Integrated Multidisciplinary Care for Parkinson's Disease: a Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 301
- 试验地点
- 6
- 主要终点
- Parkinson's Disease Quality of Life Questionnaire (PDQL)
研究概览
简要总结
The aim of the present study is to evaluate the (cost) effectiveness of a new health care system in which an individualised multidisciplinary assessment is given to patients with Parkinson's Disease(PD)in combination with treatment by a dedicated team of specifically trained health professionals, compared to usual care. Overall, we anticipate to gain more insight in the clinical effectiveness and health care costs of multidisciplinary treatment in PD.
详细描述
PD is a complex disorder, with motor as well as non-motor symptoms. Despite the complexity of PD, management of the disease is often 'monodisciplinary' since most patients are only treated by a neurologist. Stimulating compensatory strategies by allied health professionals might offer additional therapeutic relief, but this assumption is mainly based on theoretical arguments and expert opinion. Even less is known about the claim that a multidisciplinary team of multiple professionals active in complementary domains (e.g. physiotherapy, occupational therapy and speech therapy) is superior to management by each of these professionals alone.
This study anticipates to provide more insight in the clinical effectiveness and health care costs of multidisciplinary treatment in PD. Therefore, our multidisciplinary care concept (a comprehensive assessment by a dedicated multidisciplinary team and subsequent treatment by specifically trained health professionals) that is tailored to the patients' individual needs will be compared to usual care in terms of effectiveness and costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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 PD, diagnosed according to the Brain Bank Criteria of the UK Parkinson's Disease Society
- •Regular control by the neurologist
- •Living independently in the community
- •Able to complete the trial questionnaires
排除标准
- •Atypical parkinsonian syndromes
- •Hoehn and Yahr stage 5
- •Severe cognitive impairment (MMSE<24)
- •Presence of other neurological disorders
- •Severe co-morbidity (e.g. cancer)
- •Planned surgical procedure for PD within the intervention period
- •Patients who have already visited the Multidisciplinary Assessment Center
结局指标
主要结局
Parkinson's Disease Quality of Life Questionnaire (PDQL)
时间窗: 8 months
AMC Linear Disability Score (ALDS)
时间窗: 8 months
次要结局
- SF-36 (secundary;utility score)(8 months)
- UPDRS Motor Examination (part III)(secondary)(4 months)
- UPDRS Complications of therapy (part IV)(tertiary)(4 months)
- SPDDS(tertiary)(8 months)
- Modified MACTAR scale(tertiary)(8 months)
- Parkinson Activity Scale(tertiary)(4 months)
- Costs (secondary)(8 months)
- Frequency of falls (tertiary)(8 months)
- Freezing of Gait Questionnaire (tertiary)(8 months)
- Falls Efficacy Scale (tertiary)(8 months)
- Non-Motor Symptom Assessment Scale and Quest for Parkinson's Disease (tertiary)(8 months (Quest) and 4 months (Scale))
- Hospital Anxiety and Depression Scale (tertiary)(8 months)
- Caregiver burden assessed with BELA-A-k (secondary), SF-36 (tertiary), and HADS (tertiary)(8 months)