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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028146
Receipt No. R000031748
Scientific Title development of the choice support care model in the everyday life for elderly people with mild moderate dementia
Date of disclosure of the study information 2017/07/09
Last modified on 2019/01/12

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Basic information
Public title development of the choice support care model in the everyday life for elderly people with mild moderate dementia
Acronym everyday life choice support care in elderly people with dementia
Scientific Title development of the choice support care model in the everyday life for elderly people with mild moderate dementia
Scientific Title:Acronym everyday life choice support care in elderly people with dementia
Region
Japan

Condition
Condition elderly people with demantia
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 examination of the likelihood of the everyday life support care to elderly people institution elderly people with demantia entering
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes self-esteem,cognitive function,digital pulse wave
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Pseudo-randomization

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 We set it with one month for the follow-up period and intervene for two months for the operation period for one month for the basic standard period. A researcher conducts the data collection of the personal seat of elderly people in institution with information from a care provider. The investigation contents of elderly people in institution describe a reason to reach the institution entrance during age, sex, a clinical history, a medical history, the internal use situation, a need of nursing care degree, an institution entrance period in the personal attribute. For intelligence time before and after the care model intervention, the BPSD score of the elderly institution user is 1.4 weeks for the five times of eyes, a follow-up phase for1.2.4.6.8 week for the operation period for 4.1 weeks for the basic standard period. For the data collection time of other investigation items, we wrote it down in table 2. The investigation item is a depression standard (GDS) for old men, self-esteem (PGC moral survey scale), a cognitive function (MMSE, BPSD score), an everyday life independence degree (elderly people with dementia everyday life independence degree, elderly people with disorder everyday life independence degree, need of nursing care degree). The investigation item of the care provider does rianopu index and a care burden degree with measurement to eyes for 1.4 weeks for eyes, a follow-up phase for 1.2.4.6.8 week for eyes, the operation period for 1.4 weeks for the basic standard period.For the data collection time of other investigation items, it is from August, 2017 to December.
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

Not applicable
Gender Male and Female
Key inclusion criteria Intermediate elderly people slight degree with dementia entering a care health center for the elderly
Key exclusion criteria The person who cannot agree to study entry, the elderly people that it is difficult for the person that I cannot accept an agreement, communication to plan it with family do it with exclusion.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kozue Nakatani
Organization Chubu Gakuin College
Division name Diploma Course
Zip code
Address 2-1, Kirigaoka, Seki-shi, Gifu
TEL 0575-24-2211
Email nakatani@chubu-gu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kozue Nakatani
Organization Chubu Gakuin College
Division name Diploma Course
Zip code
Address 2-1, Kirigaoka, Seki-shi, Gifu
TEL 0575-24-2211
Homepage URL
Email nakatani@chubu-gu.ac.jp

Sponsor
Institute Chubu Gakuin College
Institute
Department

Funding Source
Organization Self-procurement
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 07 Month 09 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results are shown for 21 users and 26 care providers. As a result of comparing before and after the intervention by the user, only MMSE showed a significant increase in rank test of Wilcoxon test.
As a result of comparing before and after the care provider's intervention, occupational stress (physical condition), job satisfaction, a sense of desire to live, care frequency frequently increased. The maximum Lyapunov exponent of the finger pulse wave also increased significantly by the intervention in the Friedman test.
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 Completed
Date of protocol fixation
2017 Year 07 Month 09 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 09 Day
Last follow-up date
2017 Year 10 Month 30 Day
Date of closure to data entry
2017 Year 12 Month 15 Day
Date trial data considered complete
2018 Year 05 Month 10 Day
Date analysis concluded
2018 Year 09 Month 15 Day

Other
Other related information Selective support care was able to increase job satisfaction by care model intervention for care providers.

Management information
Registered date
2017 Year 07 Month 09 Day
Last modified on
2019 Year 01 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031748

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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