UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043713 |
|---|---|
| Receipt number | R000049777 |
| Scientific Title | Examination of night excretion care aiming at improvement of the sleep / wake rhythm of elderly people entering long-term care insurance facilities |
| Date of disclosure of the study information | 2021/05/01 |
| Last modified on | 2021/03/18 11:38:20 |
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Basic information
Public title
Study of night excretion aiming at improvement of the sleep-wake rhythm of the elderly
Acronym
Study of night excretion aiming at improvement of the sleep-wake rhythm of the elderly
Scientific Title
Examination of night excretion care aiming at improvement of the sleep / wake rhythm of elderly people entering long-term care insurance facilities
Scientific Title:Acronym
Examination of night excretion care aiming at improvement of the sleep / wake rhythm of elderly people entering long-term care insurance facilities
Region
| Japan |
Condition
Condition
Irregular sleep-wake rhythm disorder
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the frequency of night-time diaper changes conducted at fixed times at nursing care insurance facility was reduced from per night and the resulting changes in sleep variables were considered along with the characteristics of the elderly residents, with the goal of acquiring hints for diaper-changing methods that could improve sleep quality.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Decrease in wake after sleep onset
Key secondary outcomes
changes in sleep variables
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
the frequency of night-time diaper changes conducted at fixed times at a single nursing care insurance facility was reduced from twice to once per night and the resulting changes in sleep variables were considered along with the characteristics of the elderly residents,
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
Consent to research
Entering a long-term care insurance facilities
Change diapers at night
Key exclusion criteria
Skin disorders
Sleeping disorder
Urinary disorders
Posture change
Planning to leave the facility
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Madoka |
| Middle name | |
| Last name | Konishi |
Organization
St.Catherine University
Division name
Department of Nursing
Zip code
790-0022
Address
1-10 Eidaicyo,Matuyama
TEL
0899470502
konishi@catherine.ac.jp
Public contact
Name of contact person
| 1st name | Madoka |
| Middle name | |
| Last name | Konishi |
Organization
St.Catherine University
Division name
Department of Nursing
Zip code
790-0022
Address
1-10 Eidaicyo,Matuyama
TEL
0899470502
Homepage URL
konishi@catherine.ac.jp
Sponsor or person
Institute
Osaka City University
Institute
Department
Personal name
Funding Source
Organization
the Japan Society for the Promotion of Science
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
Osaka City University
Address
1-5-17 Asahi-machi, Abeno-ku, Osaka
Tel
0666453548
d16na001@yf.osaka-cu.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
| 2021 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2021 | Year | 03 | Month | 23 | Day |
Last modified on
| 2021 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049777
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
