UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021966
Receipt number R000025324
Scientific Title Project for Promotion of Community Care Program for People Living With Dementia
Date of disclosure of the study information 2016/09/01
Last modified on 2018/05/29 17:20:59

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Basic information

Public title

Project for Promotion of Community Care Program for People Living With Dementia

Acronym

Development of Japanese version of BPSD Program of Care

Scientific Title

Project for Promotion of Community Care Program for People Living With Dementia

Scientific Title:Acronym

Development of Japanese version of BPSD Program of Care

Region

Japan


Condition

Condition

Dementia

Classification by specialty

Geriatrics Psychiatry Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of Japanese version of BPSD Program of Care that has been developed in Sweden to promote psychosocial approaches to challenging behaviors of people with dementia.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Frequency and severity of challenging behavior among people with dementia

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

A professional caregiver evaluates frequency and severity of challenging behavior of a person with dementia. Based on the measurement, the caregiver establishes a care plan of daily program that includes contents and frequency of basic communication approach, physical activity, calm environment, massage, music/song, and so on. The caregiver implements the program according to the care plan, and re-evaluates the challenging behavior.

Interventions/Control_2

A professional caregiver evaluates frequency and severity of challenging behavior of a person with dementia. The caregiver does not establish a care plan, either implement the program.

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

A client of participating long-term care providers and has a diagnosis of dementia
6-10 clients from one providers who started the use of service most recently.

Key exclusion criteria

Younger than 65 years old

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Miharu Nakanishi

Organization

Tokyo Metropolitan Institute of Medical Science

Division name

Mental Health Promotion project

Zip code


Address

2-1-6 Kamikitazawa, Setagaya-ku, Tokyo 156-8506 JAPAN

TEL

+81-3-6834-2292

Email

nakanishi-mh@igakuken.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kaori Endo

Organization

Tokyo Metropolitan Institute of Medical Science

Division name

Mental Health Promotion Project

Zip code


Address

2-1-6 Kamikitazawa, Setagaya-ku, Tokyo 156-8506 JAPAN

TEL

+81-3-6834-2294

Homepage URL


Email

endo-kr@igakuken.or.jp


Sponsor or person

Institute

Tokyo Metropolitan Institute of Medical Science

Institute

Department

Personal name



Funding Source

Organization

Tokyo Metropolitan government

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2016 Year 09 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://dx.doi.org/10.3233/JAD-171077

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

2016 Year 02 Month 19 Day

Date of IRB


Anticipated trial start date

2016 Year 09 Month 01 Day

Last follow-up date

2017 Year 10 Month 31 Day

Date of closure to data entry

2017 Year 10 Month 31 Day

Date trial data considered complete

2017 Year 12 Month 31 Day

Date analysis concluded

2018 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2016 Year 04 Month 18 Day

Last modified on

2018 Year 05 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025324


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name