A Diet Tracking, Monitoring and Optimization mHealth Tool for Patients with Inborn Errors of Metabolism

针对先天性代谢缺陷患者的饮食跟踪、监测和优化移动健康工具

• 批准号: 9680543
• 负责人: DerShung Yang
• 金额: $ 22.49万
• 依托单位: BRIGHTOUTCOME INC.
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-21 至 2019-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9680543
• 关键词: Address; Adherence; Agreement; Amino Acids; Brain; Budgets; Calories; Caregivers; Categories; Cessation of life; Clinical; Clinical Trials; Collection; Coma; Communities; Complex; Data; Databases; Developmental Disabilities; Diet; Diet Modification; Diet Records; Dietary Proteins; Dietary intake; Dietitian; Disease; Eating; Enzymes; Evaluation; Feedback; Focus Groups; Food; General Population; Genetic; Genetic Diseases; Goals; Hereditary Disease; Inborn Errors of Metabolism; Individual; Intake; Intellectual functioning disability; Interview; Lead; Measures; Metabolic Diseases; Metabolic Pathway; Methods; Monitor; Nutrient; Nutrition Assessment; Organ; Patients; Pharmaceutical Preparations; Phase; Poison; Population; Production; Proteins; Protocols documentation; Recommendation; Reducing diet; Reporting; Research; Research Personnel; Seizures; Single-Gene Defect; Site; Students; System; Technology; Testing; Work; base; clinically significant; design; diaries; food surveillance; improved; improved outcome; mHealth; medical food; neurochemistry; novel; nutrition; patient portal; prototype; recruit; success; tool; urea cycle; usability; user centered design; validation studies

Inborn errors of metabolism (IEM) are a group of rare genetic (inherited) disorders that cause a block in a metabolic pathway leading to clinically significant consequences, causing developmental and intellectual disabilities, seizures, and, if untreated, coma and death. The majority of the IEM disorders are managed by manipulation and modification of diet alone to reduce toxic metabolites, or with a combination of dietary modification and medications. The complex dietary therapies used in IEM challenge routine dietary recommendations and render diet apps designed for the general public of little utility in these conditions. Also, no diet app is developed specifically for the IEM community and meets the rigor required for research, particularly the need to measure specific and multiple amino acid content in the diet to facilitate more study on impact on brain neurochemistry. Within the field of IEM, the use of three-day diet diaries is utilized to monitor food intake. These diaries are frequently inadequate in capturing what is actually being consumed due to recall errors and other factors. Novel methods of assessing dietary intake and making individualized dietary recommendations for people with IEM are required to reduce the diet tracking burden and to improve the adequacy of dietary recommendations. We propose to develop and validate MyRareDiet to address an unmet need in the IEM population to assist with dietary management designed to increase adherence and compliance that leads to improved outcomes, while facilitating the collection of dietary data from individuals with IEM for research purposes. MyRareDiet includes a Patient Portal, a Clinical Dietician Portal, and a Researcher Portal. The Patient Portal is to help IEM patients track and monitor their own diet so they can meet their strict diet targets and restrictions. The Clinical Dietician Portal is to help clinical dieticians manage diet modifications for individuals with IEM. The Researcher Portal is to facilitate the conduct of diet-based studies and the analysis of study results. The aims for Phase I are: 1) Collect stakeholder feedback from stakeholders, including IEM patients/caregivers, dietitians, and researchers via focus groups; 2) Develop the prototype MyRareDiet system using user-centered design and the latest mobile-enabled e-technologies; 3) Conduct prototype evaluation including usability and usefulness tests and validation study comparing patient/caregiver-recorded diets using MyRareDiet and those recorded by nutrition students interviewing patients/caregivers with another diet recording tool. Our success criteria are based on evaluations on system usability (>=77.8), perceived usefulness (>=4), and the agreement (> 90%) of diets recorded by patients/caregivers and those by nutrition students.

天生的新陈代谢错误（IEM）是一组罕见的遗传（遗传）疾病，在代谢途径中引起障碍，导致临床上的显着后果，从而导致发育和智力障碍，癫痫发作，如果未治疗，则昏迷和死亡。大多数IEM疾病都是通过单独操纵和修改饮食来管理的，以减少有毒代谢产物，或结合饮食改性和药物。 IEM中使用的复杂饮食疗法挑战常规饮食建议，并在这些条件下为Little Utility公众设计的饮食应用程序。同样，没有专门针对IEM社区开发的饮食应用程序，并满足了研究所需的严格性，尤其是饮食中的特定和多个氨基酸含量的需求，以促进对脑神经化学影响的更多研究。在IEM领域，使用三天的饮食日记用于监测食物摄入量。这些日记通常不足以捕获由于召回错误和其他因素而实际消耗的东西。需要评估饮食摄入量并为IEM患者提出个性化饮食建议的新颖方法，以减轻饮食追踪负担并提高饮食建议的充分性。我们建议开发和验证Myrarediet，以满足IEM人群中未满足的需求，以协助饮食管理，旨在提高依从性和合规性，从而改善结果，同时促进IEM为了研究目的而收集的IEM患者的饮食数据。 Myrarediet包括患者门户，临床营养师门户和研究人员门户。患者门户将帮助IEM患者追踪和监测自己的饮食，以便他们可以满足严格的饮食目标和限制。临床营养师门户网站是帮助临床营养师管理IEM患者的饮食修改。研究人员门户将促进基于饮食的研究的进行和研究结果分析。第一阶段的目的是：1）通过焦点小组收集利益相关者的利益相关者的反馈，包括IEM患者/护理人员，营养师和研究人员； 2）使用以用户为中心的设计和最新的移动电子技术来开发原型Myrarediet系统； 3）进行原型评估，包括使用Myrarediet和营养生记录的患者/护理人员使用另一种饮食记录工具来比较患者/护理人员记录的患者/护理人员记录的饮食的原型评估和验证研究。我们的成功标准是基于对系统可用性（> = 77.8）的评估，可感知的有用性（> = 4），以及患者/护理人员和营养生记录的饮食的一致性（> 90％）。