UMIN-CTR Clinical Trial

Public title

Efficacy of psychosocial education support programs for people with mild cognitive impairment, dementia, and their family caregivers: a pilot study for a randomized assignment trial

Acronym

Petit-Shoten Study: A pilot study

Scientific Title

Efficacy of psychosocial education support programs for people with mild cognitive impairment, dementia, and their family caregivers: a pilot study for a randomized assignment trial

Scientific Title:Acronym

Petit-Shoten Study: A pilot study

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

Pilot study for "Efficacy of psychosocial education support programs for people with mild cognitive impairment, dementia, and their family caregivers: Randomized controlled trials" (production trial). To confirm feasibility of the program as a preliminary step to the production trial.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Satisfaction with program participation (individual and family): Visual Analogue Scale (VAS)

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. Temporary Mood Scale

4. DEMQOL-Proxy

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

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

7. Qualitative evaluation of the program

[Family caregiver]
1. Depression evaluation
The Center for Epidemiologic Studies Depression Scale Japanese version (CES-D)

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

3. Temporary Mood Scale

4. Care Environment Assessment: Dementia Care Condition Rating Scale

5. QOL: SF-36 v2

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

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

8.Qualitative evaluation of the program

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

1: Participate in pairs of people with mild cognitive impairment, dementia, and their families.

2: Psychosocial education support program setting: Multi-component composition by interdisciplinary approach (6 sessions: 3 music session and 3 comic dialogue session)

3:Duration of this program: 6 times per session once every 2 weeks (120 minutes), 12 weeks

4: Family members will be provided with a 60-minute separation session out of the 120-minute session to observe and share their impressions of the person while attending the session, and to conduct group work to learn from each other about how to deal with people with MCI and dementia and how to protect themselves and their caregivers through discussions with participants and care professionals.

Interventions/Control_2

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, 3, 4 or 5 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)Those who requested participation through the NCGG website or posters posted in NCGG
(4)Those who have requested participation through the publicity of the Muko City Hall and the Muko City North, Central, and South Regional Comprehensive Support Centers in Muko City, Kyoto Prefecture.
(5)Those who are currently being supported by a dementia community support promoter or care manager at a comprehensive support center in the northern, central, or southern part of Muko City, Kyoto Prefecture, or at an in-home care support office in Muko City.

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
(4) Family members who primarily provide care (help and assistance) necessary for daily living to persons with mild cognitive impairment or mild to moderate dementia.

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 are unable to give consent or substitute consent for the research
(7) Living in the Nursing Home
(8) Those who participate in NCGG's brain/body activation rehabilitation program and art appreciation self-expression program

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
(8) Those who are caregivers other than family members who are the primary caregivers

Target sample size

10

Name of lead principal investigator

1st name	Aya
Middle name
Last name	Seike

Organization

RITSUMEIKAN UNIVERSITY

Division name

SPORT AND HEALTH SCIENCE

Zip code

525-0058

Address

1-11 Noji-Higashi Kusatsu, Siga

TEL

077-561-3760

Email

seike.aya.w77@kyoto-u.jp

Name of contact person

1st name	Aya
Middle name
Last name	Seike

Organization

RITSUMEIKAN UNIVERSITY

Division name

SPORT AND HEALTH SCIENCE

Zip code

525-0058

Address

1-11 Noji-Higashi Kusatsu, Siga

TEL

077-561-3760

Homepage URL

Email

seike.aya.w77@kyoto-u.jp

Institute

Ritsumeikan University

Institute

Department

Personal name

Organization

Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Muko City Office
Yoshimoto Kogyo Co
National Center for Geriatrics and Gerontology

Name of secondary funder(s)

Organization

National Center for Geriatrics and Gerontology

Address

7-430,Morioka-cho,Ohbu City, Aichi

Tel

0562-46-2311

Email

yaday@ncgg.go.jp

Secondary IDs

YES

Study ID_1

1545-1

Org. issuing International ID_1

National Center for Geriatrics and Gerontology

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

07

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

10

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

No longer recruiting

Date of protocol fixation

2021

Year

07

Month

30

Day

Date of IRB

2021

Year

07

Month

30

Day

Anticipated trial start date

2021

Year

10

Month

15

Day

Last follow-up date

2022

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

07

Month

26

Day

Last modified on

2022

Year

07

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055202