Multicomponent Intervention in Caregivers on Quality of Life of People With Dementia: a Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Changes in quality of life of the patients after intervention and 6 months follow-up in control and intervention group: Quality of Life-Alzheimer's Disease (QoL-AD)
研究概览
简要总结
The main objective is to determine the effectiveness of a multicomponent intervention for caregivers, conducted by an expert psychologist to improve the quality of life of the people with Alzheimer's disease. Secondarily, will be analyzed the effectiveness of this program on improving anxiety and depressive symptoms, burden, happiness, social support and cognitive performance of the caregivers and alleviate the behavioural and psychological symptoms of dementia (BPSD). The investigators analyze the caregiver's and patient's personality as a possible moderator between dependent and independent variables, and the resources utilization before and after intervention.
Methods: randomized study with parallel assignment in two groups: control and intervention group, six-month follow-up. The eligible participants will be 94 adult (≥18 years) caregivers of patients with Alzheimer's disease who follow-up by Osona Integrated Geriatric Unite (Catalonia, Spain).
The intervention group will receive a multicomponent intervention that includes dementia psychoeducation and management, emotional and communication skills, mindfulness and healthy lifestyle. The control group will follow the standard management according to the primary and specialized care professionals' team.
Main measurements: quality of life of the patients at baseline, after intervention and at six-month follow-up through QoL-AD. Secondary measures: they will be determined, at baseline, after the intervention and at six-month follow-up: depression (HDRS) and anxiety (HARS), burden (CBI), happiness (OHQ), quality of life (QoL-AD), social support (UCLA and DUKE-ANC), cognitive performance (neuropsychological assessment) of the caregivers, resources utilization (RUD), BPSD (NPI), cognitive status (MMSE), functional status (IADL) of the patients. Caregiver's personality at baseline and six-month follow-up and dementia characteristics at baseline will be measured. Other measures: sociodemographic and health characteristics of the caregivers and patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults (≥18 years of age)
- •main caregivers of people with early or mild Alzheimer's disease
- •follow-up by Osona Integrated Geriatric Unite (Catalonia)
- •signed informed consent.
排除标准
- •non stable medical condition the last six months (or any acute or chronic condition that would limit the ability of the patient to participate in the study)
- •cognitive impairment (MMSE<24)
- •substance abuse
- •active psychotherapy
- •refusal to give informed consent
结局指标
主要结局
Changes in quality of life of the patients after intervention and 6 months follow-up in control and intervention group: Quality of Life-Alzheimer's Disease (QoL-AD)
时间窗: Baseline, immediately after the intervention and 6 month follow-up
Quality of life assessed using Quality of Life-Alzheimer's Disease (QoL-AD). The total score ranges from 13 to 52, with a higher number indicating better quality of life
次要结局
- Satisfaction with the intervention: Interview(Immediately after the intervention)
- Changes in quality of life of the caregivers: Quality of Life-Alzheimer's Disease (QoL-AD)(Baseline, immediately after the intervention and 6 month follow-up)
- Changes in loneliness(Baseline, immediately after the intervention and 6 month follow-up)
- Characteristics and changes in caregivers personality(Baseline, immediately after the intervention and 6 month follow-up)
- Changes in Behavioural and Psychological Symptoms of Dementia(Baseline, immediately after the intervention and 6 month follow-up)
- Burden in caregivers(Baseline, immediately after the intervention and 6 month follow-up)
- Changes in depression of the caregivers(Baseline, immediately after the intervention and 6 month follow-up)
- Changes in cognitive performance of the caregivers(Baseline, immediately after the intervention and 6 month follow-up)
- Changes in sleep patterns of the caregivers(Baseline, immediately after the intervention and 6 month follow-up)
- Changes of the resource utilization(Baseline, immediately after the intervention and 6 month follow-up)
- Changes in cognitive status of the patients(Baseline, immediately after the intervention and 6 month follow-up)
- Anxiety(Baseline, immediately after the intervention and 6 month follow-up)
- Happiness(Baseline, immediately after the intervention and 6 month follow-up)
- Changes in perceived social support of the caregivers(Baseline, immediately after the intervention and 6 month follow-up)
- Functional status of the patients(Baseline, immediately after the intervention and 6 month follow-up)
研究者
Dr. Pere Roura-Poch
Head of Epidemiology
Consorci Hospitalari de Vic