UMIN-CTR Clinical Trial

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
Email	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
Email	tasano@hs.akita-u.ac.jp

Sponsor
Institute	Akita University, Graduate School of Health Science Department of Occupational Therapy
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050038