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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050038


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name