UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029749 |
|---|---|
| Receipt number | R000033988 |
| Scientific Title | Effect verification of reminiscence method in the miniature garden |
| Date of disclosure of the study information | 2017/10/30 |
| Last modified on | 2018/10/30 10:22:03 |
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Basic information
Public title
Effect verification of reminiscence method in the miniature garden
Acronym
Reminiscence method in the miniature garden
Scientific Title
Effect verification of reminiscence method in the miniature garden
Scientific Title:Acronym
Reminiscence method in the miniature garden
Region
| Japan |
Condition
Condition
Mild cognitive impairment
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prophylactic intervention of dementia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement of cognitive function's score/3 months from start of intervention
Key secondary outcomes
Psychological well-being
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
The intervention group by Reminiscence method in the miniature garden
Interventions/Control_2
Non-intervention group
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
| 60 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who can go on their own until the district public hall of the implementation location.
Key exclusion criteria
Those who can not go to the district public hall by themselves.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazue Sawami |
Organization
Nara Medical University
Division name
Faculty of Nursing
Zip code
Address
840 Shijo, Kashihara, Nara JAPAN
TEL
0744-22-3051
sawami@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazue Sawami |
Organization
Nara Medical University
Division name
Faculty of Nursing
Zip code
Address
840 Shijo, Kashihara, Nara JAPAN
TEL
0744-22-3051
Homepage URL
http://www.g-nursing.com/katsudou.php
sawami@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical 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
橿原市公民館
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://www.nurse.or.jp/up_pdf/20180905134941_76.pdf
Number of participants that the trial has enrolled
Results
Data analysis is completed.
Mood scale (statistically significant) affecting cognitive function was extracted.
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
Main results already published
Date of protocol fixation
| 2017 | Year | 10 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 10 | Month | 14 | Day |
Date analysis concluded
| 2018 | Year | 10 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 29 | Day |
Last modified on
| 2018 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033988
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
