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Enrolling by Invitation

NCT Number: NCT07310849

Digital Care for Holistic Health in Older Adults With Diabetes and Multimorbidity

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.

Enrolling by Invitation

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Digital Care Community Common Good Program

Behavioral

a 6-month Digital Care Community Common Good program (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.)

Usual Care

Behavioral

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

Primary outcomes

  1. The Disease Self-Management Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chang Gung University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Dec 30, 2025
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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