UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055871 |
|---|---|
| Receipt number | R000063849 |
| Scientific Title | The open-label, parallel-group feasibility study to assess the impact of community nursing on well-being, social and health. |
| Date of disclosure of the study information | 2024/11/01 |
| Last modified on | 2025/01/07 14:26:40 |
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Basic information
Public title
The open-label, parallel-group feasibility study to assess the impact of community nursing on well-being, social and health.
Acronym
Commune 1st
Scientific Title
The open-label, parallel-group feasibility study to assess the impact of community nursing on well-being, social and health.
Scientific Title:Acronym
Commune 1st
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess changes in the interdependent happiness of community residents who have received community nursing*1.
In addition, a group comparison with the non-intervention group will be carried out.
*1 Community nursing: initiatives that contribute to physical, mental and social health and well-being by creating daily joys and pleasures together, close to where people live.
Basic objectives2
Others
Basic objectives -Others
Assess the following in community residents receiving community nursing.
-Health status
-Quality of life(EQ-5D)
-Changes due to engagement with community nurses*2
-Connections between people.
*2 Community nurses: a concept originally proposed and promoted by CNC, Ltd. inspired by the nursing practice of community nursing.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Interdependent Happiness(1 year after the start of community nursing).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Community nursing
Interventions/Control_2
No Interventions
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Male and Female aged 18 and over.
The planned number of participants is 20 in total (10 each in the intervention and control groups).
Key exclusion criteria
Those who do not collect questionnaires at Baseline and 3 months will be excluded.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Yata |
Organization
CNC,Ltd.
Division name
Not applicable
Zip code
699-1311
Address
29 Kisukicho Kisuki, Unnan-shi, Shimane-ken
TEL
090-5263-6652
info@community-nurse.jp
Public contact
Name of contact person
| 1st name | Hidetaka |
| Middle name | |
| Last name | Sakakibara |
Organization
CNC,Ltd.
Division name
Not applicable
Zip code
699-1311
Address
29 Kisukicho Kisuki, Unnan-shi, Shimane-ken
TEL
070-4192-7145
Homepage URL
hidetaka.sakakibara@community-nurse.jp
Sponsor or person
Institute
CNC,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Not applicable
Address
Not applicable
Tel
Not applicable
Not applicable
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
| 2024 | Year | 11 | Month | 01 | 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
| 2024 | Year | 10 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | 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
| 2024 | Year | 10 | Month | 18 | Day |
Last modified on
| 2025 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063849
