NCT07081750 · RECRUITING

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

This trial tests whether a structured activity program — designed together with family caregivers before hospital discharge and then carried out at home for 12 weeks — can reduce behavioral and psychological symptoms in people with mild-to-moderate dementia. Think agitation, anxiety, and mood changes. It is a Phase NA randomized study, meaning it is evaluating effectiveness of a behavioral approach, not a drug. Details on the sponsoring institution are limited.

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.

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2026-05-11

View full record on ClinicalTrials.gov

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