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.

项目摘要 幼儿时期龋齿（ECC），尽管可以预防是第二个最常见的童年慢性疾病。 最近，数字健康引起了政府的重大兴趣 移动通信和远程医疗为克服的新可能性开辟了新的可能性的国家（LMIC） 医疗保健的地理无法获得。我们在幼儿龋齿中心的初步工作 使用电话，短信和提供适合年龄的婴儿口腔护理辅助工具的研究（CECCRE） 共同称为持续的预期指导（SAG）已显示出唇裂的婴儿的有希望的结果 并在防止ECC的牙齿前阶段招募了口感。 SAG的可行性和成功已导致 ECC预防高达94％。因此，我们建议开发，验证和测试一种新的方法 移动应用程序为父母提供适合年龄的下垂。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 将开发和测试一个互动移动应用程序（零腔），以费舍尔·欧文（Fisher Owen）的儿童模型为基础 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 讨论以探讨与相关利益相关者群体对口腔健康的认识，实践以及对口腔健康的看法 父母，儿科医生和牙医，并为婴儿的年龄和特定状态开发了量身定制的指导 口头开发。我们将使用设计思维，5DE方法和Nielsen Norman指南来开发 零腔应用程序原型。在AIM 2中，我们将尝试测试应用程序的Android和iOS版本并评估 使用UMARS，CALO-RE量表的用户感知。 R33阶段将在成功之后进行 R21里程碑的完成。在AIM 3中，我们将建立540个母子二元组，并使用意图 - 治疗分析以确定通过零腔提供的移动应用程序辅助SAG协议的效果 应用程序。干预和对照组将在初次访问和面对面的6个月内获得基线AG 回忆。此外，干预组将通过面对面的零腔应用程序接收SAG 访问。该试验将在临床试验注册处注册后进行，并遵守 配偶指南。 R33阶段将随着零腔应用程序的有效性评估而达到顶峰 在向母亲/父亲传递下垂的过程中，从而防止ECC。次要结果（ECC的出现） 将通过校准使用国际龋齿检测和评估系统（ICDA）来测量 审查员以6个每月的间隔。这项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）向父母提供SAG，导致可扩展的成本效益，以防止 LMIC国家的ECC。