Personalized home activity program for people with mild-to-moderate dementia after hospital 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 will try to see if a tailored home activity program, together with training for family caregivers, reduces agitation and other behavioral symptoms in people aged 60+ with mild-to-moderate dementia after they leave the hospital.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 55 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Fujian Medical University (Academic / other)
• Locations: 1 site (Fujian, Fuzhou)
• Trial ID: NCT07081750 on ClinicalTrials.gov

What this trial studies

Researchers will compare patients receiving routine post-discharge care to those given a dyadic personalized home-based activity program. In the hospital, clinicians tailor an individualized activity plan and train the primary family caregiver while providing activity resources and support. After discharge, the trained caregiver delivers the intervention at home with ongoing professional support and follow-up. The main outcome is change in behavioral and psychological symptoms of dementia measured using standard instruments such as the Neuropsychiatric Inventory.

Who should consider this trial

Good fit: Ideal candidates are home-dwelling adults aged 60 or older with ICD-10 dementia and a Clinical Dementia Rating of 1–2 who have at least one recent neuropsychiatric symptom and a family caregiver willing to be trained and provide home care.

Not a fit: Patients without a reliable, trainable family caregiver, those with severe dementia or lacking basic verbal communication, or those not discharged to home are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the program could reduce behavioral and psychological symptoms, improve daily engagement, and lower caregiver distress to support safer, more comfortable home living.

How similar studies have performed: Caregiver-delivered, home-based activity programs have shown promise in reducing BPSD in prior studies, but dyadic personalized interventions remain moderately tested and need further replication.

Eligibility criteria

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.

Where this trial is running

Fujian, Fuzhou

• Union Hospital Affiliated to Fujian Medical University — Fujian, Fuzhou, China (Recruiting)

Study contacts

• Study coordinator: Xiaozhen Fu

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