Efficacy of psychosocial education support programs for people with mild cognitive impairment, dementia, and their family caregivers: Randomized controlled trials

UMIN ID: UMIN000043337

Registered date:16/02/2021

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: 1. Mild cognitive impairment, mild to moderate dementia 2. Family caregivers of people with mild cognitive impairment and mild to moderate dementia
• Date of first enrollment: 2021/03/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

• Primary Outcome: The stress responses: Depression(The Center for Epidemiologic Studies Depression Scale; CES-D)
• Secondary Outcome: [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

Key inclusion & exclusion criteria

• Age minimum: 65years-old
• Age maximum: 90years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: National Center for Geriatrics and Gerontology
• Secondary Sponsor: 1.National Center for Geriatrics and Gerontology,2.Nagoya University,3.Tokyo Medical and Dental University,4.Zenbe Corporation
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development