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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Caregiver Distress of Behavioral and Psychological Symptoms of Dementia
研究概览
简要总结
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:
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Routine care (Other)
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.
干预措施: Dyadic personalized home-based activity program intervention (Behavioral)
结局指标
主要结局
Caregiver Distress of Behavioral and Psychological Symptoms of Dementia
时间窗: 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
Behavioral and Psychological Symptoms of Dementia
时间窗: 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
次要结局
- Self Efficacy of Caregivers(Baseline and post-intervention (at the end of week 12))
- Family Quality of Life in Dementia(Baseline and post-intervention (at the end of week 12))
- Family Adaptability and Cohesion in Dementia(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))
- Cognitive Function of Dementia Patients(Baseline and post-intervention (at the end of week 12))
- Apathy of Dementia Patients(Baseline and post-intervention (at the end of week 12))
- Anxiety of Dementia Patients(Baseline and post-intervention (at the end of week 12))
- Anxiety of Caregivers(Baseline and post-intervention (at the end of week 12))
- Agitation of Dementia Patients(Baseline and post-intervention (at the end of week 12))
- Quality of Life in Dementia(Baseline and post-intervention (at the end of week 12))
- Depression of Dementia Patients(Baseline and post-intervention (at the end of week 12))
- Depression of Caregivers(Baseline and post-intervention (at the end of week 12))
- Activities of Daily Living of Dementia Patients(Baseline and post-intervention (at the end of week 12))
- Caregiver Burden(Baseline and post-intervention (at the end of week 12))
- Perceived Social Support of Caregivers(Baseline and post-intervention (at the end of week 12))
- Caregiver Readiness for Hospital Discharge(Baseline（on the day of patient discharge）)
研究者
Xiaozhen Fu
Graduate Researcher
Fujian Medical University