Maintenance of Occupational Therapy for Patients With Alzheimer: A Pragmatic Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 16
- 主要终点
- Neuropsychiatric inventory (NPI) score
研究概览
简要总结
France put a massive effort for improving dementia care through a national Alzheimer plan in 2008 and this effort was confirmed by the next government (Neurodegenerative Diseases Plan 2014-2019). Some new care models and interventions have been implemented such as Alzheimer specialized teams offering occupational therapy. The teams intervene at home with medical prescription. A recent pilot study demonstrated that occupational therapy has the potential to bring clinical benefits for both dementia patients and their caregivers. Nevertheless, occupational therapy has been designed as a short-term intervention and the end of intervention is challenging for therapists and patients. We aim to test the clinical and economic efficacy of maintaining occupational therapy over supplementary 4 months in a pragmatic randomized controlled trial.
详细描述
The Alzheimer specialized teams provide "occupational" therapy to maintain or restore the functional capacities of patients. After a deep evaluation of the expectations and needs of patients and their caregivers, the therapists propose to work one or more specific activities that were once pleasant through 12 to 15 sessions at home over 3 months. They also advise individuals to optimize home safety. A pilot observational study that we conducted reported a significant reduction in behavioral disorders of patients during the first 3 months followed by stability. According to the therapists involved in this study, the 3-month format is considered too short to produce perennial benefits; stimulation is often interrupted at the end of the 3 months, which creates a break in management that can be deleterious for patients.
The main objective of this trial is to evaluate the effectiveness of the maintenance of occupational therapy for 4 months beyond the three months provided for in the regulatory framework for the management of demented patients, Measured by the neuropsychiatric inventory (NPI). The secondary objectives will be to study the efficacy on other clinical criteria but also to carry out an economic evaluation of the maintenance of occupational therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with dementia (regardless of etiology) diagnosed or suspected by their physician (general practitioner or specialist) and referred to an Alzheimer specialized team
- •Patients with Mini Mental State Examination score> 15
- •Patients living at home, in residences for the elderly
- •Presence of a non-professional primary caregiver
排除标准
- •Patients under 18 years of age;
- •Institutionalized or foster care patients;
- •Patients who routinely refuse home care;
- •Patients with a known severe and unstable general pathology that does not allow patient follow-up;
- •Patients already enrolled in another non-drug management trial other than the study;
- •Patients whose institutionalization is probable in the short term (within 6 months) or for whom a change of domicile envisaged in the short term and would not allow the carrying out of the follow-up evaluations;
- •Patients under tutorship or curatorship, patients unable to express consent;
- •Primary caregiver who does not wish to participate in the study or who cannot be available for the follow-up planned for the study;
- •Known cognitive deficits or chronic psychosis that do not able patients' follow-up;
- •Presence of a primary caregiver with known cognitive or psychiatric disorders (chronic active psychosis) , which doesn't allow the proper conduct of the study;
- •Patients who have already benefited from the "occupational" therapy program.
结局指标
主要结局
Neuropsychiatric inventory (NPI) score
时间窗: NPI score will be measured at 7 months
Information on the presence, severity and impact of behavioral disorders. NPI is used to evaluate 12 different types of behavior: delusions, apathy, hallucinations, disinhibition, agitation, irritability, depression, aberrant motor behavior, anxiety, night behavior, euphoria, change in appetite and eating behaviors. This inventory is based on the responses obtained by an informed caregiver, preferably living with the patient. The interview is preferably conducted with the caregiver in the patient's absence, to facilitate open discussion of behaviors that may be difficult to describe in the presence of the patient. If a disorder is present, the caregiver should rate the disorder (1: sometimes, 2: quite often, 3: frequently, 4: very frequently) and the severity of the disorder (1: mild, 2: average ; 3: important). An overall score ranging from 0 to 144 is then calculated, a high score representing greater symptoms in presence, frequency and severity.
次要结局
- Mortality and institutionalization of patients.(at 12 months)
- The care processes.(at 12 months)
- The functional autonomy measured by the Disability Assessment in Dementia (DAD scale).(at 12 months)
- The caregiver burden via the Burden Interview with Zarit(at 12 months)
- The sense of competence of the caregivers(at 12 months)
- The total cost (health and social) of patient care in each of the groups(at 12 months)
- The cost related to the consequences in terms of quality of life of the patient(at 12 months)
- Neuropsychiatric inventory (NPI) score(at 12 months)
- Depression of the patient via the Montgomery-Asberg Depression Rating Scale (MADRS).(at 12 months)
- Apathy of the patient via the Apathy inventory.(at 12 months)
- The cost per disorder behavior avoided(at 12 months)
- Quality of life measured by the Quality of Life in Alzheimer's Disease scale.(at 12 months)
- Patient care consumption measured by the RUD Lite scale(at 12 months)