The Value of Virtual Education on Deep Brain Stimulation for Surgical Candidates
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Parkinson Anxiety Scale (PAS)
研究概览
简要总结
The success of Deep Brain Stimulation (DBS) is more correlated to fulfillment of patients' expectations, than merely improvement of motor status1. Therefore, it is of utmost importance to inform the DBS candidates as good as possible to set realistic expectations. Currently, the patient - most of the time accompanied by a family member - is informed about the surgery and its benefits and risks during the outpatient consultation of the neurologist, and later on during the consultation of the neurosurgeon. Written information is provided in the form of a booklet that the patients take home.
Due to the large amount of information, not all of it can be captured by the patient. Therefore, we would like to investigate whether an additional online immersive educational session on DBS would better educate the patient. The online session is a 1-hour video call with a small group of DBS candidates and their caregivers, lead by DBS experts, where testimonials of other patients are shown, together with multiple infographics. Two weeks later their will be a second online session summarizing the information and providing the opportunity for Q&A.
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
- None
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
- •Patients of any age over 18 who are capable of understanding and granting informed consent.
- •Consecutive enrollment of Parkinson's disease patients, eligible for DBS surgery who will be operated in Toronto Western Hospital.
- •Targets of surgery (STN or GPi) equally in each study arm.
- •Patients must be able to follow the assessment procedure.
排除标准
- •1. people with limited digital skills (to the discretion of the PI).
研究组 & 干预措施
Educational Group
Patients will receive two extra virtual educational sessions.
干预措施: Educational Sessions (Other)
Standard-of-Care
Patients will not receive any extra educational sessions. Their education will be provided as per standard-of-care by the clinical team.
结局指标
主要结局
Parkinson Anxiety Scale (PAS)
时间窗: Baseline, 3 months post op
is a 12-item observer or patient-rated scale with three subscales, for persistent and episodic anxiety, and avoidance behaviour. The total score on the PAS can range from 0 to 48. Higher scores indicate greater experiences of anxiety
The Beck Depression Inventory (BDI)
时间窗: Baseline, 3 months post op
Is a 21-items questionnaire that is filled out by the patient to self-rate mood-related statements. The total score can range from 0 to 63. Higher scores indicate greater severity of depressive symptoms.
The Parkinson's Disease Questionnaire (PDQ-39)
时间窗: Baseline, 3 months post op
This questionnaire assesses how often people with Parkinson's experience difficulties. across 8 dimensions of daily living. The total score for each dimension ranges from 0 (never have difficulty) to 100 (always have difficulty). Lower scores indicate better quality of life.
Structured survey
时间窗: Baseline, one day before surgery, 3 months post op
Assesses the level of knowledge (score range: 0-110), anxiety (score range: 0-100), expectation (score range: 0-100), satisfaction (score range: 0-80).
MDS-UPDRS (Movement Disorders Society Unified Parkinson's Disease Rating Scale)
时间窗: Baseline, 3 months post op
Is composed of 4 parts4. Part 1 in on the non-motor aspects of experiences of daily living, with the first half begin rated by the health care professional, based on input from the patient and the caregiver; and the second half a patient questionnaire. Part 2 is on the motor aspects of experiences of daily living, which is a questionnaire filled out by the patient and the caregiver. In the 3rd part the motor condition of the patient evaluated by the physician or nurse practitioner, in meds-ON and DBS-ON condition. The fourth and final part evaluates the motor complications and is rated by the health care professional, based on input from the patient and the caregiver. The total score on the MDS-UPDRS ranges from 0 to 260. The score indicates: 0: No disability 260: Total disability.
次要结局
未报告次要终点
研究者
Alfonso Fasano
Professor, Department of Medicine, Division of Neurology at University of Toronto, Toronto Western Hospital
University of Toronto