Unique ID issued by UMIN | UMIN000043337 |
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Receipt number | 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 12:24:35 |
Efficacy of psychosocial education support programs for people with mild cognitive impairment, dementia, and their family caregivers: Randomized controlled trials
Efficacy of psychosocial education support programs for people with mild cognitive impairment, dementia, and their family caregivers: Randomized controlled trials
Efficacy of psychosocial education support programs for people with mild cognitive impairment, dementia, and their family caregivers: Randomized controlled trials
Efficacy of psychosocial education support programs for people with mild cognitive impairment, dementia, and their family caregivers: Randomized controlled trials
Japan |
1. Mild cognitive impairment, mild to moderate dementia
2. Family caregivers of people with mild cognitive impairment and mild to moderate dementia
Neurology | Geriatrics | Psychiatry |
Nursing | Adult |
Others
NO
Verification of the effectiveness of a psychosocial education support program for people with mild cognitive impairment, dementia, and their family caregivers
Efficacy
Confirmatory
Explanatory
The stress responses: Depression(The Center for Epidemiologic Studies Depression Scale; CES-D)
[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
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
NO
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Educational,Counseling,Training
Behavior,custom | Maneuver |
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.
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.
65 | years-old | <= |
90 | years-old | >= |
Male and Female
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
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
100
1st name | Aya |
Middle name | |
Last name | Seike |
Kyoto University
Kokoro Research Center
606-8511
46, Shimoadachi-cho Kyoto-city, Kyoto, Japan
075-753-9683
seike.aya.6u@kyoto-u.ac.jp
1st name | Keiko |
Middle name | |
Last name | Hara |
National Center for Geriatrics and Gerontology
The Center for Comprehensive Care and Research on Memory Disorders
474-8511
7-430, Morioka-cho Obu-city, Aichi, Japan
0562-87-2515
hendo2@ncgg.go.jp
National Center for Geriatrics and Gerontology
Japan Agency for Medical Research and Development
Japanese Governmental office
1.National Center for Geriatrics and Gerontology,2.Nagoya University,3.Tokyo Medical and Dental University,4.Zenbe Corporation
National Center for Geriatrics and Gerontology
7-430, Morioka-cho Obu-shi, Aichi, Japan
0562-87-2515
ayahime@ncgg.go.jp
NO
国立長寿医療研究センター(愛知県)
2021 | Year | 02 | Month | 16 | Day |
Unpublished
Preinitiation
2020 | Year | 07 | Month | 15 | Day |
2021 | Year | 03 | Month | 01 | Day |
2022 | Year | 07 | Month | 31 | Day |
2021 | Year | 02 | Month | 16 | Day |
2021 | Year | 02 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048422
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