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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

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 - Petit-Shoten Study: A pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000048468
Enrollment
10
Registered
2022-07-31
Start date
2021-10-15
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

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 a

Sponsors

Ritsumeikan University
Lead Sponsor
Muko City Office Yoshimoto Kogyo Co National Center for Geriatrics and Gerontology
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, 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.

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 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

Design outcomes

Primary

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

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. 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

Countries

Japan

Contacts

Public ContactAya Seike

RITSUMEIKAN UNIVERSITY SPORT AND HEALTH SCIENCE

seike.aya.w77@kyoto-u.jp077-561-3760

Outcome results

None listed

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