Reduction of Falls in the Elderly - Parkinson's Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 187
- 试验地点
- 6
- 主要终点
- Incidence of falls
研究概览
简要总结
The REFINE-PD study is a controlled trial embedded within a larger cluster controlled study (the IMPACT study). The study aims to investigate the efficacy of a multifactorial falls prevention program for patients with Parkinson's Disease (PD). This program contains PD-specific elements (e.g., optimizing dopaminergic therapy), plus a generic falls prevention program. The intervention will be tailored to each individual's specific risk profile for falls, as identified during detailed baseline examination.
详细描述
Falls and postural instability are common complications of advanced Parkinson's Disease (PD). Falls in PD often have devastating consequences, leading to a poor overall prognosis. In addition, falls in PD are associated with substantial medical expenses due to treatment of injuries and nursing home admission. The risk of falls in older PD patients is aggravated by "generic" age-related factors, such as sedative medication or poor vision. Observations on elderly persons without PD suggest that a multifactorial prevention program might be more effective. We propose to investigate the effectiveness of a multifactorial prevention program aimed at the prevention of falls in PD, which is based on disease-specific treatment strategies with demonstrated efficacy in PD, as well as prevention strategies with proven effectiveness for the general elderly population.
In this study an individualised multifactorial program aimed at the prevention of falls in PD containing PD-specific elements and a generic falls prevention program will be compared to usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with idiopathic Parkinson's Disease, diagnosed according to the Brain Bank criteria of the UK Parkinson's Society
- •Regular control by the neurologist
- •Living independently in the community
- •Able to complete the trial questionnaires
- •An increased risk for falling, defined as:
- •at least one fall in the preceding 12 months OR
- •recurrent (monthly) near falls in the preceding 12 months OR
- •fear of falling OR (iv) avoidance of activities due to fear of falling OR a combination of these findings
排除标准
- •Atypical parkinsonian syndromes
- •Hoehn and Yahr stage 5
- •Severe cognitive impairment (MMSE < 24)
- •Severe co-morbidity (e.g., cancer)
- •Planned surgical procedure for PD within the intervention period
- •Patients who have already visited the Multidisciplinary Assessment Center
研究组 & 干预措施
I
Multifactorial fall prevention program
干预措施: Multifactorial fall prevention program (Other)
II
Usual care
干预措施: Usual care (Other)
结局指标
主要结局
Incidence of falls
时间窗: 8 months
次要结局
- Number of fallers (secondary)(8 months)
- Falls Efficacy Scale (tertiary)(8 months)
- Unified Parkinson's Disease rating scale (UPDRS) Motor Examination (part III) (tertiary)(4 months)
- Parkinson's Disease quality of life questionnaire (PDQL) (tertiary)(8 months)
- Self-assessment Parkinson's Disease disability scale (SPDDS)(tertiary)(8 months)
- Caregiver burden assessed with BELA-A-k, SF-36, and HADS (tertiary)(8 months)
- Number of injurious falls (secondary)(8 months)
- Number of patients with injurious falls (secondary)(8 months)
- Freezing of gait (tertiary)(8 months)
- Costs (secondary)(8 months)