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

NCT07081750 | Recruiting DMC

• 1 other identifier: FY-EC-2025-304
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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.

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 personalized home-based activity program intervention

EXPERIMENTAL

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.

Behavioral: Dyadic personalized 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.

Other: Routine care

Interventions

Dyadic personalized home-based activity program intervention BEHAVIORAL

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.

Dyadic personalized 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:

• Be aged ≥ 60 years;
• Have a diagnosis of dementia according to ICD-10 criteria, with a Clinical Dementia Rating (CDR) score of 1-2 (mild-to-moderate stage);
• Retain basic verbal communication ability;
• Present at least one neuropsychiatric symptom (a score ≥ 1 on any single item) within the past month, as evaluated by the Neuropsychiatric Inventory (NPI);
• Be medically fit for hospital discharge and scheduled to receive home care post-discharge;
• Be willing to participate in this study and provide written informed consent.
• Family Caregivers
• Be aged ≥ 18 years;
• Have kinship with the patient (e.g., spouse, children, siblings, etc.);
• Undertake primary care responsibilities on an unpaid, non-professional basis, and have the longest average daily care hours among all family caregivers;
• Be willing to assume continuous home care responsibilities for at least 3 months post-discharge;
• Have intact verbal communication skills;
• Possess basic proficiency in operating the WeChat application (a widely used social communication application in China), including independently sending and receiving messages, as well as making voice and video calls；
• Be willing to participate in this study and provide written informed consent.

You may not qualify if:

• Have severe somatic diseases (e.g., malignant tumors, heart failure, physical disabilities) or severe psychiatric disorders;
• Have severe visual or hearing impairment;
• Have dementia secondary to the following conditions: central nervous system diseases (e.g., encephalitis, brain tumors, epilepsy, multiple sclerosis, Parkinson's disease), nutritional and metabolic disorders (e.g., thyroid dysfunction, vitamin B12 or folate deficiency), substance or alcohol dependence, and other potential causes of secondary dementia;
• Suffer from severe physical or mental disorders, extreme debilitation, long-term bedridden status, end-stage disease with a life expectancy of less than six months, or be unable to cooperate with or tolerate the study intervention;
• Be enrolled in any other clinical research that may interfere with the outcomes of this study.
• Family Caregivers
• Have severe somatic diseases (e.g., malignant tumors, heart failure, physical disabilities) or severe psychiatric disorders;
• Have severe visual or hearing impairment;
• Be enrolled in any other clinical research that may interfere with the outcomes of this study.

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Union Hospital Affiliated to Fujian Medical University

Fujian, Fuzhou, China

RECRUITING

MeSH Terms

Conditions

Dementia; Behavior; Motor Activity

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Xiaozhen Fu

CONTACT

15160301901; 15160301901@163.com

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: June 30, 2026
• Study Completion: June 30, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)