Development of Multi-Platform Mobile App Technology for Real-Time Measurement of Menstrual Cycle Characteristics in Adolescents

开发实时测量青少年月经周期特征的多平台移动应用程序技术

• 批准号: 9978426
• 负责人: SARAH H. OBRIEN
• 金额: $ 27.04万
• 依托单位: RESEARCH INST NATIONWIDE CHILDREN'S HOSP
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-01 至 2022-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9978426
• 关键词: 14 year old; 17 year old; Acceleration; Adolescent; Age; Android; Blood; Blood flow; Body Weight; Body mass index; Cellular Phone; Characteristics; Client satisfaction; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Collection; Contraceptive methods; Crossover Design; Data; Development; Diagnosis; Dysmenorrhea; Early Diagnosis; Early Intervention; Exploratory/Developmental Grant for Diagnostic Cancer Imaging; Female; Female Adolescents; Frequencies; Goals; Health; Health Insurance Portability and Accountability Act; Hemorrhage; Intervention Trial; Irregular Menstruation; Laboratories; Language; Link; Location; Longitudinal Studies; Measurement; Measures; Medical; Menarche; Menstrual cycle; Menstruation; Monitor; National Institute of Child Health and Human Development; Normal Range; Obesity; Obesity Epidemic; Outcome; Pain; Paper; Participant; Patient Outcomes Assessments; Patient Transfer; Patients; Pattern; Periodicity; Population; Positioning Attribute; Prospective cohort study; Publishing; Quality of life; Race; Randomized; Reporting; Research; Research Personnel; Severities; Technology; Testing; Time; Treatment/Psychosocial Effects; United States; Uterine hemorrhage; Weight; Work; base; data exchange; design; experience; improved; innovation; mobile application; mobile computing; patient engagement; patient population; preference; primary outcome; psychosocial; racial diversity; recruit; reproductive morbidity; research study; satisfaction; smartphone Application; temporal measurement; tool; tv watching; usability; young woman

PROJECT SUMMARY / ABSTRACT Abnormal uterine bleeding occurs in over 25% of adolescents. Establishing normative data for menstrual bleeding would facilitate earlier diagnosis of abnormal bleeding and earlier interventions to improve health and quality of life. Current data on duration and timing from menarche to the establishment of normal menstrual cyclicity are sparse, and despite the known impact of race and obesity on timing of menarche, normative data by race and body mass index are even more limited. Advancements such as smart phones enable greater access to adolescents and decrease barriers to research on menstruation. Successful technology in this arena requires a multi-platform application (app) that allows for transfer of HIPAA-compliant patient-level information directly to researchers and demonstrates sustained patient engagement. The objective of this R21 application is to expand upon our prior work by developing a multi-platform application, and testing compliance and engagement with the app in younger adolescents with diversity in race and body weight. The rationale for this research is that development of patient-directed electronic menstrual tracking technology with immediate and seamless transition of data to researchers will enable the design of multiple longitudinal studies of menstrual bleeding patterns. The proposed work is responsive to the NICHD's call for the “development of innovative tools and technologies to measure menstrual cycle characteristics such as bleeding, pain, and menstrual irregularity.” The specific aims of this application are: 1) develop a multi-platform menstrual tracking app to measure the degree and duration of bleeding, irregularity, location and severity of pain (dysmenorrhea), and the psychosocial impact of menses; and 2) test patient satisfaction, compliance, and sustained engagement with the app in a six-month prospective cohort study of 10-14 year-old females, and evaluate the impact of patient age, race and body mass index on these outcomes. The proposed work is innovative because our technology allows for the transfer of patient-level menstrual data to investigators on a variety of domains and our patient population includes young adolescents of diverse race and body weight. Completion of this R21 award will yield the following expected outcomes: 1) a multi-platform menstrual tracking app with high patient usability and satisfaction ratings, and 2) demonstration of the feasibility and initial sustainability of mobile electronic menstrual tracking in adolescents. These outcomes will lead to submission of an R01 application to utilize the technology herein created to perform a longitudinal assessment of race and weight-based norms of menstrual bleeding patterns during pubertal progression. The proposed work is significant because it will yield a new application of technology that can be used in multiple future research studies by our research team and others to both establish normal ranges of menstrual cycle characteristics across the age spectrum and across populations, and measure patient-reported outcomes in clinical trials of interventions for abnormal uterine bleeding.

项目摘要 /摘要 异常的子宫出血发生在超过25％的青少年中。建立月经的正常数据 出血将有助于早期诊断异常出血和早期干预措施，以改善健康和 生活质量。当前关于从初任到建立正常月经的持续时间和时间的数据 循环性很少，使命是种族和肥胖对初潮时间的已知影响，正常数据 根据种族和体重指数，甚至更加有限。诸如智能手机之类的进步可以使更多访问 给青少年，减少月经研究的障碍。在这个领域的成功技术需要 一个多平台应用程序（APP），允许将符合HIPAA的患者级信息转移到 研究人员并证明了持续的患者参与度。该R21应用程序的目的是扩展 在我们先前的工作中，通过开发多平台应用程序，测试合规性和与 在种族和体重多样性的年轻青少年中应用。这项研究的理由是 开发具有直接和无缝的患者指导的电子月经跟踪技术 将数据向研究人员的过渡将使月经出血的多个纵向研究设计 模式。拟议的工作对NICHD呼吁“开发创新工具和 测量月经周期特征的技术，例如出血，疼痛和月经不规则。” 该应用程序的具体目的是：1）开发一个多平台的月经跟踪应用程序来衡量学位 疼痛的出血，不规则，位置和严重程度（痛经）和心理社会影响的持续时间 月经； 2）在六个月内测试患者满意度，合规性和持续与该应用程序的参与度 10-14岁女性的前瞻性队列研究，并评估患者年龄，种族和体重的影响 这些结果的索引。拟议的工作具有创新性，因为我们的技术允许转移 患者级的月经数据向调查人员提供了各种领域，我们的患者人数包括年轻 潜水员种族和体重的青少年。该R21奖项的完成将产生以下预期 结果：1）具有高患者可用性和满意度等级的多平台月经跟踪应用程序，2） 展示了青少年移动电子月经跟踪的可行性和最初可持续性。 这些结果将导致提交R01应用程序，以利用此处创建的技术来执行 对青春期期间月经出血模式的种族和基于体重的纵向评估 进展。拟议的工作很重要，因为它将产生新的技术应用 我们的研究团队和其他人都在多项研究中使用，以建立正常范围 整个年龄频谱和人群之间的月经周期特征，并测量患者报告 异常子宫出血干预措施的临床试验结果。