This interventional study aims to evaluate the efficacy of a dyadic personalized home-based activity program in managing behavioral and psychological symptoms of dementia (BPSD) among home-dwelling people living with mild-to-moderate dementia post-discharge. The main question it aims to answer is: Does the dyadic personalized home-based activity program significantly reduce BPSD in individuals post-discharge with mild-to-moderate dementia? Researchers will compare individuals living with mild to moderate dementia who are receiving routine care to see if the dyadic personalized home-based activity program is effective for BPSD. Participants will: 1. In-hospital stage: A personalized home-based activity intervention plan is tailored for patients. Family caregivers receive professional training on care skills related to home-based activities and are provided with corresponding activity resources and support. 2. Post-discharge home-based stage: The intervention is delivered by family caregivers for a total of 12 weeks. The intervention is recommended to be performed twice per week, with each session lasting about 30 minutes in accordance with the patient's individual tolerance. Intermittent rest is advised (e.g., a 2-3 minute break every 10 minutes). The weekly intervention frequency and session duration can be flexibly adjusted according to the family caregivers' schedule and the patient's condition, including mood fluctuations and physical discomfort. Family caregivers are required to record the patient's activity participation, subjective feelings and behavioral responses, and submit regular feedback to the research team. Based on feedback from patients and family caregivers, the research team will conduct dynamic adjustments and continuous optimization of the intervention program throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
55
1. In - hospital stage: A personalized home - based activity intervention program is tailored for patients. Family caregivers receive training on care skills related to home - based activities and are provided with corresponding activity resources and support. 2. Post-discharge home-based stage: The intervention is delivered by family caregivers for a total of 12 weeks.
Participants will receive routine care consisting of standard hospitalization treatment, basic caregiver education on behavioral and psychological symptoms of dementia (BPSD), routine discharge instructions (including general home activity recommendations without personalized intervention assessment, planning or implementation), and routine post-discharge follow-up for 12 weeks.
Union Hospital Affiliated to Fujian Medical University
Fujian, Fuzhou, China
RECRUITINGBehavioral and Psychological Symptoms of Dementia
Assessment using the Neuropsychiatric Inventory (NPI) yields scores ranging from 0 to 144, with higher scores indicating more severe neuropsychiatric symptoms
Time frame: Baseline and post-intervention (at the end of week 12)
Caregiver Distress of Behavioral and Psychological Symptoms of Dementia
Assessment using the caregiver distress section of the Neuropsychiatric Inventory (NPI) yields scores ranging from 0 to 60, with higher scores indicating greater caregiver distress levels
Time frame: Baseline and post-intervention (at the end of week 12)
Cognitive Function of Dementia Patients
Assessment using the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog) yields scores ranging from 0 to 70, with higher scores indicating more severe cognitive impairment
Time frame: Baseline and post-intervention (at the end of week 12)
Activities of Daily Living of Dementia Patients
Assessment using the Activity of Daily Living (ADL) scale yields scores ranging from 20 to 80, with higher scores indicating more severe impairment in daily living activities.
Time frame: Baseline and post-intervention (at the end of week 12)
Apathy of Dementia Patients
Assessment using the Apathy Evaluation Scale-Informant version (AES-I) yields scores ranging from 18 to 72, with higher scores indicating more severe apathy symptoms
Time frame: Baseline and post-intervention (at the end of week 12)
Agitation of Dementia Patients
Assessment using the Cohen-Mansfield Agitation Inventory (CMAI) yields scores ranging from 29 to 203, with higher scores indicating more severe agitated behaviors
Time frame: Baseline and post-intervention (at the end of week 12)
Quality of Life in Dementia
Assessment using the Quality of Life-Alzheimer's Disease (QOL-AD) scale yields total scores ranging from 13 to 52, with higher scores indicating better quality of life
Time frame: Baseline and post-intervention (at the end of week 12)
Caregiver Readiness for Hospital Discharge
Assessment using the Caregiver Preparedness Scale (CPS) yields total scores ranging from 0 to 32, with higher scores indicating better discharge readiness.
Time frame: Baseline(on the day of patient discharge)
Caregiver Burden
Assessment using the Caregiver Burden Inventory (CBI) yields scores ranging from 0 to 88, with a total score of \<21 indicates no or mild burden, 21-39 suggests moderate burden, and ≥40 reflects severe burden.
Time frame: Baseline and post-intervention (at the end of week 12)
Self Efficacy of Caregivers
Assessment using the General Self-Efficacy Scale (GSES) yields scores ranging from 10 to 40, with higher scores indicating greater self-efficacy
Time frame: Baseline and post-intervention (at the end of week 12)
Perceived Social Support of Caregivers
Assessment using the Perceived Social Support Scale (PSSS) yields scores ranging from 12 to 84, with higher scores indicating greater perceived social support
Time frame: Baseline and post-intervention (at the end of week 12)
Depression of Dementia Patients
Assessment using the 24-item Hamilton Depression Scale (HAMD-24) yields total scores ranging from 0 to 78, with higher scores indicating more severe depressive symptoms. Specifically, scores \<8 suggest no depression, 8-20 indicate possible depression, 21-35 confirm clinically significant depression, and \>35 reflect severe depression
Time frame: Baseline and post-intervention (at the end of week 12)
Depression of Caregivers
Assessment using the 24-item Hamilton Depression Scale (HAMD-24) yields total scores ranging from 0 to 78, with higher scores indicating more severe depressive symptoms. Specifically, scores \<8 suggest no depression, 8-20 indicate possible depression, 21-35 confirm clinically significant depression, and \>35 reflect severe depression
Time frame: Baseline and post-intervention (at the end of week 12)
Anxiety of Dementia Patients
Assessment using the Hamilton Anxiety Scale (HAMA) yields total scores ranging from 0 to 56, with ≥29 indicating probable severe anxiety, ≥21 reflecting definite significant anxiety, ≥14 confirming anxiety presence, \>7 suggesting possible anxiety, and \<7 demonstrating no anxiety symptoms.
Time frame: Baseline and post-intervention (at the end of week 12)
Anxiety of Caregivers
Assessment using the Hamilton Anxiety Scale (HAMA) yields total scores ranging from 0 to 56, with ≥29 indicating probable severe anxiety, ≥21 reflecting definite significant anxiety, ≥14 confirming anxiety presence, \>7 suggesting possible anxiety, and \<7 demonstrating no anxiety symptoms.
Time frame: Baseline and post-intervention (at the end of week 12)
Family Quality of Life in Dementia
Assessment using the Family Quality of Life in Dementia Scale (FQOL-D) yields total scores ranging from 13 to 52, with higher scores indicating better family quality of life
Time frame: Baseline and post-intervention (at the end of week 12)
Family Adaptability and Cohesion in Dementia
Assessment was conducted using the Chinese Version of the Family Adaptability and Cohesion Scale, Second Edition (FACES II-CV), which comprises two subscales: Cohesion and Adaptability (15 items each, with subscale scores ranging from 15 to 75; higher scores indicate stronger family cohesion or adaptability
Time frame: Baseline and post-intervention (at the end of week 12)
Number of Participants with Intervention-Related Adverse Events
Time frame: Post-intervention (at the end of week 12)
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