UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050929 |
|---|---|
| Receipt number | R000057752 |
| Scientific Title | Exploratory study on the effect of reminiscences to help prevent care for elderly people living in communities |
| Date of disclosure of the study information | 2023/05/01 |
| Last modified on | 2025/11/25 14:58:15 |
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Basic information
Public title
Study on effects of reminiscences to prevent care for elderly residents living in the community
Acronym
Effects of reminiscences for community-based elderly
Scientific Title
Exploratory study on the effect of reminiscences to help prevent care for elderly people living in communities
Scientific Title:Acronym
Study of the effectiveness of reminiscence using olfactory stimulation
Region
| Japan |
Condition
Condition
Community-based elderly
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effectiveness of group reminiscence using olfactory stimulation for elderly people living in local areas.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of change in GDS-15 score after intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Interventions: Group reminiscence is carried out eight times at each venue, using olfactory stimulation to stimulate recollections at a frequency of once a week (about 40 minutes).
Interventions/Control_2
Control group: Group reminiscence is conducted eight times at each venue, each time with a theme set at a frequency of once a week (about 40 minutes).
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) Persons 65 years of age or older at the time of obtaining consent
(2) People who live in the area (not in a facility)
(3) Those who can visit the place of implementation by themselves.
(4) Those who obtain written consent for participation in this study from the person in question.
Key exclusion criteria
(1) A person who receives nursing care benefits (Needed Long-Term Care 1 or more) from nursing care insurance
(2) People with olfactory disorders (suspected olfactory disorders in olfactory function screening tests)
(3) Those who have difficulty communicating in implementing the recollections.
(4) Those who recognized cognitive impairment
(5) Other persons deemed inappropriate by the person in charge of research or the research collaborator
Target sample size
128
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Hanaoka |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Sciences
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5400
hhanaoka@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Hanaoka |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Sciences
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5400
Homepage URL
hhanaoka@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research Japan society of 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
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-Ku, Hiroshima 734-8551
Tel
082-257-1947
iryo-sinsa@office.hiroshima-u.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
| 2023 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1111/psyg.70037
Publication of results
Partially published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/psyg.70037
Number of participants that the trial has enrolled
79
Results
Following the conclusion of the intervention, an examination of the differences between the two groups in the change in scores on each assessment scale before and after the intervention (two time points) revealed a significant interaction only for the UCLA LS3.
Subsequently, an assessment was also conducted three months after the end of the intervention. The results showed no significant interaction effects for any of the outcomes.
Results date posted
| 2025 | Year | 11 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We requested that the operators of regional long-term care preventive services through Community-Based Integrated Care Centers help with participant recruitment. We explained the study and participant recruitment to the business operators. Eligible participants were (1) individuals aged 65 years and older, (2) those living in a community, (3) those who were able to travel to the study venue by themselves, and (4) those who provided written consent to participate. Exclusion criteria were (1) individuals receiving nursing care benefits (Care Level 1 or higher) under the long-term care insurance system, (2) those who had difficulty smelling during reminiscence therapy due to olfactory disorders, (3) those who had difficulty communicating during reminiscence therapy, and (4) those experiencing cognitive function disorder.
Participant flow
Seventy-nine individuals met the inclusion criteria. By the completion of the eight intervention sessions, ten participants had dropped out from the intervention group: seven due to non-completion of assessments and three due to ill health preventing participation. In the control group, 5 individuals were not assessed and 3 withdrew due to insufficient participation (5 or fewer session attendances), resulting in a total of 8 dropouts. The final number of participants analysed after the intervention was 30 in the intervention group and 31 in the control group. Subsequently, an assessment was conducted 3 months after the intervention ended. At this point, 28 participants in the intervention group and 23 in the control group were able to be assessed.
Adverse events
Nothing
Outcome measures
UCLA Loneliness Scale Version 3 (UCLA LS3), Geriatric Depression Scale-15-Japanese (GDS-15-J)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 04 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 26 | Day |
Last modified on
| 2025 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057752
