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NCT Number: NCT07726589

The Relationship Between Psychological Well-being, Social Support, and Disease Self-management in Patients With Diabetic Nephropathy

This study will look at the psychological well-being and social support of people with diabetic kidney disease and how these factors are related to how well they manage their condition. Participants will complete questionnaires about their emotional well-being, the support they receive from others, and how they care for their disease. The results may help healthcare professionals better understand patients' needs and develop ways to improve disease self-management and overall health. The findings may also provide useful information for future research on diabetic kidney disease.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, Zhongzheng District, 100, Taiwan

Location contact

Kaichi Chen

PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital National Taiwan University Hospital

CONTACT

[email protected]

+886-2312-3456 Extension: 8857

About this study

This study investigates the current status of psychological well-being and social support among patients with diabetic kidney disease and examines their associations with disease self-management. It is anticipated that the findings will increase healthcare professionals' awareness of the importance of assessing patients' psychological well-being and social support, thereby facilitating improvements in disease self-management. Furthermore, the findings are expected to provide empirical evidence and serve as a reference for future studies related to diabetic kidney disease, psychological well-being, social support, and disease self-management.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 years or older.
  • Diagnosed with type 2 diabetes mellitus and diabetic kidney disease.
  • Chronic kidney disease (CKD) stages 1-5, classified by estimated glomerular filtration rate (eGFR), without receiving dialysis.
  • Mentally competent and without diagnosed psychiatric disorders.
  • Able to communicate in Mandarin or Taiwanese and understand the questionnaire
  • Willing to participate in the study and provide written informed consent

Exclusion criteria

  • Diagnosed with type 1 diabetes mellitus.
  • End-stage kidney disease requiring dialysis.
  • Severe cognitive impairment or inability to complete the questionnaire independently.
  • History of major psychiatric disorders documented in the medical records.

Treatment and study plan

Primary outcomes

  1. Disease self-management

    Time frame: As this is a cross-sectional study, all outcome measures, including psychological well-being, social support, and disease self-management, will be assessed once at baseline at the time of study enrollment.

    Disease self-management assessed using the Diabetic Nephropathy Self-Management Scale (DN-SM).The 29-item instrument evaluates self-management behaviors across four domains: self-integration, problem solving, seeking social support, and adherence to the recommended regimen. Each item is rated on a 4-point Likert scale (1 = never, 2 = sometimes, 3 = often, 4 = always). Higher total scores indicate better disease self-management ability.

  2. Psychological well-being

    Time frame: As this is a cross-sectional study, all outcome measures, including psychological well-being, social support, and disease self-management, will be assessed once at baseline at the time of study enrollment.

    Psychological well-being will be assessed using the World Health Organization-Five Well-Being Index (WHO-5), a self-administered instrument developed by the World Health Organization. The WHO-5 evaluates psychological well-being during the previous 14 days and consists of five items rated on a 6-point Likert scale from 0 ("at no time") to 5 ("all of the time"). Total scores range from 0 to 25, with higher scores indicating better psychological well-being.

  3. Social support

    Time frame: As this is a cross-sectional study, all outcome measures, including psychological well-being, social support, and disease self-management, will be assessed once at baseline at the time of study enrollment.

    Social support will be assessed using the Interpersonal Support Evaluation List, ISEL-SF16. The instrument evaluates four domains: appraisal support, tangible support, self-esteem support, and belonging support. Each item is rated on a 4-point Likert scale ranging from 0 ("strongly disagree") to 3 ("strongly agree"). Total scores range from 0 to 48, with higher scores indicating greater perceived social support.

Study contacts

Contact information is provided by the study sponsor or research team.

Kaichi Chen

CONTACT

[email protected]

+886 939-320-763

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 24, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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