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Research to Investigate the Feasibility and Effectiveness of a Support Program for Patients With Early-Stage Kidney Disease

Exploratory Evaluation of the Feasibility and Effectiveness of a Patient Support Program Aimed at Improving Illness Recognition and Self-Care Behaviors in Patients With Early-Stage Diabetic Nephropathy:A Pilot Randomized Controlled Trial - Nephropathy Early-Stage Awareness and Self-care-Pilot: NESA-P

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000058743
Enrollment
24
Registered
2025-08-08
Start date
2025-08-08
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetic nephropathy

Interventions

Intervention group: Distribution of pamphlets + implementation of support program (three remote group sessions every two weeks) (approximately one month) Control group: Distribution of pamphlets + usu

Sponsors

Iwate Prefectural University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients who have been informed by their attending physician that they have nephropathy(including those informed at the time of the request for participation in this study) 2)Individuals capable of making independent decisions regarding treatment 3)Individuals capable of independently accessing the remote program 4)Individuals in middle age(30-64 years old) 5)Individuals who have provided written content to participate in this study

Exclusion criteria

Exclusion criteria: 1) Individuals who are unable to make independent decisions regarding treatment due to cognitive impairment or other reasons 2) Individuals who have difficulty accessing remote programs 3) Individuals who have not been informed by their attending physician about their kidney disease 4) Individuals currently receiving diabetes dialysis prevention guidance and management fees and undergoing medical care guidance 5) Individuals who have reached end-stage renal failure and have undergone artificial dialysis or kidney transplantation 6) Individuals currently receiving active treatment for conditions other than diabetes, such as malignant diseases

Design outcomes

Primary

MeasureTime frame
completion rate of research participation (One month after intervention)

Secondary

MeasureTime frame
Feasibility indicators Practicality of eligibility criteria, recruitment rate, consent rate Follow-up rate, understanding of reasons for dropout Acceptability of support programs Satisfaction, appropriateness of the program, ease of participation, barriers to participation Evaluation of educational materials (readability, clarity, volume) Difficulty in using Zoom Other evaluation items (exploratory indicators of intervention effectiveness): -CKD self-care ability (Japanese version of the CKD Self-Care Scale) -Disease perception (Brief Illness Perception Questionnaire (B-IPQ) (Broadbent, Petrie, Main, & Weinman, 2006) Japanese version) (Hashimoto, 2013) -Self-Efficacy (Chronic Disease Self-Efficacy Scale for Health Behaviors) (Kim et al., 1996) -PAID Japanese Version (Hayashino et al., 2024) -QOL (WHO-QOL26)

Countries

Japan

Contacts

Public ContactYuka Fujisawa

Iwate Prefectural University Faculty of Nursing

f_yuka@iwate-pu.ac.jp0196942222

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026