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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNational Taiwan University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

The study population consists of adults aged 18 years and older with type 2 diabetes mellitus and diabetic kidney disease (CKD stages 1-5, not receiving dialysis). Participants will be recruited by convenience sampling from the outpatient clinic of the Department of Metabolism and Endocrinology at National Taiwan University Hospital.

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

161 Participants
are grouped into 1 trial group
Group A: Patients with Diabetic Kidney Disease,Type2 diabetes

Trial outcomes

Primary outcomes

1

Disease self-management

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.

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.
2

Psychological well-being

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.

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.
3

Social support

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.

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

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