Type2DiabetesNCT07310849
Digital Care for Holistic Health in Older Adults With Diabetes and Multimorbidity
A study testing Digital Care Community Common Good Program in people with Type2Diabetes and Hypertension, run by Chang Gung University of Science and Technology at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Type2Diabetes, Hypertension, Dyslipidemia
- What is being tested?
- Digital Care Community Common Good Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 May 2026to 1 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Wugu District Public Health Center,
New Taipei City, Wugu District, 248524
CHIOU-FENG HU,, +886 2 2260 3181
cherryjoe.loveyou@gmail.com
About this study
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
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
- Being tested
- Digital Care Community Common Good Program, Usual Care
- Keywords
- community care, diabetes mellitus, multimorbidity, quality of life, self-management
- Medical subject headings
- Hypertension, Dyslipidemias, Arthritis, Gouty, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Care Community Common Good ProgramBehavioural
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 CareBehavioural
receives usual care and the local integrated medical network information, including clinics and healthcare institutes that provide comorbidity care and counseling.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start12 May 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type2DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 169 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310849
- Sponsor's protocol ID
- IRB 24 021 B1
- Status last verified
- Aug 2026
- First submitted
- 16 Dec 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34246236Bing 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.
PubMed 37081950Espeland 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.
PubMed 33267558Davis 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.
PubMed 35050365