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

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

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 Overview

• Status: Recruiting
• Conditions: Dementia
• Intervention / Treatment: Other: Routine care; Behavioral: Dyadic personalized home-based activity program intervention

• Study Type: Interventional
• Enrollment (Estimated): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaozhen Fu; Phone Number: 15160301901; Email: 15160301901@163.com

Study Locations

• China
  • Fuzhou
    • Fujian, Fuzhou, China
      • Recruiting
      • Union Hospital Affiliated to Fujian Medical University
      • Contact: Xiaozhen Fu; Phone Number: 15160301901; Email: 15160301901@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria Patients

• 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.

Exclusion Criteria Patients

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dyadic personalized home-based activity program intervention; 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.; 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; 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.; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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	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	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	Baseline and post-intervention (at the end of week 12)
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.	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	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	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	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	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.	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.	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	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	Baseline and post-intervention (at the end of week 12)
Number of Participants with Intervention-Related Adverse Events		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.	Baseline（on the day of patient discharge）

Other Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Fujian Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: July 6, 2025
• First Submitted That Met QC Criteria: July 16, 2025
• First Posted (Actual): July 23, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: dementia; home-based; activity; behavioral and psychological symptoms
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Motor Activity; Behavior
• Other Study ID Numbers: FY-EC-2025-304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No