UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031701 |
|---|---|
| Receipt number | R000036206 |
| Scientific Title | The effects of reminiscence practice on care prevention in community-dwelling elderly people |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2020/03/20 14:17:56 |
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Basic information
Public title
The effects of reminiscence practice on care prevention in community-dwelling elderly people
Acronym
The effects of reminiscence practice in community-dwelling elderly people
Scientific Title
The effects of reminiscence practice on care prevention in community-dwelling elderly people
Scientific Title:Acronym
The effects of reminiscence practice in community-dwelling elderly people
Region
| Japan |
Condition
Condition
Community-dwelling elderly people
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Community-dwelling elderly people are randomly put into an intervention group or a control group. In the intervention group, reminiscence is carried out using olfactory stimulation. In the control group, reminiscence is carried out using word cards.
The purpose of this research is to determine the effectiveness of olfactory stimulation in reminiscence intervention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Geriatric Depression Scale-15
Evaluations were performed at two points; baseline and after intervention.
Key secondary outcomes
Five Cognitive Test
Evaluations were performed at two points; baseline and after intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Intervention Group: Reminiscence is carried out weekly using olfactory stimulation as the reminiscence cue for twelve sessions (40 min).
Interventions/Control_2
Control Group: Reminiscence is carried out weekly using word cards as the reminiscence cue for twelve sessions (40 min).
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
1. Subjects over 65 years of age
2. Subjects living in the community
3. Subjects who are able to attend without any help
4. Subjects that provided informed consent
Key exclusion criteria
1. Subjects under long-term care insurance
2. Subjects with smell disorders
3. Subjects who have problems with hearing, vison, or language in group activities
4. Subjects who are assessed by the principal investigator or primary doctor due to other reasons
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Hanaoka |
Organization
Hiroshima University
Division name
Graduate School of Biomedical & Health Sciences
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5400
hhanaoka@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shingo Yamane |
Organization
Hiroshima University
Division name
Graduate School of Biomedical & Health Sciences
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5417
Homepage URL
shingoyamane@hiroshima-u.ac.jp
Sponsor or person
Institute
Graduate School of Biomedical & Health Sciences, Hiroshima University
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
Japan
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 01 | 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
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 14 | Day |
Last follow-up date
| 2019 | Year | 01 | 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
| 2018 | Year | 03 | Month | 13 | Day |
Last modified on
| 2020 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036206
