UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029190 |
|---|---|
| Receipt number | 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 | 2021/09/28 15:48:58 |
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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 | Akiko |
| Middle name | |
| Last name | Sasaki |
Organization
Tokyo Medical and Dental University
Division name
Community Health Nursing
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5350
sasaki.phn@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Sasaki |
Organization
Tokyo Medical and Dental University
Division name
Community Health Nursing
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5350
Homepage URL
sasaki.phn@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Community Health Nursing
Institute
Department
Personal name
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
Tokyo Medical and Dental University,General Affairs Devision, School of Medicine
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
Tel
03-5803-5096
syomu1.adm@tmd.ac.jp
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
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
148
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
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
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
| 2021 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033372
