- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07310849
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
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Wugu District
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New Taipei City, Wugu District, Taiwan, 248524
- Wugu District Public Health Center,
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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.)
|
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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.
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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
Publications and helpful links
General Publications
- 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.
- 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.
- Chiu CJ,Li ML,Chang CM,Wu CH,Tan MP
- Bing Y,Yuan L,Liu J,Wang Z,Chen L,Sun J,Liu L
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Crystal Arthropathies
- Endocrine System Diseases
- Musculoskeletal Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Arthritis
- Joint Diseases
- Rheumatic Diseases
- Purine-Pyrimidine Metabolism, Inborn Errors
- Metabolism, Inborn Errors
- Genetic Diseases, Inborn
- Metabolic Diseases
- Glucose Metabolism Disorders
- Lipid Metabolism Disorders
- Gout
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Nutritional and Metabolic Diseases
- Hypertension
- Diabetes Mellitus
- Dyslipidemias
- Arthritis, Gouty
Other Study ID Numbers
- IRB 24 021 B1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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