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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000043337
Enrollment
100
Registered
2021-02-16
Start date
2021-03-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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
First Steps (Classroom Textbooks for People with Dementia and Family Caregivers)&quot
and &quot
For Family Caregivers Supporting People with Dementia&quot
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.

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
[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

Countries

Japan

Contacts

Public ContactKeiko Hara

National Center for Geriatrics and Gerontology The Center for Comprehensive Care and Research on Memory Disorders

hendo2@ncgg.go.jp0562-87-2515

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026