Self-management, Type 2 Diabetes Mellitus (T2DM)
Conditions
Keywords
Diabetes self-management, Diabetes Obstacles, Self-efficacy, Metabolic indicators
Brief summary
This study aims to evaluate the effectiveness of a self-developed diabetes self-management mobile application on disease self-management outcomes among individuals with type 2 diabetes.
Interventions
BEHAVIORALResearcher-Designed Diabetes Self-Management Application
Participants in the intervention group will receive routine diabetes care and use the enhanced diabetes self-management mobile application. In addition to the basic self-management recording functions, the intervention group will receive video-based health education and multidisciplinary team care through the application. The multidisciplinary team may include healthcare professionals such as physicians, nurses, dietitians, and pharmacists, who provide diabetes-related guidance to support daily self-management, self-efficacy, and metabolic control.
Sponsors
Fu Jen Catholic University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Intervention model description
This is a two-arm, parallel-group randomized controlled trial. Participants will be assigned to either the control group or the intervention group. Both groups will use a diabetes self-management mobile application. The intervention group will receive additional video-based health education and multidisciplinary team care through the application.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with type 2 diabetes for more than 6 months and Hemoglobin A1c (HbA1c) \> 7.5%. * Having diabetes self-management obstacles. * Aged 18 years or older. * Conscious and able to communicate. * Having a smartphone with internet access. * Willing to participate in the study and provide written informed consent.
Exclusion criteria
* Gestational diabetes mellitus. * Currently taking steroid medications. * Having a severe infection requiring hospitalization within the past 6 months. * Unable to perform self-care independently. * Having participated in or currently participating in an educational program of a similar nature.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes management self-efficacy | Baseline, 3 months, and 6 months. | 1. The Chinese version of the Diabetes Management Self-Efficacy Scale(C-DMSES) includes 20 items across four subscales: 1. Nutrition: 9 items 2. Physical activity and weight control: 4 items 3. Medication treatment: 3 items 4. Blood glucose and foot care: 4 items 2. Scores range from 0 to 10. 3. The scale has good reliability, with an overall Cronbach's α of .93. 4. Subscale Cronbach's α values range from .77 to .93. 5. The scale also has good test-retest reliability, with Pearson's r = .86, p \< .01. |
| Diabetes self-management obstacles | Baseline, 3 months, and 6 months. | Diabetes self-management obstacles will be measured using the Chinese Version of the Diabetes Obstacles Questionnaire-Short Form (CDOQ-S). Each item is rated on a 5-point Likert scale, ranging from 1 to 5. The items are negatively scored, and higher scores indicate greater obstacles in diabetes self-management. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | Baseline, 3 months, and 6 months | Glycated hemoglobin (HbA1c) will be measured using laboratory blood tests and reported as a percentage (%) |
| Fasting plasma glucose | Baseline, 3months, and 6months | Fasting plasma glucose will be measured using laboratory blood tests and reported in milligrams per deciliter (mg/dL). |
| Triglycerides | Baseline, 3months, and 6 months | Serum triglyceride levels will be measured using laboratory blood tests and reported in milligrams per deciliter (mg/dL). |
| Total cholesterol | Baseline, 3 months, and 6 months. | Serum total cholesterol levels will be measured using laboratory blood tests and reported in milligrams per deciliter (mg/dL). |
| LDL | Baseline, 3 months, and 6 months. | Serum low-density lipoprotein cholesterol will be measured using laboratory blood tests and reported in milligrams per deciliter (mg/dL). |
| HDL | Baseline, 3 months, and 6 months. | Serum high-density lipoprotein cholesterol will be measured using laboratory blood tests and reported in milligrams per deciliter (mg/dL). |
Outcome results
None listed