The TIME -Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms - for Continuity of Care in Home Care Services
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Affective symptoms measured by the Cornell Scale for Depression in Dementia (CSDD)
研究概览
简要总结
Continuity of care in home care services is necessary to facilitate the assessment and treatment of persons with dementia and cognitive failure. TIME (Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms) is a multi-component intervention with a biopsychosocial approach, based on the theoretical framework of cognitive behavioral therapy and person-centred care. The trial is designed to assess the effects of TIME on Neuropsychiatric symptoms for persons (NPS) with dementia in home care services.
详细描述
The Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms (TIME) is a multi-component intervention with a biopsychosocial approach, based on the theoretical framework of cognitive behavioral therapy and person-centred care. TIME consists of a manual based multicomponent program which includes a rigorous assessment, treatment, and the evaluation of neuropsychiatrc symptoms (NPS).
The cluster RCT will contain two parallel groups, where randomisation is performed based on clusters. One municipality is one cluster, randomized to receive either the intervention with TIME or a brief two hours education-only intervention about dementia and NPS for the control group. Totally 10 municipalities will be included. Data will be collected at baseline before randomisation and at the end of the implementing phase. Measurements at patient level are taken at baseline prior to randomization and after 6 months. The primary outcome measure is difference in change between the intervention group and the control group from baseline to follow up at 6 months in the Cornell Scale for Depression in Dementia (CSDD).
Data collection will be performed by project nurses recruited outside the home care services. They will interview the staff or family members who knows the patient best. The assessors will be blinded to the randomization of the home care services. Interviews will be done by telephone or face-to-face, depending on what is best for the person interviewed.
After the intervention focus group interviews with staff and family members will be conducted.
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 (Participant)
盲法说明
Participants will be masked for the study arm they are randomised to. Staff in the home care service are aware of the study arm their patients are in, while assessors that will interview home care staff by telephone are masked for study randomisation.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dementia, defined as a score of 1 or more on the Clinical Dementia Rating Scale (CDR)
- •A minimum of 15 minutes of home care services per day for the last 4 weeks
- •NPS, defined as a score on the NPI-NH affective subsyndrom (NPI depression + NPI anxiety) of 12 or more
- •Informed consent from the participant or family or next-of-kin
排除标准
- •Terminal disease
结局指标
主要结局
Affective symptoms measured by the Cornell Scale for Depression in Dementia (CSDD)
时间窗: 6 months
The change from baseline of affective symptoms as defined in the Cornell Scale for Depression in Dementia (CSDD), a scale ranging from 0-38 where a higher score indicates more severe depressive symptoms.
次要结局
- NPI-NH: all separate items(6 months)
- Quality of life measured by the scale QUALID(6 months)
- Change in Relatives Stress scale Score (RSS)(6 months)
- Neuropsychiatric Inventory - nursing home version (NPI-NH): Sub syndrome anxiety and depression(6 months)
- NPI-NH: caregiver distress score(6 months)
- Transferring to nursing home(12 months)
- Minimal data set (MDS): patient rejection of care(6 months)