UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033242 |
|---|---|
| Receipt number | R000037178 |
| Scientific Title | Effects of activity care for the elderly aged 75 or over in acute hospital |
| Date of disclosure of the study information | 2018/07/10 |
| Last modified on | 2018/07/02 15:41:29 |
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Basic information
Public title
Effects of activity care for the elderly aged 75 or over in acute hospital
Acronym
Effects of activity care for the elderly aged 75 or over in acute hospital
Scientific Title
Effects of activity care for the elderly aged 75 or over in acute hospital
Scientific Title:Acronym
Effects of activity care for the elderly aged 75 or over in acute hospital
Region
| Japan |
Condition
Condition
elderly aged 75 or over
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
TO evaluate the efficacy of activity care for living functions of the elderly aged 75 or over in acute hospital
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mini Mental State Examination
Within 3 days from hospitalization, at the time of discharge or 4 weeks after from hospitalization.
Key secondary outcomes
Vitality Index
Barthes Index
Satisfaction with participation in activity care
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
The participants were divided into two groups.
For intervention group, we provide the activity care twice a week, once an hour in addition to usual nursing plan.
Interventions/Control_2
For control group, we provide usual nursing plan.
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Elderly patients(over 75 years oider).
(2)Patients who ADL was independent before hospitalization.
(3)Patients who isn't diagnosed as dementia.
(4)Patients who judged that bed rest wasn't necessary.
(5)Patients who permitted the activity care from the attending physician.
(6)Patients who understand the purpose of the research and obtained informed consent.
Key exclusion criteria
Patients judging that participation in this study is not suitable for researchers.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Miho Tsujino |
Organization
Graduate School of Medicine, Mie University
Division name
Gerontological nursing course
Zip code
Address
2-174 Edobashi, Tsu city, Mie prefecture
TEL
059-232-1111
316m107@m.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miho Tsujino |
Organization
Graduate School of Medicine, Mie University
Division name
Gerontological nursing course
Zip code
Address
2-174 Edobashi, Tsu city, Mie prefecture
TEL
059-232-1111
Homepage URL
316m107@m.mie-u.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
Funding Source
Organization
Mie University
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
Address
Tel
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
独立行政法人地域医療機能推進機構 中京病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 10 | 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
| 2018 | Year | 05 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 02 | Day |
Last modified on
| 2018 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037178
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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