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Not yet recruiting NCT07726589

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

Observational Diabetic Kidney Disease (DKD) Type 2 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Diabetic Kidney Disease (DKD), Type 2 Diabetes. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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.

Primary outcome measures

  • 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.]
  • 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.]
  • 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Taiwan · 1 center
  • National Taiwan University Hospital — Taipei

Publications

  • World Health Organization. (2024). The World Health Organization-Five Well-Being Index (WHO-5). https://www.who.int/publications/m/item/WHO-UCN-MSD-MHE-2024.01
  • World Health Orgnization. (2024). The top 10 causes of death. https://www.who.int/ news-room/fact-sheets/detail/the-top-10-causes-of-death
  • Wang X, He L, Zhu K, Zhang S, Xin L, Xu W, Guan Y. An integrated model to evaluate the impact of social support on improving self-management of type 2 diabetes mellitus. BMC Med Inform Decis Mak. 2019 Oct 22;19(1):197. doi: 10.1186/s12911-019-0914-9. PMID 31640691
  • United States Renal Data System. (2024). 2024 Annual Data Report: CKD in the General Population. https://usrds-adr.niddk.nih.gov/2024/chronic-kidney-disease/1-ckd-in-the-general-population
  • Smekal MD, Donald M, Beanlands H, Straus S, Herrington G, Waldvogel B, Sparkes D, Delgado M, Bello A, Hemmelgarn BR. Development and Preliminary Psychometric Testing of an Adult Chronic Kidney Disease Self-Management (CKD-SM) Questionnaire. Can J Kidney Health Dis. 2021 Dec 12;8:20543581211063981. doi: 10.1177/20543581211063981. eCollection 2021. PMID 34925864
  • Mental Health Foundation. (2022). Physical health and mental health. https://www.mentalhealth.org.uk/explore-mental-health/a-z-topics/physical-health-and-mental-health
  • Lee LY, Tung HH, Tsay SL, Chen YC, Lee HH, Zeng YX. Predictors for self-management in older adults with type 2 diabetic nephropathy. J Clin Nurs. 2020 Mar;29(5-6):922-931. doi: 10.1111/jocn.15154. Epub 2020 Jan 10. PMID 31876037
  • Lin CC, Wu CC, Wu LM, Chen HM, Chang SC. Psychometric evaluation of a new instrument to measure disease self-management of the early stage chronic kidney disease patients. J Clin Nurs. 2013 Apr;22(7-8):1073-9. doi: 10.1111/j.1365-2702.2011.04048.x. Epub 2012 May 30. PMID 22642723

Identifiers

NCT: NCT07726589 · 202606008RINC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗