UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043843 |
|---|---|
| Receipt number | R000050038 |
| Scientific Title | Effectiveness of Individual Reminiscence Interventions in Using Life Storybooks on Persons with Dementia |
| Date of disclosure of the study information | 2021/04/10 |
| Last modified on | 2021/04/05 13:44:43 |
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Basic information
Public title
Effectiveness of Individual Reminiscence Interventions in Using Life Storybooks on Persons with Dementia
Acronym
Effectiveness of Individual Reminiscence Interventions in Using Life Storybooks on Persons with Dementia
Scientific Title
Effectiveness of Individual Reminiscence Interventions in Using Life Storybooks on Persons with Dementia
Scientific Title:Acronym
Effectiveness of Individual Reminiscence Interventions in Using LSB on PWD
Region
| Japan |
Condition
Condition
Persons with dementia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of individual reminiscence interventions in using life storybooks on persons with 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 and Behavioral and Psychological Symptoms of Dementia/4 weeks from start of intervention
Key secondary outcomes
care burden
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The intervention group by 4 weeks individual reminiscence in using life storybooks
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who have a formal diagnosis of dementia, and ability to hold on a simple conversation.
Key exclusion criteria
Those who have a psychological diagnosis other than dementia or difficulty using Life storybooks due to severe hearing loss or visual impairments.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Tomoaki |
| Middle name | |
| Last name | Asano |
Organization
Akita University,
Graduate School of Health Science
Division name
Department of Occupational Therapy
Zip code
010-8543
Address
1-1-1 Hondo, Akita
TEL
018-884-6536
tasano@hs.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoaki |
| Middle name | |
| Last name | Asano |
Organization
Akita University, Graduate School of Health Science
Division name
Department of Occupational Therapy
Zip code
010-8543
Address
1-1-1 Hondo, Akita
TEL
018-884-6536
Homepage URL
tasano@hs.akita-u.ac.jp
Sponsor or person
Institute
Akita University,
Graduate School of Health Science
Department of Occupational Therapy
Institute
Department
Personal name
Funding Source
Organization
Japanese grant-for-aid for scientific research(16K01563)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Tohoku Bunka Gakuen University
Address
6-45-1 Kunimi Sendai Miyagi
Tel
022-233-3310
tasano@hs.akita-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
介護老人保健施設翠香苑（秋田県），介護老人保健施設三楽園（秋田県），介護老人保健施設照隅苑（秋田県），介護老人保健施設清遊園（秋田県），介護老人保健施設あまさぎ園（秋田県），小規模多機能型居宅介護施設グリーンケアガーデン（秋田県），特別養護老人ホームりんどう苑（宮城県），特別養護老人ホーム清風苑（宮城県），グループホームあまさぎ園（秋田県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 10 | Day |
Related information
URL releasing protocol
https://journals.sagepub.com/doi/full/10.1177/0308022620945932
Publication of results
Published
Result
URL related to results and publications
https://journals.sagepub.com/doi/full/10.1177/0308022620945932
Number of participants that the trial has enrolled
66
Results
LSBs Interventions maintain cognition in participants with moderate to severe dementia and reduce BPSD and caregiver burden.
Results date posted
| 2021 | Year | 04 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 08 | Month | 25 | Day |
Baseline Characteristics
Those who have dementia and are using long-term care insurance facilities.
Participant flow
After the baseline assessment, the participants took life review interviews. After that, the individual intervention was conducted for 4 weeks using the life storybooks. The control group received the same care as the intervention group, except for the intervention with LSB.
Both groups underwent a final evaluation after 6 months.
Adverse events
None
Outcome measures
Cognitive functions
Behavioral and Psychological Symptoms of Dementia
Care burden
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 07 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 04 | Day |
Date of closure to data entry
| 2018 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 09 | Month | 30 | Day |
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 04 | Month | 05 | Day |
Last modified on
| 2021 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050038
