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

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

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.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

169

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Wugu District
      • New Taipei City, Wugu District, Taiwan, 248524
        • Wugu District Public Health Center,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The experimental group receives usual care and 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.
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.)
Other: The control group that receives usual care and the local integrated medical network information
receives usual care and the local integrated medical network information, including clinics and healthcare institutes that provide comorbidity care and counseling.
receives usual care and the local integrated medical network information, including clinics and healthcare institutes that provide comorbidity care and counseling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

December 16, 2025

First Submitted That Met QC Criteria

December 16, 2025

First Posted (Actual)

December 30, 2025

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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