Observational Case Series of Patients With Parkinson's Disease (PD) Attending a Complementary Medicine Neuro-degenerative Disease (NDD) Clinic.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The MDS-sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
研究概览
简要总结
When the charity Homeopathy UK launched a new London based charitable clinic for Neurodegenerative Diseases (NDD), including Parkinson's Disease (PD), it was considered important to document patient's experiences of a high-quality complementary medicine clinic, to enable a greater understanding of the role of complementary medicine for PD.
Routine clinical data, including a couple of questionnaires, is collected from consecutive patients with PD seen in the NDD clinic. Treatments provided are complementary to patients' usual medical treatment, and include homeopathy, herbalism, hypnosis, and healing. Patients may also be provided with self-help advice for lifestyle changes, mindfulness or meditation techniques, and dietary advice, as indicated for complementary therapy management of their condition. Consultations take place approximately every 3 months and patients complete questionnaires at the time of each consultation.
详细描述
Clinical research documenting the effectiveness of complementary medicine for PD is long overdue. Despite high rates of utilization, data on efficacy is generally limited, restricting physicians in providing guidance to interested patients (Bega, 2014).
When the charity Homeopathy UK launched a new London based charitable clinic specifically for NDD, including Parkinson's Disease, it was considered important to document patient's experiences of a high-quality complementary medicine clinic, to enable a greater understanding of the role of complementary medicine for PD.
This is an observational case series with no deviation from routine clinical practice. Routine clinical data is collected from consecutive PD patients seen in the NDD clinic. Patients complete questionnaires regardless of whether they take part in the research. Consultations take place approximately every 3 months (time between appointments may be reduced to 1 month for those patients needing more frequent management, or extended to 6 months for those who require less management). For those patients who are unable to travel, e.g. due to neurological disability and/or long distance away, the 1.5 hour appointment is provided as a remote clinic link using a secure zoom platform.
Treatments provided are complementary, i.e. provided alongside patients' usual medical treatment. Complementary therapies provided include homeopathy, herbalism, hypnosis, and healing. Patients may also be provided with self-help advice for lifestyle changes, mindfulness or meditation techniques, and dietary advice, as indicated for complementary therapy management of their condition.
Two validated outcome measures are used at each clinic visit. Both measures are used both for clinical assessment and the Observational Case Series.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of Parkinson's Disease (self-reported), and Parkinsonism from any causes (patients may have co-existing other health conditions)
排除标准
- •Patients requiring acute medical assessment and management, (as this is beyond the scope of this clinic service) Patients with any other NDD condition Patients without a diagnosis of PD/Parkinsonism. E.g. those at risk of PD such as through a family history (patients in this category may receive treatment at the clinic but are not included in the Observational Case series.
结局指标
主要结局
The MDS-sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
时间窗: At each consultation (approximately every 3 months)
The MDS-UPDRS has four parts: Part I (non-motor experiences of daily living), Part II (motor experiences of daily living), Part III (motor examination) and Part IV (motor complications). The majority of the MDS-UPDRS is completed by the clinic doctor. However Part IB is completed independently by the patient with or without the aid of the caregiver.
Measure Your Own Medical Outcome Profile (MYMOP)
时间窗: At each consultation (approximately every 3 months)
MYMOP is a patient generated outcome measure consisting of 4 self-chosen items measured using a likert type scale of 0 (as good as it could be) to 6 (as bad as it could be): two symptoms considered most bothersome, an activity which the condition limits participation in, and wellbeing. It is a validated, personalized measure allowing patients to select their key concerns, and considered appropriate to capture the non-specific effects of complementary medicine.
次要结局
未报告次要终点
研究者
Philippa Fibert
associate lecturer
St. Mary's University, Twickenham