Diabetic Kidney Disease (DKD)NCT07726589
The Relationship Between Psychological Well-being, Social Support, and Disease Self-management in Patients With Diabetic Nephropathy
An observational study of Diabetic Kidney Disease (DKD) and Type 2 Diabetes, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Kidney Disease (DKD), Type 2 Diabetes
- How many people
- 161 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Aug 2026to 31 Dec 2028
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
National Taiwan University Hospital
Taipei, Zhongzheng District, 100
National Taiwan University Hospital National Taiwan University Hospital, +886-2312-3456 Extension: 8857, fctsai@ntu.edu.tw
Kaichi Chen
About this study
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.
Read the 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.
- Conditions
- Diabetic Kidney Disease (DKD), Type 2 Diabetes
- Keywords
- Diabetic kidney disease, Type 2 diabetes, Psychological Well-being, Social Support, Disease Self-management
- Medical subject headings
- Diabetic Nephropathies, Diabetes Mellitus, Type 2, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Diabetic Kidney Disease,Type2 diabetes | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start7 Aug 2026 (estimated)
- Primary completion7 Aug 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Diabetic Kidney Disease (DKD)Studies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 161 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726589
- Sponsor's protocol ID
- 202606008RINC
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 31640691United 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.
PubMed 34925864Mental 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.
PubMed 31876037Lin 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.
PubMed 22642723Kang E, Kim S, Rhee YE, Lee J, Yun YH. Self-management strategies and comorbidities in chronic disease patients: associations with quality of life and depression. Psychol Health Med. 2021 Sep;26(8):1031-1043. doi: 10.1080/13548506.2020.1838585. Epub 2020 Oct 23.
PubMed 33095059International Diabetes Federation. (2021). IDF diabetes Atlas reports. https//idf.org/ about-diabetes/diabetes-facts-figures
Chang HC, Chen SY, Chen CH. Predictors of Antenatal Psychosocial Stress in Taiwanese Women. J Nurs Res. 2016 Sep;24(3):193-200. doi: 10.1097/jnr.0000000000000122.
PubMed 26584041Bhasin AA, Molnar AO, McArthur E, Nash DM, Busse JW, Cooper R, Heale E, Ip J, Pang J, Blake PG, Garg AX, Kurdyak P, Kim SJ, Sultan H, Walsh M. Mental health and addiction service utilization among people living with chronic kidney disease. Nephrol Dial Transplant. 2024 Jun 28;39(7):1115-1124. doi: 10.1093/ndt/gfad240.
PubMed 38017620American Diabetes Association. (2025). How to slow the progression of chronic kidney disease. https://diabetes.org/about-diabetes/complications/chronic-kidney-disease/slow-progression-chronic-kidney-disease
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Psychological Well-being, Social Support, and Disease Self-management in Patients With Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT07726589
- Acronym / sponsor ID
- 202606008RINC
- Conditions
- Diabetic Kidney Disease (DKD), Type 2 Diabetes
- Keywords
- Diabetic kidney disease, Type 2 diabetes, Psychological Well-being, Social Support, Disease Self-management
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 161 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 7 Aug 2026 (estimated)
- Primary completion
- 7 Aug 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Diabetic Kidney Disease,Type2 diabetes | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- BackgroundWorld 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
- BackgroundWorld Health Orgnization. (2024). The top 10 causes of death. https://www.who.int/ news-room/fact-sheets/detail/the-top-10-causes-of-death
- Background: PubMed 31640691Wang 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.
- BackgroundUnited 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
- Background: PubMed 34925864Smekal 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.
- BackgroundMental Health Foundation. (2022). Physical health and mental health. https://www.mentalhealth.org.uk/explore-mental-health/a-z-topics/physical-health-and-mental-health
- Background: PubMed 31876037Lee 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.
- Background: PubMed 22642723Lin 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.
- Background: PubMed 33095059Kang E, Kim S, Rhee YE, Lee J, Yun YH. Self-management strategies and comorbidities in chronic disease patients: associations with quality of life and depression. Psychol Health Med. 2021 Sep;26(8):1031-1043. doi: 10.1080/13548506.2020.1838585. Epub 2020 Oct 23.
- BackgroundInternational Diabetes Federation. (2021). IDF diabetes Atlas reports. https//idf.org/ about-diabetes/diabetes-facts-figures
- Background: PubMed 26584041Chang HC, Chen SY, Chen CH. Predictors of Antenatal Psychosocial Stress in Taiwanese Women. J Nurs Res. 2016 Sep;24(3):193-200. doi: 10.1097/jnr.0000000000000122.
- Background: PubMed 38017620Bhasin AA, Molnar AO, McArthur E, Nash DM, Busse JW, Cooper R, Heale E, Ip J, Pang J, Blake PG, Garg AX, Kurdyak P, Kim SJ, Sultan H, Walsh M. Mental health and addiction service utilization among people living with chronic kidney disease. Nephrol Dial Transplant. 2024 Jun 28;39(7):1115-1124. doi: 10.1093/ndt/gfad240.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Kidney Disease (DKD) and Type 2 Diabetes, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaichi Chen (+886 939-320-763, kaichicheng@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07726589, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.