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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043003
Receipt No. R000049095
Scientific Title Verification of the long-term effects of nursing intervention on sleep disturbances in the community-dwelling elderly
Date of disclosure of the study information 2021/01/14
Last modified on 2021/01/14

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Basic information
Public title Verification of the long-term effects of nursing intervention on sleep disturbances in the community-dwelling elderly
Acronym Verification of the long-term effects of nursing intervention on sleep disturbances in the community-dwelling elderly
Scientific Title Verification of the long-term effects of nursing intervention on sleep disturbances in the community-dwelling elderly
Scientific Title:Acronym Verification of the long-term effects of nursing intervention on sleep disturbances in the community-dwelling elderly
Region
Japan

Condition
Condition Elderly people over 65 years old in community-dwelling
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the long-term effects of educational nursing interventions about improving sleep disturbances for community-dwelling elderly people.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sleep parameters (sleep time, bedtime, number of awakening, sleep efficiency)
Key secondary outcomes amount of social activity

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Educational nursing interventions related to sleep based on monitoring data (eg, objectively self viewing-sleep data, setting appropriate sleep onset time, managing sleep environment, adjusting daytime activity level, etc.)
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
100 years-old >
Gender Male and Female
Key inclusion criteria Elderly people aged 65 and over who are independent mobile, can have undergone educational nursing intervention, and have not interfered with their daily lives in their eyesight, hearing, and language ability to keep a daily life diary.
Key exclusion criteria Person who need assisst for daily living because of psychiatric or cerebrovascular disease, cognitive impairment, visual and hearing impairment
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Yoko
Middle name
Last name Higami
Organization Osaka medical college
Division name Nursing
Zip code 569-0095
Address 7-6, Haccho-nichimachi, Takatsuki, Osaka, JAPAN
TEL 072-683-1221
Email fon172@osaka-med.ac.jp

Public contact
Name of contact person
1st name Yoko
Middle name
Last name Higami
Organization Osaka medical college
Division name Nursing
Zip code 569-0095
Address 7-6, Haccho-nichimachi, Takatsuki, Osaka, JAPAN
TEL 072-683-1221
Homepage URL
Email fon172@osaka-med.ac.jp

Sponsor
Institute Osaka medical college
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research
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 Osaka Medical College IRB
Address 2-7, Daigakumachi, Takatsuki, Osaka, JAPAN
Tel 072-683-1221
Email none

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 01 Month 14 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
2021 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2021 Year 04 Month 01 Day
Last follow-up date
2023 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
2021 Year 01 Month 14 Day
Last modified on
2021 Year 01 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049095

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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