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临床试验/NCT06688903
NCT06688903招募中不适用

EMPOWERing Patients with Chronic Diseases Through Smartphone App, Health Coaching and Community-based Intervention

Singapore General Hospital2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年1月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
2
主要终点
HbA1c

研究概览

简要总结

Community-based health coaching interventions play a vital role in complementing the traditional chronic disease management model for type 2 diabetes patients. Compared to conventional approaches that often focus on periodic clinical visits, community-based coaching could provide continuous, personalised support within patients in everyday environments. Health coaches work directly with patients to set realistic goals, develop individualised action plans, and provide ongoing motivation and accountability. This personalised attention helps to improve self-management skills, such as medication adherence, dietary choices, and physical activity, which are crucial for chronic disease management and preventing complications. Our mobile health app, EMPOWER+ has multiple logging features, gamified elements to help users set goals and provide rewards, educational resources, and personalised nudges generated based on real users; inputs and predictive modeling. It has demonstrated some preliminary effectiveness and acceptability within the clinical settings. This trial aims to assess its effectiveness, adoption, and sustainability in the less-controlled community settings, preparing for its large implementation in the future.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 21 years and above
  • Having been diagnosed with type 2 diabetes mellitus
  • Having most recent HbA1c ≥ 6.5%
  • Physically able to exercise
  • Able to read, write, and converse in English
  • Able to comply with study procedures

排除标准

  • Requiring assistance with basic activities of daily living (BADL)
  • Have planned major operation or surgical procedure within 6 months from the time of recruitment
  • Current pregnant or lactating

结局指标

主要结局

HbA1c

时间窗: 6 months

HbA1c over 6 months

次要结局

  • Physical activity as measured by number of steps(6 months)
  • Physical activity as measured by moderate to vigorous active minutes(6 months)
  • Physical activity as measured by GPAQ(6 months)
  • Patient activation score as measured by patient activation measure(6 months)
  • Medication adherence as measured by MARS-5(6 months)
  • Quality of life as measured by EQ-5D-5L(6 months)
  • Healthcare cost as measured by cost of consultations, lab tests, medications, admission(6 months)
  • Healthcare cost as measured by WPAI(6 months)
  • Maintenance of the intervention effects on HbA1c(6 months)
  • Maintenance of the intervention effects on blood pressure(6 months)
  • Maintenance of the intervention effects on total cholesterol(6 months)
  • Maintenance of the intervention effects on high-density lipoprotein (HDL)(6 months)
  • Maintenance of the intervention effects on low-density lipoprotein (LDL)(6 months)
  • Maintenance of the intervention effects on triglycerides(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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