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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029190
Receipt No. R000033372
Scientific Title Evaluation of the Reminiscence program for the elderly people
Date of disclosure of the study information 2017/11/28
Last modified on 2017/11/28

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Basic information
Public title Evaluation of the Reminiscence program for the elderly people
Acronym Evaluation of the Reminiscence program for the elderly people
Scientific Title Evaluation of the Reminiscence program for the elderly people
Scientific Title:Acronym Evaluation of the Reminiscence program for the elderly people
Region
Japan

Condition
Condition None
Classification by specialty
Hematology and clinical oncology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify changes in the QOL among the elderly people who participate in the Reminiscence program and to evaluate the impact of the program on the elderly people.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes EQ-5D-5L
Key secondary outcomes 1.Visual Analogue Scale
2.Mini-Mental State Examination
3.The Self-administered Dementia Checklist
4.Functional Independence Measure
5.Face scale
6.Focus group interview with staff who provide the Reminiscence program

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 Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention groups: To provide the 20 minutes weekly Reminiscence program for a year.
Interventions/Control_2 Control groups: To provide the regular program.
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 Elderly over 65 years of age.
Key exclusion criteria None
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akiko Sasaki
Organization Tokyo Medical and Dental University
Division name Community Health Nursing
Zip code
Address 1-5-45, yushima, bunkyo-ku, tokyo, Japan
TEL 03-5803-5350
Email sasaki.phn@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akiko Sasaki
Organization Tokyo Medical and Dental University
Division name Community Health Nursing
Zip code
Address 1-5-45, yushima, bunkyo-ku, tokyo, Japan
TEL 03-5803-5350
Homepage URL
Email sasaki.phn@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Community Health Nursing
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
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
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 11 Month 28 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
2017 Year 11 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 28 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
2017 Year 09 Month 19 Day
Last modified on
2017 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033372

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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