UMIN-CTR Clinical Trial

Basic information
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
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

Objectives
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

Assessment
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

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute	Ritsumeikan University
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Muko City Office Yoshimoto Kogyo Co National Center for Geriatrics and Gerontology
Name of secondary funder(s)

IRB Contact (For public release)
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
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
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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

Progress
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
Other related information

Management information
Registered date	2022 Year 07 Month 26 Day
Last modified on	2022 Year 07 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055202