A Cross-Sectional Observational Study to Evaluate Psychological Well-Being, Depression, and Health-Related Quality of Life and Their Demographic and Clinical Correlates in Adults With Type 2 Diabetes Attending an Outpatient Metabolic Clinic
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Shalom Scale Total Score (Psychological Well-Being)
Study Overview
Brief Summary
This prospective cross-sectional observational study aims to explore the relationships among psychological well-being, depression, and quality of life in patients with type 2 diabetes attending the outpatient metabolic clinic at National Taiwan University Hospital. The study will collect data using standardized instruments, including the EQ-5D Health-Related Quality of Life Questionnaire, the PHQ-9 Depression Scale, and the Shalom Scale of Psychological Well-Being, along with demographic and clinical variables such as age, sex, education, body mass index, HbA1c, disease duration, and psychosocial support indicators. Descriptive statistics, Pearson correlation analyses, ANOVA, and multiple linear regression modeling will be performed to identify factors associated with psychological well-being. The findings are expected to provide evidence-based insights to inform tailored interventions and improve the mental health and quality of life of patients with type 2 diabetes.
Detailed Description
This is a prospective, cross-sectional observational study designed to examine the relationships among psychological well-being, depression, and quality of life in adult patients with type 2 diabetes attending the outpatient metabolic clinic at National Taiwan University Hospital. The study seeks to identify demographic, clinical, and psychosocial factors associated with psychological well-being in this population.
Eligible participants will be ≥18 years old, diagnosed with type 2 diabetes, able to complete self-administered Chinese questionnaires, and willing to provide written informed consent. Patients with major psychiatric disorders, moderate to severe cognitive impairment, acute diabetic complications, or significant communication barriers will be excluded.
Data collection will include demographic variables (e.g., age, sex, education, marital status, religious belief, economic status, family support, sleep quality, exercise habits) and clinical indicators (e.g., diabetes duration, BMI, HbA1c, diabetic complications, estimated glomerular filtration rate). Three standardized instruments will be administered:
EQ-5D-5L to measure health-related quality of life
PHQ-9 to assess depressive symptoms
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults aged 18 years or older with full legal capacity.
- •Clinically diagnosed with Type 2 Diabetes Mellitus and receiving ongoing outpatient care.
- •Able to read and understand Chinese questionnaires and complete self-administered forms.
- •Understand the study purpose and procedures and provide written informed consent.
Exclusion Criteria
- •Presence of major psychiatric disorders (e.g., schizophrenia, bipolar disorder, major depressive disorder).
- •Moderate to severe cognitive impairment or dementia, as assessed by the clinical physician, making it impossible to complete the questionnaires.
- •Currently experiencing acute diabetic complications (e.g., diabetic ketoacidosis, hyperosmolar hyperglycemic state) or hospitalization.
- •Severe language or other communication barriers preventing expression of consent or understanding of study content.
Outcomes
Primary Outcomes
Shalom Scale Total Score (Psychological Well-Being)
Time Frame: At enrollment (single outpatient visit; questionnaires completed in approximately 30-40 minutes).
The Shalom Scale for Psychological Well-Being will be used to measure psychological well-being. Higher scores indicate better spiritual/psychological well-being. The total score will be analyzed as a continuous variable.
Secondary Outcomes
- PHQ-9 Total Score (Depression Severity)(Day 1)
- EQ-5D-5L Index Score (Health Utility)(Day 1)
- EQ-5D-5L Visual Analog Scale (VAS)(Day 1)