Innovative mHealth Intervention providing Sustained Anticipatory Guidance (Zero Cavity): Design, Validation, User Perception, and Effectiveness
创新的移动医疗干预提供持续的预期指导(零腔):设计、验证、用户感知和有效性
基本信息
- 批准号:10740549
- 负责人:
- 金额:$ 14.08万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2023
- 资助国家:美国
- 起止时间:2023-09-15 至 2025-05-31
- 项目状态:未结题
- 来源:
- 关键词:AbscessAddressAdherenceAffectAgeAndroidArticulationAwarenessBehaviorBehavioralCalibrationCaregiversCaries preventionCaringCellular PhoneChildChild HealthChildhoodChronic DiseaseClinical TrialsCommunicationControl GroupsCountryDataDentalDental HygieneDental cariesDentistsDetectionDevelopmentDietDiseaseEarly identificationEffectivenessFathersFluoridesFocus GroupsFosteringGoalsGovernmentGuidelinesHealthHealth Care CostsHealth PersonnelHealth TechnologyHealth behaviorHealth educationHealth systemIncidenceIndiaInfantInternationalInterventionInterviewKnowledgeLeftLiteratureLondonMalnutritionMasticationMeasuresMethodsModelingMothersMotivationOralOral healthOutcome MeasurePainParentsParticipantPatient EducationPerceptionPerformancePersonsPhasePlanning TheoryPrevalencePreventionProbabilityProtocols documentationQualitative ResearchQuality of lifeRandomized, Controlled TrialsRegistriesReportingResearchResearch MethodologySchoolsScientistSpeechStructureSystemTelephoneTestingText MessagingTheoretical modelThinkingTimeValidationVisitVulnerable PopulationsWorkarmbehavior changebeneficiarycleft lip and palatecohortcompliance behaviorcost effectivecost effective interventiondensitydesigndigital healthdigital technologyearly childhoodeffectiveness evaluationeffectiveness testingevidence baseexperimental armfeedingfollow-upgeographic inaccessibilitygroup interventionhealth beliefhealth determinantshealth empowermenthigh rewardimprovedinnovationinterestlow and middle-income countrieslower income familiesmHealthmedical services inaccessibilitymobile applicationmotivational enhancement therapynovel strategiesoral carepediatricianpilot testpoor sleeppreventprimary outcomeprototyperecruitsatisfactionsecondary outcomeself esteemsleep behaviorsocialsocial exclusionsuccesstelehealthtooltooth surfaceusabilityuser-friendly
项目摘要
Project Summary
Early Childhood Caries (ECC), though preventable is the second most common chronic disease of childhood.
Recently, digital health has attracted substantial interest from the government particularly in low-middle-income
countries (LMIC) where mobile communication and telehealth has opened new possibilities for overcoming the
geographical inaccessibility of health care. Our preliminary work at the Centre for Early Childhood Caries
Research (CECCRe) using telephone calls, text messages, and providing age-appropriate infant oral care aids
collectively called Sustained Anticipatory Guidance (SAG) has shown promising results in infants with cleft lip
and palate recruited at pre dentate stage in preventing ECC. The feasibility and success of SAG have led to
ECC prevention up to 94%. We, therefore, propose to develop, validate, and test a novel approach of using a
mobile app to provide age-appropriate SAG to the parents. This approach is fundamentally different from the
traditional method of providing anticipatory guidance (AG) at the 6-monthly recall visits. In the R21 phase, we
will develop and test an interactive mobile app (Zero Cavity), grounded in Fisher Owen's model of children's
oral health determinants and the theory of planned behavior. Semi-structured interviews and focus group
discussion to explore awareness and practices and perceptions of oral health with relevant stakeholder groups
of parents, pediatricians and dentists and develop tailored guidance to the infant!s age and specific state of
oral development. We will use Design Thinking, 5De approach, and Nielsen Norman Guidelines to develop the
Zero cavity app prototype. In Aim 2, we will pilot test the Android and iOS versions of the app and evaluate
user perception using uMARS, CALO-RE scales. The R33 phase will be undertaken after the successful
completion of the R21 milestones. In Aim 3, we will establish 540 mother-child dyads and using an intent-to-
treat analysis to determine the effect of mobile app-assisted SAG protocol delivered through the Zero Cavity
app. Both intervention and control groups will receive baseline AG at the initial visit and at in-person 6-monthly
recalls. In addition, intervention group will receive SAG through the Zero cavity app between the in-person
visits. The trial will be carried out after registration in Clinical Trial Registry-India (CTRI) and adhering to
CONSORT guidelines. The R33 phase will culminate with an evaluation of effectiveness of the Zero Cavity app
in delivering SAG to mothers/fathers, thereby, preventing ECC. The secondary outcome (occurrence of ECC)
will be measured using International Caries Detection and Assessment System (ICDAS) by calibrated
examiners at 6 monthly intervals. The overall goal of this study is to develop, validate and test an interactive
mobile app (Zero Cavity) to deliver SAG to parents leading to a scalable cost-effective intervention preventing
ECC in LMIC countries.
项目摘要
儿童早期龋病(ECC)虽然是可以预防的,但却是儿童时期第二常见的慢性疾病。
最近,数字健康引起了政府特别是中低收入者的浓厚兴趣
移动通信和远程医疗为克服
卫生保健在地理上难以获得。我们在幼儿龋齿中心的初步工作
研究(CECCRe),使用电话、短信,并提供适合年龄的婴儿口腔护理辅助工具
统称为持续预期指导(SAG)的婴幼儿唇裂治疗显示出良好的效果。
并在齿前阶段招募上颌以预防ECC。SAG的可行性和成功导致了
ECC防御率高达94%。因此,我们建议开发、验证和测试一种使用
移动应用程序,为父母提供适合年龄的SAG。这种方法与
在6个月的召回访问中提供预见性指导(AG)的传统方法。在R21阶段,我们
将开发和测试一款交互式移动应用程序(Zero Cavity),基于费舍尔·欧文的儿童模型
口腔健康决定因素和计划行为理论。半结构化访谈和焦点小组
与相关利益相关群体讨论探讨口腔健康的意识、做法和看法
为家长、儿科医生和牙医制定量身定做的婴幼儿指导!S的年龄和具体情况
口腔发育。我们将使用设计思维、5DE方法和尼尔森·诺曼指南来开发
零腔APP原型。在Aim 2中,我们将对该应用程序的Android和iOS版本进行试点测试并进行评估
使用UMARS、CALO-RE量表的用户感知。R33阶段将在成功后进行
完成R21里程碑。在目标3中,我们将建立540个母子二元组,并使用意向-
手机APP辅助SAG方案零腔给药的疗效分析
应用程序。干预组和对照组都将在首次就诊时和6个月的面对面接受基线AG
召回。此外,干预组将通过零腔APP在面对面接受SAG
来访。该试验将在印度临床试验注册登记(CTRI)后进行,并遵守
配偶指南。R33阶段将以对零腔APP的有效性进行评估而告终
在将SAG传递给母亲/父亲方面,从而预防ECC。二次结局(ECC的发生)
将使用国际龋齿检测和评估系统(ICDAS)进行测量
审查员每隔6个月检查一次。本研究的总体目标是开发、验证和测试交互式
移动应用程序(零腔)为父母提供SAG,从而实现可扩展的经济高效的干预措施,防止
LMIC国家的ECC。
项目成果
期刊论文数量(0)
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