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

NCT07081750 | Not Yet Recruiting DMC

• 1 other identifier: FY-EC-2025-304
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 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. 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.

Conditions

Dementia

Keywords

dementia; behavioral and psychological symptoms; home-based; activity

Outcome Measures

Primary Outcomes (2)

• Behavioral 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

  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

  Baseline and post-intervention (at the end of week 12)

Secondary Outcomes (16)

• Cognitive Function of Dementia Patients

  Baseline and post-intervention (at the end of week 12)

• Activities of Daily Living of Dementia Patients

  Baseline and post-intervention (at the end of week 12)

• Apathy of Dementia Patients

  Baseline and post-intervention (at the end of week 12)

• Agitation of Dementia Patients

  Baseline and post-intervention (at the end of week 12)

• Quality of Life in Dementia

  Baseline and post-intervention (at the end of week 12)

Other Outcomes (3)

• Number of caregivers with varying levels of satisfaction towards the intervention

  Post-intervention (at the end of week 12)

• Number of dementia patients with varying levels of satisfaction towards the intervention

  Post-intervention (at the end of week 12)

• Number of completed activity intervention sessions for dementia patients

  Post-intervention (at the end of week 12)

Study Arms (2)

Dyadic tailored home-based activity program intervention

EXPERIMENTAL

（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.

Behavioral: Dyadic tailored home-based activity program intervention

Routine care

ACTIVE COMPARATOR

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.

Other: Routine care

Interventions

Dyadic tailored home-based activity program intervention BEHAVIORAL

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.

Dyadic tailored home-based activity program intervention

Routine care OTHER

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.

Routine care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Medical University: lead

MeSH Terms

Conditions

Dementia; Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Researcher

Study Record Dates

• First Submitted: July 6, 2025
• First Posted: July 23, 2025
• Study Start: July 20, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share