Occupational Therapy Intervention for Alzheimer's Disease Patients. An International Comparison in Spain and Italy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Barthel
研究概览
简要总结
We followed a pretest-posttest non-equivalent control group experimental design study comparing two cohorts of patient with different types of dementia.
Approximately 250 patients will be screened to achieve 240 participants, divided in two cohorts (120 each), furthermore each cohorts was divided in other two groups (experimental group (60 each) and control group (60 each) the first one followed up by private centres in Spain endowed with Occupational Therapy and the second by public centres in the region of Modena.
详细描述
The course of dementia goes through different stages and during the moderate and advanced stages cognitive decline and functional deterioration are frequently accompanied by the so-called behavioural and psychological symptoms of dementia (BPSD), that put severe stress on the persons with dementia (PwD), on their families and on the health system. Worldwide consensus guidelines recommend non-pharmacological approaches to be first line.
The occupational therapist studies human activity as a therapeutic resource to prevent and treat physical and/or psychosocial difficulties, in order to improve the person's quality of life.
Subjects were not randomly assigned to different treatment groups (control group and experimental group); instead, consecutive sampling was chosen by assigning subjects based on an odd-and-even-numbered technique (odd subjects were assigned to the control group and even subjects to the experimental group). Both groups presented the same pathological, cultural, and sexual characteristics, and belonged to the same age group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Approximately 250 patients will be screened to achieve 240 participants, divided in two cohorts (120 each), furthermore each cohorts was divided in other two groups (experimental group (60 each) and control group (60 each) the first one followed up by private centres in Spain endowed with Occupational Therapy and the second by public centres in the region of Modena
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
- •a diagnosis of primary dementia (DSM V)
- •a MMSE score ≤ 24
- •a NPI global score ≥ 32/144
- •a treatment with significance activities in Occupational Therapy
- •live in a nursing home
排除标准
- •presence of uncontrolled medical disease potentially contributing to the cognitive decline and BPSD
- •concomitant psychiatric disorders or chronic alcoholism
- •concomitant diseases severe enough to reduce life expectancy < 6 months
结局指标
主要结局
Barthel
时间窗: 2 days
\- Evidence suggests that (Barthel Index) BI is a valid measure of activities of daily living; sensitivity to change is limited at extremes of disability (floor and ceiling effects), and reliability of standard BI assessment is acceptable
Tinetti
时间窗: 2 days
\- The Tinetti test has been recommended and widely used in the elderly to assess mobility, balance and gait, and predict falls. Different versions can be found. A systematic literature search identified 37 publications on the Tinetti test and falls.
NPI
时间窗: 2 days
\- The NPI-Q Spanish version offers the possibility to use a reliable and brief instrument that can be used as a screening in the evaluation of neuropsychiatric symptoms in dementia and associated caregiver distress
CDR
时间窗: 2 days
\- The Clinical Dementia Rating (CDR) has demonstrated high validity and reliability for this purpose, but it requires a considerable amount of data to be collected both from the patient and from an informant.
MMSE
时间窗: 2 days
\- The MMSE fulfilled its original goal of providing a brief screening test that quantitatively assesses the severity of cognitive impairment and documents cognitive changes occurring over time
次要结局
未报告次要终点
研究者
OLALLA SAIZ VAZQUEZ
Graduado en Terapia Ocupacional
Universidad de Burgos