跳至主要内容
临床试验/NCT07310849
NCT07310849招募中不适用

Digital Care Community Common Good Program Enhances Holistic Health Management for Middle Aged and Older Adults With Diabetes Mellitus and Multiple Chronic Conditions

Chang Gung University of Science and Technology3 个研究点 分布在 1 个国家目标入组 169 人开始时间: 2026年5月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
169
试验地点
3
主要终点
The Disease Self-Management Scale

研究概览

简要总结

The purpose of this study was to explore the effectiveness of the "Digital Care Community Common Good" program in improving disease control indicators, self-management abilities, depression, and quality of life among patients with comorbidities and type 2 diabetes. The study was designed as a two-year experimental study, with a specific area in New Taipei City selected as the research site. In the first year, the main tasks include establishing an integrated intervention team composed of primary healthcare providers and community resources, expanding the functionalities of the mHealth platform, developing digital educational materials for diabetes comorbidities care, and recruiting and training 6 to 8 community care volunteers. Additionally, 169 eligible participants with type 2 diabetes and comorbidities will be recruited from four communities, completing baseline assessments and randomization into groups. In the second year, a 6-month intervention and effectiveness evaluation of the " Digital Care Community Common Good " program will be implemented. The intervention includes online and in-person educational sessions, telephone care, use of the mHealth platform (featuring educational, data monitoring, contextual learning, interactive, and reminders), as well as home visits, case discussions, and individualized care plans for high-risk cases. Disease control indicators, selfmanagement abilities, depression, and quality of life will be tracked immediately post-intervention, at 3 month, and at 6 month to assess outcomes and changes over time. This study expects to enhance health management for diabetes patients with comorbidities through digital care and interdisciplinary collaboration, offering evidence-based insights and recommendations for policy implementation in the integration of community and primary healthcare models.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Age and Consent: Individuals aged 50 years or older who are willing to provide written informed consent.
  • Language and Literacy: Participants must be literate and able to communicate in Mandarin or Taiwanese.
  • Medical Diagnosis: Participants must have a physician-confirmed diagnosis of type 2 diabetes mellitus (T2DM) and at least one comorbid chronic disease (e.g., hypertension, hyperlipidemia, chronic kidney disease, or heart disease).
  • Technology Use: Participants must own a smartphone and be willing to use the LINE messaging app and web-based health education links.
  • Residence: Participants must reside within one of the four participating communities and have no plans to move away during the study intervention period.

排除标准

  • Those with severe diabetes-related complications, such as renal failure, cerebrovascular disease, diabetic foot, or retinopathy.
  • Individuals with psychiatric disorders, undergoing active cancer treatment, or those unable to perform independent self-care (e.g., due to visual impairment or mobility limitations).
  • Individuals without diabetes but with other chronic diseases.
  • Individuals residing in long-term care institutions.
  • Individuals who are simultaneously participating in other intervention programs.

研究组 & 干预措施

The experimental group receives usual care and a 6-month Digital Care Community Common Good program

Experimental

online and in-person educational sessions, telephone care, use of the mHealth platform (featuring educational, data monitoring, contextual learning, interactive, and reminders), as well as home visits, case discussions, and individualized care plans for high-risk cases.

干预措施: Digital Care Community Common Good Program (Behavioral)

The control group that receives usual care and the local integrated medical network information

Other

receives usual care and the local integrated medical network information, including clinics and healthcare institutes that provide comorbidity care and counseling.

干预措施: Usual Care (Behavioral)

结局指标

主要结局

The Disease Self-Management Scale

时间窗: T0 Pre-Test: Conducted before the intervention. T1: Conducted immediately after completing the intervention. T2: Conducted three months after completing the intervention. T3: Conducted six months after completing the intervention.

This study employs the Disease Self-Management Scale by Professor Ching-Min Chen (2012), based on the Chronic Disease Care Management Model. The scale includes 39 items across four subscales: Partnership, Self-care performance, Problem-solving, and Emotional management. Each item is rated on a 4-point Likert scale (0-3), reflecting participants' self-management behaviors over the past three months. Higher scores indicate better self-management ability. The scale has been validated in community-based studies involving older adults with multiple metabolic chronic diseases, demonstrating strong reliability and validity. Cronbach's alpha (total scale): .83. Subscales: Partnership (.88), Self-care activities (.78), Problem-solving (.90), Emotional management (.60). Internal consistency is considered satisfactory.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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