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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Elderly people over 65 years old in community-dwelling | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Organization | Osaka medical college | ||||||
Division name | Nursing | ||||||
Zip code | 569-0095 | ||||||
Address | 7-6, Haccho-nichimachi, Takatsuki, Osaka, JAPAN | ||||||
TEL | 072-683-1221 | ||||||
fon172@osaka-med.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |