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.

项目概要 妊娠期糖尿病 (GDM) 的患病率在全球范围内迅速增加，特别是在低收入和低收入人群中 中等收入国家（LMIC）。通过饮食和生活方式调整严格控制血糖对于治疗 GDM 至关重要 并预防其对健康造成的不良后果，包括增加女性和女性患 2 型糖尿病 (T2D) 的风险 他们的孩子。然而，在包括尼泊尔在内的许多资源有限的国家，饮食/生活方式咨询的时间往往很短。 与产前护理的其他组成部分存在竞争。可以利用移动医疗（mHealth）技术来促进 健康行为，支持GDM的自我管理和治疗，但这种方法尚未尝试过 之前曾在任何中低收入国家工作过。采用以用户为中心的设计方法，在这里我们建议开发一种文化- 适当的智能手机应用程序（app）来支持GDM（mGDM）的自我管理，并测试其可用性和 尼泊尔加德满都大学医院三级患者的初步疗效。基于 行为改变的社会认知理论框架，该应用程序将通过以下方式协助 GDM 的自我管理 增加患者的知识和自我效能，以坚持推荐的饮食和身体活动 治疗方案。该应用程序还将通过生成易于理解的患者数据和视觉显示来帮助临床医生 行为，这可以帮助他们进行临床决策和咨询。在需求收集阶段，6 GDM 患者将被招募到焦点小组中，以查看纸质原型并提供有关其功能和功能的反馈。 功能。将询问有关他们感知到的障碍、促进因素和生活方式策略的其他问题 修改。还将对 5 名临床医生（妇科医生、营养师、物理医生）进行关键信息访谈。 治疗师）和 3 位家庭成员，要求他们提供有关 mGDM 原型的反馈，特别是与 患者数据图形摘要的有用性和格式。修改纸质原型并开发后 第一个数字原型将招募另外六名 GDM 患者进行两轮可用性测试，包括 出声思考协议和焦点小组讨论。最终原型将按照以下迭代过程开发 产品设计和用户测试。开发完该应用程序后，我们将招募 60 名新诊断患有此病的女性 GDM，并将他们随机分配到两种治疗条件之一：(A) mGDM 应用程序 + 标准护理，或 (B) 仅标准护理，从妊娠 28 周到分娩。在这个概念验证试验中，可行性结果将是 应用程序使用情况、自我监控遵守情况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、新生儿出生体重、引产率和剖腹产率 送货。拟议研究的结果将为未来的随机对照试验提供经验信息，该试验将充分 能够测试 mGDM 应用程序在改善治疗结果方面的功效和成本效益，使用 R01机制。我们期望本申请中提出的研究活动和能力建设举措 将培养未来移动医疗研究所需的机构技能和组织结构 加德满都大学的倡议，甚至超出了本拟议项目的范围。