PD-DigiCare: Enhancing Referral Decision-making for Advanced Treatment in Parkinson's Disease Through Objective Measurements and Patient Reported Outcomes - a Multicentre Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- Differences between groups in algorithm-based motor symptom burden (time spent in the ON state without dyskinesias) at referral to evaluation for advanced treatment.
研究概览
简要总结
The overall aim of the trial is to compare the efficacy of using wearables and patient-reported outcome measures versus standard care in enhancing the timeliness of referrals to advanced monitoring of treatments for people with Parkinson's Disease.
详细描述
The study is a multicentre, parallel group, randomized controlled trial, investigating the value of using wearable devices and electronic patient-reported outcome measurements to improve clinical decision-making related to people with Parkinson's Disease.
Data from a wearable device and a mobile app will be compared to current standard of care.
90 participants will be recruited from the uptake area of the Movement Disorder Clinics (MDC) at Rigshospitalet Glostrup (RHG) and Odense University Hospital (OUH), as well as from 5 private practice neurologists in Denmark. They will equally be randomized to one of two groups: Intervention or Standard of Care.
Each participant will take part of the trial for one year, in which they will have 5 study visits:
- Baseline
- Clinical visits every 3 months (months 3, 6 and 9)
- Final visit after 12 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Participants and physicians will be blinded to device and app data in the control group. Blinding of the group allocation is not possible due to the investigated device.
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
- •Diagnosed with Idiopathic Parkinson's Disease
- •Taking five or more doses of levodopa daily
- •Experiencing fluctuations in motor function with regards to OFF time and/or dyskinesia.
- •Able to utilize a digital product, either alone or assisted by a caregiver.
排除标准
- •Consistent use of a wheelchair or walker which may interfere significantly with the remote monitoring of PD motor symptoms.
- •Lack of understanding and proficiency in the Danish language.
- •Inability to use wearable devices due to non-compliance, physical and/or skin sensitivity.
- •Suffering from severe psychiatric disorders.
- •Otherwise not qualified to receive advanced treatment (e.g., advanced cancer, severe heart failure).
- •Already undergoing advanced treatment.
- •Diagnosed with atypical or secondary parkinsonism.
- •Other patient groups otherwise deemed ineligible by the project manager.
结局指标
主要结局
Differences between groups in algorithm-based motor symptom burden (time spent in the ON state without dyskinesias) at referral to evaluation for advanced treatment.
时间窗: 1 year
Time spent in the ON state without dyskinesias, as measured by the Neptune algorithm
次要结局
- Changes in type of, frequency and dose of medication (calculated Levodopa Equivalent Dose, LED, by use of Tomlinson's scale)(1 year)
- Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention.(1 year)
研究者
Bo Biering-Soerensen
MD, MPG, associate professor
Rigshospitalet, Denmark