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Construction and Efficacy Evaluation of a Dyadic Personalized Home-Based Activity Intervention Program for Patients Discharged With Mild to Moderate Dementia and Behavioral and Psychological Symptoms

Status: Recruiting
Location: See location...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Union Hospital Affiliated to Fujian Medical University
RECRUITING
Fujian
Contact Information
Primary
Xiaozhen Fu
15160301901@163.com
15160301901
Time Frame
Start Date: 2025-07-20
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 55
Treatments
Experimental: Dyadic personalized home-based activity program intervention
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.
Other: Routine care
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.
Related Therapeutic Areas
Sponsors
Leads: Fujian Medical University

This content was sourced from clinicaltrials.gov