UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055378 |
|---|---|
| Receipt number | R000063264 |
| Scientific Title | Research on the development of sleep quality improvement services through health and nutrition guidance |
| Date of disclosure of the study information | 2024/08/31 |
| Last modified on | 2025/02/28 15:24:36 |
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Basic information
Public title
Research on the development of sleep quality improvement services through health and nutrition guidance
Acronym
Research on the development of sleep quality improvement services through health and nutrition guidance
Scientific Title
Research on the development of sleep quality improvement services through health and nutrition guidance
Scientific Title:Acronym
Research on the development of sleep quality improvement services through health and nutrition guidance
Region
| Japan |
Condition
Condition
senior citizen
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to develop a service that improves the quality of sleep for elderly people through health and nutritional guidance provided by nurses and registered dietitians.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of sleep after nutrition/health guidance
Key secondary outcomes
Sleep quality based on questionnaire survey
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Nutrition and health guidance by a nurse who has received guidance from a registered dietitian
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Elderly people aged 65 and over who live in Matsuyama City, Ehime Prefecture and have trouble sleeping.
Those who have received a sufficient explanation of the purpose and content of this research, have the capacity to consent, understand it well, wish to participate in the research voluntarily, and can consent to this research in writing.
Key exclusion criteria
Those who cannot fully understand the contents of this demonstration
Other people who are deemed unsuitable by the research director/co-investigator
Target sample size
17
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Fukasawa |
Organization
Nurse and Craft Co., Ltd.
Division name
Representative director
Zip code
734-0304
Address
2312 Kubi, Toyomachi, Kure City, Hiroshima Prefecture
TEL
0823-66-5425
hello@nurseandcraft.io
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Fukasawa |
Organization
Nurse and Craft Co., Ltd.
Division name
Representative director
Zip code
734-0304
Address
2312 Kubi, Toyomachi, Kure City, Hiroshima Prefecture
TEL
0823-66-5425
Homepage URL
hello@nurseandcraft.io
Sponsor or person
Institute
Nurse and Craft Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Nurse and Craft Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Review Committee
Address
Meieki Diamatetsu Building 11F, 1-1-17 Meieki, Nishi-ku, Nagoya, Aichi Prefecture
Tel
080-5055-3551
hagiwara.keitaro@yuurea.co.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
| 2024 | Year | 08 | Month | 31 | 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
Completed
Date of protocol fixation
| 2024 | Year | 08 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 08 | 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 | 08 | Month | 30 | Day |
Last modified on
| 2025 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063264
