UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058743 |
|---|---|
| Receipt number | R000067166 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2025/08/08 |
| Last modified on | 2025/08/08 16:52:34 |
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Basic information
Public title
Research to Investigate the Feasibility and Effectiveness of a Support Program for Patients With Early-Stage Kidney Disease
Acronym
Pilot Study of a Self-Care Support Program for Patients With Early Diabetic Nephropathy
Scientific Title
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
Scientific Title:Acronym
Nephropathy Early-Stage Awareness and Self-care-Pilot: NESA-P
Region
| Japan |
Condition
Condition
diabetic nephropathy
Classification by specialty
| Endocrinology and Metabolism | Nephrology | Nursing |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to explore the feasibility and effectiveness of an online support program that promotes disease awareness and self-care behaviors in patients with early-stage diabetic nephropathy.
The main objectives are to explore (1) the feasibility of recruitment and consent, (2) program completion, (3) the acceptability of evaluation indicators, (4) program acceptability, and (5) the potential effects of the program on disease awareness, self-efficacy, and self-care abilities.
Basic objectives2
Others
Basic objectives -Others
completion rate of research participation
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
completion rate of research participation (One month after intervention)
Key secondary outcomes
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)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: Distribution of pamphlets + implementation of support program (three remote group sessions every two weeks) (approximately one month)
Interventions/Control_2
Control group: Distribution of pamphlets + usual care + implementation of a support program after the study period (a total of three remote group sessions) (approximately one month)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key 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
Key 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
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Fujisawa |
Organization
Iwate Prefectural University
Division name
Faculty of Nursing
Zip code
020-0693
Address
152-52 Sugo, Takizawa City, Iwate Prefecture
TEL
0196942222
f_yuka@iwate-pu.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Fujisawa |
Organization
Iwate Prefectural University
Division name
Faculty of Nursing
Zip code
020-0693
Address
152-52 Sugo, Takizawa City, Iwate Prefecture
TEL
0196942222
Homepage URL
f_yuka@iwate-pu.ac.jp
Sponsor or person
Institute
Iwate Prefectural University
Institute
Department
Personal name
Yuka Fujisawa
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Iwate Prefectural University Research Ethics Review Committee
Address
152-52 Sugo, Takizawa City, Iwate Prefecture
Tel
0196943330
k-sien@ml.iwate-pu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 08 | Day |
Last modified on
| 2025 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067166
