UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058350 |
|---|---|
| Receipt number | R000066704 |
| Scientific Title | Comparison of Outcome Between Nursing Care Using NANDA-I, NOC, and NIC Frameworks and Routine Nursing Care for Elderly Aged 65 and Over with Frailty Syndrome |
| Date of disclosure of the study information | 2025/07/03 |
| Last modified on | 2025/07/02 20:01:08 |
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Basic information
Public title
A study on frailty care using NNN-based nursing plans in home visiting nursing
Acronym
NNN-Frailty Study
Scientific Title
Comparison of Outcome Between Nursing Care Using NANDA-I, NOC, and NIC Frameworks and Routine Nursing Care for Elderly Aged 65 and Over with Frailty Syndrome
Scientific Title:Acronym
NNN-Frailty Quasi-Exp
Region
| Japan |
Condition
Condition
Frailty syndrome in older adults
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effectiveness of nursing care using NANDA-I, NOC, and NIC (NNN) for care-dependent older adults diagnosed with frailty syndrome, by comparing it with usual nursing care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in outcome indicators based on the Nursing Outcomes Classification (NOC)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Visiting nurses provide nursing care based on standardized nursing languages including NANDA-I, NIC, and NOC, and evaluate nursing outcomes after 12 weeks.
Interventions/Control_2
Home-visiting nurses provide usual care based on conventional nursing processes without standardized language. Evaluation is performed at 12 weeks.
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
| 65 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals diagnosed with frailty syndrome in older adults.
Individuals confirmed to have a level of independence of IIb or lower in daily life for elderly people with dementia, based on information provided by their care manager.
Individuals who have given informed consent to participate in the study.
Key exclusion criteria
Individuals diagnosed by a physician as having a prognosis of less than six months.
Individuals facing an urgent and apparent life-threatening condition.
Individuals requiring prioritized medical interventions due to high risk of physical injury or other serious conditions.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Kira |
Organization
Shonan Kamakura University of Medical Sciences, Graduate School
Division name
Graduate School of Nursing
Zip code
247-0066
Address
1195-3 Yamazaki, Kamakura-shi, Kanagawa, Japan
TEL
0467-38-3131
soumu@sku.ac.jp
Public contact
Name of contact person
| 1st name | keiko |
| Middle name | |
| Last name | kira |
Organization
Shonan Kamakura University of Medical Sciences, Graduate School
Division name
Graduate School of Nursing
Zip code
247-0066
Address
1195-3 Yamazaki, Kamakura-shi, Kanagawa, Japan
TEL
0467-38-3131
Homepage URL
soumu@sku.ac.jp
Sponsor or person
Institute
Shonan Kamakura University of Medical Sciences, Graduate School
Institute
Department
Personal name
Funding Source
Organization
Shonan Kamakura University of Medical Sciences, Graduate School
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shonan Kamakura University of Medical Sciences, Graduate School
Address
1195-3 Yamazaki, Kamakura-shi, Kanagawa 247-0066, Japan
Tel
0467-38-3131
soumu@sku.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 | 07 | Month | 03 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | 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 | 07 | Month | 02 | Day |
Last modified on
| 2025 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066704
