Development and Testing of a Mobile Health Application for Management of Gestational Diabetes

用于管理妊娠糖尿病的移动健康应用程序的开发和测试

• 批准号: 10246652
• 负责人: Shristi Rawal
• 金额: $ 10.64万
• 依托单位: RBHS-SCHOOL/ HEALTH RELATED PROFESSIONS
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-06 至 2022-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10246652
• 关键词: Adherence; Behavior; Blood Glucose; Carbohydrates; Caring; Cellular Phone; Cesarean section; Child; China; Clinical; Collaborations; Community Health; Counseling; Country; Data; Development; Diabetes Mellitus; Diet; Diet Modification; Educational workshop; Electronic Mail; Epidemic; Family member; Feedback; Focus Groups; Fostering; Future; Geography; Gestational Diabetes; Glucose; Goals; Government; Gynecologist; Health; Health Technology; Health education; Healthcare; Hospitals; Income; India; Induced Labor; Industry; Intake; International; Intervention; Interview; Knowledge; Life; Life Style; Life Style Modification; Measures; Mobile Health Application; Monitor; Mothers; Neonatal; Nepal; Newly Diagnosed; Non-Insulin-Dependent Diabetes Mellitus; Outcome; Paper; Patients; Pattern; Penetration; Phase; Physical activity; Population; Postpartum Period; Pregnancy; Prevalence; Process; Protocols documentation; Public Health Informatics; Randomized; Regimen; Reporting; Research; Research Activity; Research Project Grants; Resources; Risk; Self Efficacy; Self Management; Services; Testing; Text Messaging; Time; Training; Treatment outcome; Universities; University Hospitals; Visual; Woman; Work; antenatal care; base; behavior change; clinical decision-making; control trial; cost effectiveness; data visualization; design; diabetes self-management; diabetic; digital; efficacy testing; family support; glycemic control; health goals; implementation science; improved; informant; innovation; intergenerational; lifestyle intervention; low and middle-income countries; mHealth; mobile application; mobile computing; offspring; organizational structure; patient oriented; physical therapist; prevent; prototype; public health relevance; recruit; scale up; skills; smartphone Application; social cognitive theory; standard care; suburb; usability; user centered design

Project Summary The prevalence of gestational diabetes mellitus (GDM) is rapidly increasing worldwide, particularly in low- and middle-income countries (LMICs). Tight glycemic control via diet and lifestyle modification is critical to treating GDM and preventing its adverse health consequences, including increased risk of type 2 diabetes (T2D), in women and their children. However, in many resource-limited countries including Nepal, time for diet/lifestyle counseling often competes with other components of antenatal care. Mobile health (mHealth) technology can be leveraged to promote healthy behaviors, and support self-management and treatment of GDM, but this approach has not been tried previously in any LMICs. Taking a user-centered design approach, here we propose to develop a culturally- appropriate smartphone application (app) to support self-management of GDM (mGDM), and test its usability and preliminary efficacy, among patients in a tertiary level, university hospital of Kathmandu University, Nepal. Based on the Social Cognitive Theory framework for behavior change, this app will assist in self-management of GDM by increasing the patient's knowledge and self-efficacy to adhere to the recommended diet and physical activity regimens. The app will also help clinicians by generating easily digestible visual displays of patient data and behaviors, which can aid in their clinical decision-making and counseling. In the requirements gathering phase, 6 GDM patients will be recruited into a focus group to view paper prototypes and provide feedback on its features and functions. Additional questions will be asked about their perceived barriers, facilitators, and strategies for lifestyle modification. Key informant interviews will also be conducted with 5 clinicians (gynecologists, dietician, physical therapist) and 3 family members, asking them to provide feedback on the mGDM prototype, especially pertaining to the usefulness and format of the graphic summaries of patient data. After revising paper prototypes and developing the first digital prototype, six additional patients with GDM will be recruited for two rounds of usability testing including think-aloud protocol and focus group discussions. Final prototype will be developed following an iterative process of product design and user testing. After developing the app, we will recruit 60 women who are newly diagnosed with GDM, and randomly assign them to one of two treatment conditions: either (A) mGDM app + standard care, or (B) standard care alone, from 28 weeks of gestation to delivery. In this proof-of-concept trial, feasibility outcomes will be app usage, self-monitoring adherence, and app usability and acceptability. Exploratory treatment outcomes will be glycemic control measures at 6 weeks postpartum, neonatal birthweight, and rates of labor induction and caesarean delivery. Findings from the proposed study will empirically inform a future randomized control trial that will be fully powered to test the efficacy and cost-effectiveness of the mGDM app in improving treatment outcomes, using an R01 mechanism. We expect that the research activities and capacity building initiatives proposed in this application will build the institutional skills and create the organizational structure needed to enable future mHealth research initiatives at Kathmandu University, even beyond the scope of this proposed project.

项目摘要 妊娠糖尿病（GDM）的患病率在全球范围内迅速增加，尤其是在低 - 和 中等收入国家（LMIC）。通过饮食和生活方式修改严格控制血糖控制对于治疗GDM至关重要 并防止其不良健康后果，包括增加2型糖尿病风险（T2D），女性和 他们的孩子。但是，在包括尼泊尔在内的许多资源有限的国家中，经常进行饮食/生活方式咨询时间 与产前护理的其他组成部分竞争。可以利用移动健康（MHealth）技术来促进 健康的行为，并支持GDM的自我管理和治疗，但是这种方法尚未尝试 以前在任何LMIC中。采用以用户为中心的设计方法，在这里我们建议在文化上发展一种 适当的智能手机应用程序（APP）支持GDM（MGDM）的自我管理，并测试其可用性和 初步疗效，在三级级别的患者中，尼泊尔加德满都大学医院。基于 社会认知理论的行为改变框架，该应用程序将有助于通过 提高患者的知识和自我效能感，以遵守建议的饮食和体育锻炼 方案。该应用程序还将通过生成易于消化的患者数据的视觉显示和 行为，可以帮助他们的临床决策和咨询。在需求聚会阶段，6 GDM患者将被招募到焦点小组中，以查看纸张原型，并就其功能和 功能。将询问有关其感知障碍，促进者和生活方式策略的其他问题 修改。主要的线人访谈还将与5位临床医生（妇科医生，营养师，身体 治疗师）和3名家庭成员，要求他们提供有关MGDM原型的反馈，特别是与 患者数据的图形摘要的有用性和格式。修改了纸张原型并开发 第一个数字原型，另外六名GDM患者将被招募，以进行两轮可用性测试 思考协议和焦点小组讨论。最终原型将在迭代过程中开发 产品设计和用户测试。在开发了该应用程序之后，我们将招募60名新诊断的女性 GDM，然后随机分配给两个治疗条件之一：（a）MGDM App +标准护理，或（b） 仅标准护理，从28周的妊娠到分娩。在此概念验证的试验中，可行性结果将是 应用使用，自我监控依从性以及应用程序可用性和可接受性。探索性治疗结果将是 产后6周的血糖控制措施，新生儿体重和劳动诱导率和剖腹产率 送货。拟议研究的发现将在经验上为未来的随机控制试验提供信息，这将是完全的 使用MGDM应用程序的功效和成本效益来改善治疗结果，并使用 R01机制。我们希望在本申请中提出的研究活动和能力建设计划 将建立机构技能，并创建实现未来MHealth研究所需的组织结构 加德满都大学的倡议，甚至超出了这个拟议项目的范围。