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

NCT07310849 | Enrolling By Invitation

• 1 other identifier: IRB 24 021 B1
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type2Diabetes; Hypertension; Dyslipidemia; CKD; Cardio Vascular Disease; Gout Arthritis

Keywords

community care; diabetes mellitus; multimorbidity; quality of life; self-management

Outcome Measures

Primary Outcomes (1)

• The Disease Self-Management Scale

  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.

Study Arms (2)

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.

Behavioral: Digital Care Community Common Good Program

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.

Behavioral: Usual Care

Interventions

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.)

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

Usual Care BEHAVIORAL

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

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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung University of Science and Technology: lead

Study Sites (1)

Wugu District Public Health Center,

New Taipei City, Wugu District, 248524, Taiwan

Location

Related Publications (4)

• Chiu CJ, Li ML, Chang CM, Wu CH, Tan MP. Disability trajectories prior to death for ten leading causes of death among middle-aged and older adults in Taiwan. BMC Geriatr. 2021 Jul 10;21(1):420. doi: 10.1186/s12877-021-02300-z.

  PMID: 34246236 BACKGROUND

• Bing Y, Yuan L, Liu J, Wang Z, Chen L, Sun J, Liu L. Cluster analysis for the overall health status of elderly, multimorbid patients with diabetes. Front Public Health. 2023 Apr 4;11:1031457. doi: 10.3389/fpubh.2023.1031457. eCollection 2023.

  PMID: 37081950 BACKGROUND

• Espeland MA, Gaussoin SA, Bahnson J, Vaughan EM, Knowler WC, Simpson FR, Hazuda HP, Johnson KC, Munshi MN, Coday M, Pi-Sunyer X. Impact of an 8-Year Intensive Lifestyle Intervention on an Index of Multimorbidity. J Am Geriatr Soc. 2020 Oct;68(10):2249-2256. doi: 10.1111/jgs.16672. Epub 2020 Jul 17.

  PMID: 33267558 BACKGROUND

• Davis J, Fischl AH, Beck J, Browning L, Carter A, Condon JE, Dennison M, Francis T, Hughes PJ, Jaime S, Lau KHK, McArthur T, McAvoy K, Magee M, Newby O, Ponder SW, Quraishi U, Rawlings K, Socke J, Stancil M, Uelmen S, Villalobos S. 2022 National Standards for Diabetes Self-Management Education and Support. Diabetes Care. 2022 Feb 1;45(2):484-494. doi: 10.2337/dc21-2396. No abstract available.

  PMID: 35050365 BACKGROUND

Related Links

• Available upon reasonable request from the Principal Investigator.

MeSH Terms

Conditions

Hypertension; Dyslipidemias; Arthritis, Gouty; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Gout; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Glucose Metabolism Disorders; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 30, 2025
• Study Start: March 1, 2026
• Primary Completion: June 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)