UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043003
Receipt number 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 2024/01/17 12:40:22

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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 or person

Institute

Osaka medical college

Institute

Department

Personal name



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

Enrolling by invitation

Date of protocol fixation

2021 Year 04 Month 01 Day

Date of IRB

2021 Year 03 Month 05 Day

Anticipated trial start date

2021 Year 04 Month 01 Day

Last follow-up date

2025 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

2024 Year 01 Month 17 Day



Link to view the page

Value
https://center6.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