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

• 批准号: 10740549
• 负责人: Vineet K. Dhar
• 金额: $ 14.08万
• 依托单位: SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH TRUST
• 依托单位国家: 美国
• 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: https://reporter.nih.gov/project-details/10740549
• 关键词: Abscess; Address; Adherence; Affect; Age; Android; Articulation; Awareness; Behavior; Behavioral; Calibration; Caregivers; Caries prevention; Caring; Cellular Phone; Child; Child Health; Childhood; Chronic Disease; Clinical Trials; Communication; Control Groups; Country; Data; Dental; Dental Hygiene; Dental caries; Dentists; Detection; Development; Diet; Disease; Early identification; Effectiveness; Fathers; Fluorides; Focus Groups; Fostering; Goals; Government; Guidelines; Health; Health Care Costs; Health Personnel; Health Technology; Health behavior; Health education; Health system; Incidence; India; Infant; International; Intervention; Interview; Knowledge; Left; Literature; London; Malnutrition; Mastication; Measures; Methods; Modeling; Mothers; Motivation; Oral; Oral health; Outcome Measure; Pain; Parents; Participant; Patient Education; Perception; Performance; Persons; Phase; Planning Theory; Prevalence; Prevention; Probability; Protocols documentation; Qualitative Research; Quality of life; Randomized, Controlled Trials; Registries; Reporting; Research; Research Methodology; Schools; Scientist; Speech; Structure; System; Telephone; Testing; Text Messaging; Theoretical model; Thinking; Time; Validation; Visit; Vulnerable Populations; Work; arm; behavior change; beneficiary; cleft lip and palate; cohort; compliance behavior; cost effective; cost effective intervention; density; design; digital health; digital technology; early childhood; effectiveness evaluation; effectiveness testing; evidence base; experimental arm; feeding; follow-up; geographic inaccessibility; group intervention; health belief; health determinants; health empowerment; high reward; improved; innovation; interest; low and middle-income countries; lower income families; mHealth; medical services inaccessibility; mobile application; motivational enhancement therapy; novel strategies; oral care; pediatrician; pilot test; poor sleep; prevent; primary outcome; prototype; recruit; satisfaction; secondary outcome; self esteem; sleep behavior; social; social exclusion; success; telehealth; tool; tooth surface; usability; user-friendly

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.

项目概要 儿童早期龋齿 (ECC) 虽然可以预防，但却是儿童期第二常见的慢性疾病。 最近，数字医疗引起了政府的极大兴趣，特别是在中低收入国家 移动通信和远程医疗为克服这些问题提供了新的可能性的国家（中低收入国家） 地理上难以获得医疗保健。我们在儿童早期龋齿中心的前期工作 使用电话、短信进行研究 (CECCRe)，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）的方法在唇裂婴儿中显示出有希望的结果 和上颚在齿状前阶段募集以预防 ECC。 SAG 的可行性和成功导致 ECC预防率高达94%。因此，我们建议开发、验证和测试一种使用 移动应用程序向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期指导 (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（零腔），该应用程序基于费舍尔·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 与相关利益攸关方群体进行讨论，探讨对口腔健康的认识、实践和看法 父母、儿科医生和牙医的意见，并根据婴儿的年龄和具体状态制定量身定制的指导 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 零腔应用程序原型。在目标 2 中，我们将试点测试该应用程序的 Android 和 iOS 版本并评估 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 个母子二人组，并使用意图 治疗分析以确定通过零腔交付的移动应用程序辅助 SAG 方案的效果 应用程序。干预组和对照组都将在初次访视和每 6 个月亲自接受一次基线 AG 回忆道。此外，干预组将通过零腔应用程序在面对面的治疗之间接收 SAG。 访问。该试验将在印度临床试验注册中心（CTRI）注册后进行，并遵守 CONSORT指南。 R33 阶段将以零腔应用程序的有效性评估结束 将 SAG 传递给母亲/父亲，从而预防 ECC。次要结果（ECC 的发生） 将使用国际龋齿检测和评估系统（ICDAS）进行测量，并通过校准 每隔 6 个月进行一次审查。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）向家长提供 SAG，从而实现可扩展的、具有成本效益的干预措施，预防 中低收入国家的 ECC。