, button batteries, laundry packets, and toys-ubiquitous products and home features present in nearly every U.S. home.

Unlike diseases such as cancer, there is no need to wait on a cure...there already is one. Many of the injuries can be prevented through the use of safety equipment and by following safety recommendations. Using known, effective countermeasures, namely, smoke alarms, carbon monoxide detectors, stair gates, cabinet locks and latches, and anchoring TV and furniture can prevent or reduce the consequences of a child being injured. Unfortunately, overall the rates for these safety behaviors vary/are low (add a citation). Barriers related to identifying hazards, finding credible information and recommendations, and obtaining the safety products best-suited to the features of a home make creating a safe home difficult for parents and caregivers. Interventions for increasing home safety behaviors have ranged from the provision of educational materials, to health care provider counseling, safety product distribution, hands-on experiential learning provided in safety resource centers have been evaluated (with varying degrees of effectiveness), however, wide-reaching interventions, to reach large/substantial parent and 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-that is, programs using mobile phone or tablet, including apps and text messaging, or portable devices to deliver an intervention-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 and life-saving safety tasks. Our long-term goal is to prevent or reduce the consequences of home-related child injuries. The overall objective of this proposed research, which is the next step toward attainment of our long-term goal, is to preliminarily evaluate a mobile technology-based health behavior change intervention, the Make Safe Happen® app, for improving knowledge and behavior for the prevention of unintentional child injuries. Our central hypothesis is that parents will have increased safety knowledge and more safety behaviors (self-reported and observed), and higher behavioral intention to make their homes safer after utilizing the Make Safe Happen® app compared to a control group. The rationale that underlies the proposed research is derived from the Health Belief Model (HBM) which explains that an individual's perceptions of a threat posed by a health problem (susceptibility, severity), the benefits of avoiding the threat (perceived benefits), and factors influencing the decision to act (barriers, cues to action, and self-efficacy) effect their decision about whether to take action to avoid injury or illness (National Cancer Institute 2005). The investigators plan to objectively test our central hypothesis and, thereby, attain the objective of this application by pursuing the following specific aims:

Specific Aim 1. Determine whether a mobile technology-based health behavior change intervention, the Make Safe Happen® app is effective in improving safety knowledge for the prevention of unintentional child home-related injuries, compared with no intervention. Our working hypothesis is that parents and caregivers receiving the intervention will have greater safety knowledge than parents and caregivers in the control group.

Specific Aim 2. Determine whether a mobile technology-based health behavior change intervention, the Make Safe Happen® app is effective in increasing behavioral intention for the prevention of unintentional child home-related injuries, compared with no intervention or alternate interventions. Our working hypothesis is that parents and caregivers reporting higher behavioral intention will be more likely to complete tasks related to "childproofing" or "safety proofing" their homes.

Specific Aim 3. Preliminarily investigate whether a mobile technology-based health behavior change intervention, the Make Safe Happen® app is effective in improving safety behaviors, acquisition and use of safety devices for the prevention of unintentional child home-related injuries, compared with no intervention.

Possible Exploratory Sub-Aims Sub-aim #1. Evaluate race and ethnicity as a potentially important modifier of the impact of the intervention.

Sub-aim #2: Evaluate household income as a potentially important modifier of the impact of the intervention.

Sub-aim #3: notifications [NOTE: if app use period is only 1 week long, they will not naturally receive notifications as they are currently proposed] Sub-aim #4: e-health literacy (defined as the ability to seek, find, understand, and appraise health information from electronic sources and apply the knowledge gained to addressing or solving a health problem)(Norman and Skinner 2006)

It is anticipated that these aims will yield the following expected outcomes. First, the investigators expect to determine the effect of the intervention on parents' safety knowledge, thereby demonstrating the utility of a mobile app for future unintentional child home-related injury prevention. Second, the investigators expect to learn whether the intervention increases behavioral intention to complete home safety behaviors and safety device acquisition. Third, the investigators will explore whether the intervention increases safety behaviors, acquisition and use of safety devices. In an exploratory aim the investigators will begin to assess whether the intervention is adopted differently among parents of varying races/ethnicities, which will suggest opportunities for tailoring the intervention to maximize its impact. Next, the investigators will have established a link between parents' behavioral intention related to home injury prevention behaviors and device use, which will inform future prevention efforts and expansion of the Make Safe Happen® program and app. Finally, the investigators will provide new insights into the synergism between caring for young children and providing them a safe home environment free of hazards. These outcomes are expected to have an important positive impact because providing a safe home environment has the potential to prevent or reduce unintentional child injuries and deaths, as will now be detailed in the next section.

研究の種類

介入

入学 (実際)

5085

段階

  • 適用できない

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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).

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:他の
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
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.
介入なし: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Safety Knowledge Score
時間枠: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.
2 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Behavioral Intention assessed by using the Health Belief Model
時間枠: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.
2 weeks

その他の成果指標

結果測定
メジャーの説明
時間枠
Number of safety devices
時間枠: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.
2 weeks

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2016年4月1日

一次修了 (実際)

2017年12月1日

研究の完了 (実際)

2017年12月1日

試験登録日

最初に提出

2016年3月28日

QC基準を満たした最初の提出物

2016年4月21日

最初の投稿 (見積もり)

2016年4月26日

学習記録の更新

投稿された最後の更新 (実際)

2018年1月25日

QC基準を満たした最後の更新が送信されました

2018年1月23日

最終確認日

2018年1月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • IRB16-00119

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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