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

Official title

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

Overview

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.

Interventions

• Behavioral 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.

Primary outcome measures

• Behavioral and Psychological Symptoms of Dementia [Time frame: Baseline and post-intervention (at the end of week 12)]
• Caregiver Distress of Behavioral and Psychological Symptoms of Dementia [Time frame: Baseline and post-intervention (at the end of week 12)]

Secondary outcome measures (12)

• Cognitive Function of Dementia Patients [Time frame: Baseline and post-intervention (at the end of week 12)]
• Activities of Daily Living of Dementia Patients [Time frame: Baseline and post-intervention (at the end of week 12)]
• Apathy of Dementia Patients [Time frame: Baseline and post-intervention (at the end of week 12)]
• Agitation of Dementia Patients [Time frame: Baseline and post-intervention (at the end of week 12)]
• Quality of Life in Dementia [Time frame: Baseline and post-intervention (at the end of week 12)]
• Caregiver Readiness for Hospital Discharge [Time frame: Baseline（on the day of patient discharge）]
• Caregiver Burden [Time frame: Baseline and post-intervention (at the end of week 12)]
• Self Efficacy of Caregivers [Time frame: Baseline and post-intervention (at the end of week 12)]
• Perceived Social Support of Caregivers [Time frame: Baseline and post-intervention (at the end of week 12)]
• Depression of Dementia Patients [Time frame: Baseline and post-intervention (at the end of week 12)]
• Depression of Caregivers [Time frame: Baseline and post-intervention (at the end of week 12)]
• Anxiety of Dementia Patients [Time frame: Baseline and post-intervention (at the end of week 12)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• Union Hospital Affiliated to Fujian Medical University — Fujian

Identifiers

NCT: NCT07081750 · FY-EC-2025-304

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗