UMIN-CTR Clinical Trial

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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