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

Official title

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

Overview

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.

Interventions

• Behavioral Digital Care Community Common Good Program
  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.)
• Behavioral Usual Care
  receives usual care and the local integrated medical network information, including clinics and healthcare institutes that provide comorbidity care and counseling.

Primary outcome measures

• 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Health services research

Study locations

Taiwan · 1 center

• Wugu District Public Health Center, — New Taipei City

Publications

• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07310849 · IRB 24 021 B1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗