UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033242
Receipt No. R000037178
Official scientific title of the study 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study Effects of activity care for the elderly aged 75 or over in acute hospital
Title of the study (Brief title) 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 Miho Tsujino
Organization Graduate School of Medicine, Mie University
Division name Gerontological nursing course
Address 2-174 Edobashi, Tsu city, Mie prefecture
TEL 059-232-1111
Email 316m107@m.mie-u.ac.jp

Public contact
Name of contact person Miho Tsujino
Organization Graduate School of Medicine, Mie University
Division name Gerontological nursing course
Address 2-174 Edobashi, Tsu city, Mie prefecture
TEL 059-232-1111
Homepage URL
Email 316m107@m.mie-u.ac.jp

Sponsor
Institute Mie University
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 05 Month 25 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037178

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.