Dementia
Conditions
Keywords
dementia, behavioral and psychological symptoms, home-based, activity
Brief 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.
Interventions
BEHAVIORALDyadic 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.
OTHERRoutine 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.
Sponsors
Fujian Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Behavioral and Psychological Symptoms of Dementia | Baseline and post-intervention (at the end of week 12) | Assessment using the Neuropsychiatric Inventory (NPI) yields scores ranging from 0 to 144, with higher scores indicating more severe neuropsychiatric symptoms |
| Caregiver Distress of Behavioral and Psychological Symptoms of Dementia | Baseline and post-intervention (at the end of week 12) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Function of Dementia Patients | Baseline and post-intervention (at the end of week 12) | 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 |
| Activities of Daily Living of Dementia Patients | Baseline and post-intervention (at the end of week 12) | 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. |
| Apathy of Dementia Patients | Baseline and post-intervention (at the end of week 12) | 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 |
| Agitation of Dementia Patients | Baseline and post-intervention (at the end of week 12) | Assessment using the Cohen-Mansfield Agitation Inventory (CMAI) yields scores ranging from 29 to 203, with higher scores indicating more severe agitated behaviors |
| Quality of Life in Dementia | Baseline and post-intervention (at the end of week 12) | 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 |
| Caregiver Readiness for Hospital Discharge | Baseline（on the day of patient discharge） | Assessment using the Caregiver Preparedness Scale (CPS) yields total scores ranging from 0 to 32, with higher scores indicating better discharge readiness. |
| Caregiver Burden | Baseline and post-intervention (at the end of week 12) | 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. |
| Self Efficacy of Caregivers | Baseline and post-intervention (at the end of week 12) | Assessment using the General Self-Efficacy Scale (GSES) yields scores ranging from 10 to 40, with higher scores indicating greater self-efficacy |
| Perceived Social Support of Caregivers | Baseline and post-intervention (at the end of week 12) | Assessment using the Perceived Social Support Scale (PSSS) yields scores ranging from 12 to 84, with higher scores indicating greater perceived social support |
| Depression of Dementia Patients | Baseline and post-intervention (at the end of week 12) | 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 |
| Depression of Caregivers | Baseline and post-intervention (at the end of week 12) | 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 |
| Anxiety of Dementia Patients | Baseline and post-intervention (at the end of week 12) | 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. |
| Anxiety of Caregivers | Baseline and post-intervention (at the end of week 12) | 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. |
| Family Quality of Life in Dementia | Baseline and post-intervention (at the end of week 12) | 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 |
| Family Adaptability and Cohesion in Dementia | Baseline and post-intervention (at the end of week 12) | 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 |
| Number of Participants with Intervention-Related Adverse Events | Post-intervention (at the end of week 12) | — |
Countries
China
Contacts
CONTACTXiaozhen Fu
Outcome results
None listed