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.

项目概要/摘要 超过 25% 的青少年出现异常子宫出血 建立月经规范数据。 出血将有助于异常出血的早期诊断和早期干预措施，以改善健康状况和 从初潮到正常月经的持续时间和时间的当前数据。 周期性很少，尽管已知种族和肥胖对初潮时间的影响，但规范数据 因种族和体重指数而异，智能手机等进步使得获取更多信息变得更加有限。 青少年并减少月经研究的障碍需要成功的技术。 多平台应用程序 (app)，允许将符合 HIPAA 的患者级别信息直接传输到 研究人员和持续展示的患者参与度是 R21 应用的目标。 基于我们之前的工作，开发了一个多平台应用程序，并测试了与 这项研究的基本原理是： 开发以患者为导向的电子月经追踪技术，可立即、无缝地进行 将数据转移给研究人员将有助于设计月经出血的多项纵向研究 拟议的工作响应了 NICHD“开发创新工具和技术”的号召。 测量月经周期特征（例如出血、疼痛和月经不规律）的技术。” 该应用程序的具体目标是：1）开发一个多平台月经跟踪应用程序来测量月经程度 出血的持续时间、不规则性、疼痛的部位和严重程度（痛经）以及社会心理影响 月经次数；2) 测试患者在六个月内的满意度、依从性和对应用程序的持续参与度 对10-14岁女性进行前瞻性队列研究，评估患者年龄、种族和体重的影响 拟议的工作具有创新性，因为我们的技术允许转移 向各个领域的研究人员提供患者级别的月经数据，我们的患者群体包括年轻人 不同种族和体重的青少年完成此 R21 奖项将产生以下预期成果。 结果：1) 具有高患者可用性和满意度的多平台月经跟踪应用程序，以及 2) 展示青少年移动电子月经追踪的可行性和初步可持续性。 这些结果将导致提交 R01 申请，以利用此处创建的技术来执行 对青春期月经出血模式的种族和体重标准进行纵向评估 拟议的工作意义重大，因为它将产生一种新的技术应用，可以 我们的研究团队和其他人在未来的多项研究中使用它来建立正常范围 跨年龄范围和跨人群的月经周期特征，并测量患者报告的 异常子宫出血干预措施的临床试验结果。