Dyadic Tailored Home-Based Activity Program for Mild-to-Moderate Dementia Patients Post-Discharge

Fujian Medical University

Status: Not yet enrolling

Conditions: Dementia

Treatments: Other: Routine care; Behavioral: Dyadic tailored home-based activity program intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07081750

FY-EC-2025-304

Details and patient eligibility

About

This interventional study aims to evaluate the efficacy of a dyadic tailored 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 tailored home-based activity program significantly reduce BPSD in individuals with mild-to-moderate dementia after hospital discharge?

Researchers will compare people living with mild to moderate dementia who are receiving routine care to see if the dyadic tailored home-based activity program is effective for BPSD.

Participants will:

1. During hospitalization: People living with mild to moderate dementia and their caregivers receive health education on managing behavioral and psychological symptoms of dementia (BPSD); Participating activity sessions to assess individual preferences and functional activity capabilities, followed by co-designing a dyadic tailored home-based activity program.
2. After discharge: People living with mild to moderate dementia and their caregivers jointly receive a 12-week dyadic tailored home-based activity intervention at home.

Enrollment: 55 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients:

• Aged ≥60 years;
• ICD-10 diagnosed dementia with Clinician's Dementia Rating (CDR) scores of 1-2 (mild-to-moderate stage);
• Preserved basic verbal communication capacity;
• Exhibit at least one neuropsychiatric symptom (score ≥1 on any item) in the past month, as assessed by the Neuropsychiatric Inventory (NPI);
• Medically cleared for discharge with planned home-based care;
• Willing to provide written informed consent.

Caregivers:

• Aged ≥18 years;
• Designated primary caregiver (the individual spends the longest time caring for the patient each day);
• Committed to maintaining home caregiving responsibilities for at least 3 months post-discharge;
• Intact verbal communication skills;
• Possess basic operational proficiency with the WeChat application (capable of independently sending/receiving messages and conducting voice/video calls)
• Willing to provide written informed consent.

Exclusion criteria

Patients:

• Comorbid severe somatic diseases (e.g., malignant tumors, heart failure, physical disabilities) or psychiatric disorders;
• Severe visual or hearing impairment;
• Dementia caused by the following conditions: Central nervous system diseases (e.g., encephalitis, brain tumors, epilepsy, multiple sclerosis, Parkinson's disease); Nutritional/metabolic disorders (e.g., thyroid dysfunction, vitamin B12/folate deficiency); Substance or alcohol dependence; Other potential etiologies of secondary dementia;
• Severe physical or mental illness, extreme debilitation, long-term bedridden status, end-stage disease (with a life expectancy of less than six months), or an inability to cooperate with or tolerate the study;
• Currently participating in other medical research that may interfere with study outcomes.

Caregivers:

• Comorbid severe somatic diseases (e.g., malignant tumors, heart failure, physical disabilities) or psychiatric disorders;
• Severe visual or hearing impairment;
• Currently participating in other medical research that may interfere with study outcomes.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

55 participants in 2 patient groups

Dyadic tailored home-based activity program intervention

Experimental group

Description:

（1） During hospitalization, caregivers receive health education on managing behavioral and psychological symptoms of dementia. Patient-caregiver dyads participate in structured ward activities to assess activity preferences and capabilities, forming the basis for co-developing individualized home activity plans with training for caregivers. （2） A customized home activity kit is provided at discharge. （3） Post-discharge, a 12-week tailored home intervention is implemented, using a patient-centered model with caregiver support. Caregivers record participation and behavioral responses, which inform dynamic adjustments to activity content, difficulty, and methods.

Treatment:

Behavioral: Dyadic tailored home-based activity program intervention

Routine care

Active Comparator group

Description:

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.

Treatment:

Other: Routine care