UMIN-CTR Clinical Trial

Public title

Efficacy of psychosocial education support programs for people with mild cognitive impairment, dementia, and their family caregivers: Randomized controlled trials

Acronym

Efficacy of psychosocial education support programs for people with mild cognitive impairment, dementia, and their family caregivers: Randomized controlled trials

Scientific Title

Efficacy of psychosocial education support programs for people with mild cognitive impairment, dementia, and their family caregivers: Randomized controlled trials

Scientific Title:Acronym

Efficacy of psychosocial education support programs for people with mild cognitive impairment, dementia, and their family caregivers: Randomized controlled trials

Region

Japan

Condition

1. Mild cognitive impairment, mild to moderate dementia
2. Family caregivers of people with mild cognitive impairment and mild to moderate dementia

Classification by specialty

Neurology	Geriatrics	Psychiatry
Nursing	Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Verification of the effectiveness of a psychosocial education support program for people with mild cognitive impairment, dementia, and their family caregivers

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Primary outcomes

The stress responses: Depression(The Center for Epidemiologic Studies Depression Scale; CES-D)

Key secondary outcomes

[People with mild cognitive impairment and dementia]
1. Cognitive function evaluation
A: Cognitive function: Mini-Mental State Examination Japanese version (MMSE-J)
B: Clinical Dementia Rating --Japanese (CDR-J)

2. Activities of daily living
A: Daily Living Ability: Lawton Instrumental Activities of Daily Living
B: Activities of daily living: Barthel Index

3. Relationship satisfaction scale (People with mild cognitive impairment and dementia-caregiver), using VAS

4. Evaluation of program-participation
A: Program attendance rate
B: Satisfaction of program participation, using VAS
C: Willingness of program participation (next time), using VAS

5. Qualitative evaluation of the program

[Family caregiver]
1. Depression evaluation
A: The Center for Epidemiologic Studies Depression Scale Japanese version (CES-D)
B: Patient Health Questionnaire 9 Japanese version (PHQ-9)

2.Long-term care burden: Zarit burden Interview Japanese version (J-ZBI)

3.Personal-caregiver relationship satisfaction: Visual Analogue Scale (VAS)

4.Evaluation of program-participation
A: Program attendance rate
B: Satisfaction of program participation, using VAS
C: Willingness of program participation (next time), using VAS

5.Qualitative evaluation of the program

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Maneuver

Interventions/Control_1

Intervention group:
(1) Psychosocial education support program setting: Multi-component composition by interdisciplinary approach (6 sessions: 1 session in the medical field, 1 session in the care area, 1 session in the welfare area, 1 session in the psychology area, 2 sessions in the recreation-care area)

(2) Duration of this program: 6 times per session once every 2 weeks (90 minutes), 12 weeks in total

(3) Participate in pairs of people with mild cognitive impairment, dementia, and their families.

Interventions/Control_2

Control group:
(1)Materials select from "First Steps (Classroom Textbooks for People with Dementia and Family Caregivers)" and "For Family Caregivers Supporting People with Dementia" distributed at the National Center for Geriatrics and Gerontology
(2)These materials will be mailed 6 times every 2 weeks at the same time as the intervention group session.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

65

years-old

<=

Age-upper limit

90

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. People with mild dementia, mild to moderate dementia
Those aged 65 to 90 who have been clinically diagnosed with mild cognitive impairment or mild to moderate dementia (MMSE 15 points or higher) who fall under any of the following 1, 2, or 3 are continuing to live at home. Those who have agreed to participate in this study
(1)Those who are outpatient at the national center for Geriatric and Gerontology.
(2)Persons receiving support from those who have completed the classroom (family) for family caregivers of people with dementia at the national center for Geriatric and Gerontology.
(3)External public relations those who wish to participate through poster posting at these agencies: NCGG homepage, posters of NCGG, Obu City, and Higashiura Town

2. Family caregivers
(1) Family caregivers of people with mild cognitive impairment and mild to moderate dementia living at home (20 to 90 years old)
(2) Family caregivers who can participate in the program with people with mild cognitive impairment and mild to moderate dementia every time
(3) Those who have agreed to participate in this study

Key exclusion criteria

1. People with mild dementia, people with mild to moderate dementia
(1) MMSE score is 14 points or less
(2) Persons with severe aphasia
(3) Persons with severe visual and hearing disabilities
(4) Persons with severe neurodegenerative diseases or mental disorders who are inappropriate for participation by the attending physician
(5) Those who have difficulty in long-term survival due to progressive diseases (cancer, etc.)
(6) Those who do not understand the purpose of the research
(7) Those who participate in NCGG's brain/body activation rehabilitation program and art appreciation self-expression program
(8) Living in the Nursing Home

2. Family caregiver
(1) Medical / long-term care professionals
(2) Persons with severe aphasia
(3) Persons with severe visual and hearing disabilities
(4) Persons with severe neurodegenerative diseases or mental disorders who are inappropriate for participation by the attending physician
(5) Those who have difficulty in long-term survival due to progressive diseases (cancer, etc.)
(6) Those who do not understand the purpose of the research
(7) Those who participate in NCGG's brain/body activation rehabilitation program and art appreciation self-expression program

Target sample size

100

Name of lead principal investigator

1st name	Aya
Middle name
Last name	Seike

Organization

Kyoto University

Division name

Kokoro Research Center

Zip code

606-8511

Address

46, Shimoadachi-cho Kyoto-city, Kyoto, Japan

TEL

075-753-9683

Email

seike.aya.6u@kyoto-u.ac.jp

Name of contact person

1st name	Keiko
Middle name
Last name	Hara

Organization

National Center for Geriatrics and Gerontology

Division name

The Center for Comprehensive Care and Research on Memory Disorders

Zip code

474-8511

Address

7-430, Morioka-cho Obu-city, Aichi, Japan

TEL

0562-87-2515

Homepage URL

Email

hendo2@ncgg.go.jp

Institute

National Center for Geriatrics and Gerontology

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

1.National Center for Geriatrics and Gerontology,2.Nagoya University,3.Tokyo Medical and Dental University,4.Zenbe Corporation

Name of secondary funder(s)

Organization

National Center for Geriatrics and Gerontology

Address

7-430, Morioka-cho Obu-shi, Aichi, Japan

Tel

0562-87-2515

Email

ayahime@ncgg.go.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

国立長寿医療研究センター（愛知県）

Date of disclosure of the study information

2021

Year

02

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

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

Recruitment status

Preinitiation

Date of protocol fixation

2020

Year

07

Month

15

Day

Date of IRB

Anticipated trial start date

2021

Year

03

Month

01

Day

Last follow-up date

2022

Year

07

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2021

Year

02

Month

16

Day

Last modified on

2021

Year

02

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048422