Tele-health Outcomes as Digital Biomarkers of Parkinson's Disease Progression During Extended Follow up of STEADY-PD3 and SURE-PD3 Trial Participants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- Change in Smartphone Tapping (Score)
研究概览
简要总结
An observational study to characterize and compare long-term clinical outcomes data collected remotely through periodic tele-visits, interactive smartphone app sessions, and web-based surveys in individuals with Parkinson's Disease (PD) who have completed the interventional phases of the STEADY-PD3 and SURE-PD3 clinical trials.
详细描述
Telemedicine and smartphone-based remote sensor assessments represent particularly promising opportunities to streamline study conduct, reduce participant burden, and allow for the collection of data beyond the usual episodic, in-clinic assessments. Demonstrating the utility of these relatively inexpensive accessible platforms for the measurement of PD progression would also establish the infrastructure for long-term follow up of participants after completion of interventional studies.
STEADY-PD3 (a.k.a. STEADY-PD III) and SURE-PD3 were both designed as phase 3 trials of potential disease-modifying interventions in PD. In both studies, de novo PD participants were randomized in 1:1 allocation to active therapy versus placebo with longitudinal follow up for three and two years, respectively. Both studies include collection of DNA and plasma samples, which along with rigorously collected clinical data will become part of the Parkinson's Disease Biomarker Program (PDBP), providing valuable resources for biomarker development. Long-term observation of participants from these two trials, together comprising ~600 early PD subjects, is invaluable not only in characterizing any persistent or delayed benefits of either randomized treatment but also in the development of tele-health outcomes to facilitate future interventional trials in PD and of neurotherapeutics more broadly.
Challenges of traditional long-term follow up of large cohorts are the high cost of in-clinic assessment, the high dropout rates and the need to maintain multi-site infrastructure. The objective of this study is to leverage modern technology to develop, pilot and implement a 100% virtual model for long-term follow up utilizing telemedicine and smartphone platforms for quantitative monitoring of clinician- and patient-reported outcomes (PROs). This cohort may also serve to test feasibility of new technology platforms as they become available.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrollment in STEADY-PD3 or SURE-PD3 studies
- •Prior consent to be contacted by the University of Rochester (UR) or if a participant from STEADY-PD III or SURE-PD3 studies directly contacts UR to request information about study participation
- •Internet-enabled device that will support participation in tele-visits
- •Have created or willing to create a Global Unique Identifier (GUID)
- •Willing and able to provide informed consent
- •English fluency
- •For participants opting to participate in the smartphone component, possession of a suitable smartphone (iPhone or Android) with adequate data plan and cellular network access/signal or wifi access
排除标准
- •Inability to carry out study activities as determined by study staff
结局指标
主要结局
Change in Smartphone Tapping (Score)
时间窗: Two years (0, 3, 6, 9, 12 , 15, 18, 21, and 24 months)
The Smartphone Tapping Score is derived from a 30-second finger tapping task performed separately for each hand. The score ranges from 0 to 1 and higher scores are worse.
Change in Tele-visit MDS-UPDRS Part 2 (Score)
时间窗: Two years (0, 12, and 24 months)
The Movement Disorders Society Unified PD Rating Scale (MDS-UPDRS) Part II score comprises patient-reported responses to 13 questions on motor experiences of daily living. The response to each question is assessed on a 5-point Likert scale ranging from 0 to 4 where higher scores imply worse symptoms. Part II scores may range from a minimum of 0 to a maximum of 52, with higher values meaning worse symptoms.
Change in Tele-visit Modified MDS-UPDRS Parts 1-3 (Total Score)
时间窗: Two years (0, 12, and 24 months)
Participants will be asked to complete (from home or other preferred environment) an hour-long Tele-visit that includes the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS), comprising MDS-UPDRS part 1a and (modified) part 3, as well as completion or confirmation of patient-reported component parts 1b and 2. The MDS-UPDRS is assessed on a 5-point Likert scale ranging from 0 to 4 where higher scores imply worse features. Parts I-III contain 59 total questions (13 in Part I, 13 in Part II, and 33 in Part III). Total scores are calculated as simple sums of component items with mean imputation by Part if no more than 1, 2, or 7 items are missing for Parts I through III, respectively. Total scores may range from 0 to 236, with 0 meaning no symptoms and 236 meaning worse symptoms.
Change in Fox Insight MDS-UPDRS Part 2 (Score)
时间窗: Two years (0, 6, 12, 18, and 24 months)
The Fox Insight MDS-UPDRS (Movement Disorders Society Unified PD Rating Scale) Part II score comprises patient-reported responses to 13 questions on motor experiences of daily living. Participants report their responses online through the Fox Insight web-based platform. The response to each question is assessed on a 5-point Likert scale ranging from 0 to 4 where higher scores imply worse symptoms. Part II scores may range from a minimum of 0 to a maximum of 52, with higher values meaning worse symptoms.
次要结局
- Change in Fox Insight Geriatric Depression Scale (GDS; Score)(Two years (0, 12, and 24 months))
- Change in Tele-visit Modified MDS-UPDRS Part 3 (Score)(Two years (0, 12, and 24 months))
- Change in Fox Insight Parkinson's Disease Questionnaire - 8 Item Version (PDQ-8; Score)(Two years (0, 3, 6, 9, 12, 15, 18, 21, and 24 months))
- Change in Tele-visit Montreal Cognitive Assessment (MoCA; Score)(Two years (0, 12, and 24 months))
- Change in Tele-visit Schwab and England (S&E; Score)(Two years (0, 12, and 24 months))
- Change in Tele-visit Clinician Global Impression - Severity (CGIS; Score)(Two years (0, 12, and 24 months))
- Change in Fox Insight REM (Rapid Eye Movement) Behavior Disorder (RBD; Score)(Two years (0, 3, 6, 9, 12, 15, 18, 21, and 24 months))
- Change in Fox Insight Parkinson's Daily Activities Questionnaire -15 (PDAQ-15; Score)(Two years (0, 3, 9, 15, and 21 months))
- Change in Tele-visit MDS-UPDRS Part 1a (Score)(Two years (0, 12, and 24 months))
- Change in Tele-visit MDS-UPDRS Part 1b (Score)(Two years (0, 12, and 24 months))
- Change in Fox Insight EuroQol Five Dimensions Questionnaire (EQ-5D; Score)(Two years (0, 6, 12, 18, and 24 months))
- Change in Fox Insight Non-motor Symptoms Questionnaire (NMS-QUEST; Score)(Two years (0, 3, 6, 9, 12, 15, 18, 21, and 24 months))
研究者
Michael Alan Schwarzschild
Professor of Neurology
Massachusetts General Hospital