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UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043337
Receipt No. R000048422
Scientific Title Efficacy of psychosocial education support programs for people with mild cognitive impairment, dementia, and their family caregivers: Randomized controlled trials
Date of disclosure of the study information 2021/02/16
Last modified on 2021/02/16

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Basic information
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
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 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

Assessment
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

Base
Study type Interventional

Study design
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

Intervention
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

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, 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

Research contact person
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

Public contact
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

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
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)

IRB Contact (For public release)
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
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 国立長寿医療研究センター(愛知県)

Other administrative information
Date of disclosure of the study information
2021 Year 02 Month 16 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
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 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
Other related information

Management information
Registered date
2021 Year 02 Month 16 Day
Last modified on
2021 Year 02 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048422

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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