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Assessing Tele-Health Outcomes in Multiyear Extensions of PD Trials (AT-HOME PD)

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ClinicalTrials.gov Identifier: NCT03538262
Recruitment Status : Recruiting
First Posted : May 28, 2018
Last Update Posted : April 24, 2019
Sponsor:
Collaborators:
Northwestern University
Sage Bionetworks
University of Rochester
National Institute of Neurological Disorders and Stroke (NINDS)
Michael J. Fox Foundation for Parkinson's Research
The Parkinson Study Group
Information provided by (Responsible Party):
Michael Alan Schwarzschild, Massachusetts General Hospital

Tracking Information
First Submitted Date April 16, 2018
First Posted Date May 28, 2018
Last Update Posted Date April 24, 2019
Actual Study Start Date October 1, 2018
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 15, 2018)
  • Tele-visit modified MDS-UPDRS parts 1-3 (total score) [ Time Frame: Baseline (0 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.
  • Change in Tele-visit modified MDS-UPDRS parts 1-3 (total score) [ Time Frame: 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.
  • Change in Tele-visit MDS-UPDRS part 2 (score) [ Time Frame: 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 completion or confirmation of part 2 of the MDS-UPDRS.
  • Change in Smartphone tapping (score) [ Time Frame: Two years (0, 3, 6, 9, 12 , 15, 18, 21, and 24 months) ]
    Participants will undergo a series of 10 tapping assessments every three months using a smartphone app.
  • Change in Fox Insight MDS-UPDRS part 2 (score) [ Time Frame: Two years (0, 6, 12, 18, and 24 months) ]
    Participants will be asked to complete a set of standard questionnaires every 3 months through a companion study called Fox Insight. This online observational study, conducted by The Michael J. Fox Foundation, seeks to better understand experiences of daily living in PD and how they change with disease progression. The MDS-UPDRS (part 2) questionnaire is completed every 6 months (at every other Fox Insight survey set).
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03538262 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 15, 2018)
  • Tele-visit MDS-UPDRS part 1a (score) [ Time Frame: Two years (0, 12, and 24 months) ]
  • Tele-visit MDS-UPDRS part 1b (score) [ Time Frame: Two years (0, 12, and 24 months) ]
  • Tele-visit Modified MDS-UPDRS part 3 (score) [ Time Frame: Two years (0, 12, and 24 months) ]
  • Tele-visit Montreal Cognitive Assessment (MoCA; score) [ Time Frame: Two years (0, 12, and 24 months) ]
  • Tele-visit Schwab and England (S&E; score) [ Time Frame: Two years (0, 12, and 24 months) ]
  • Tele-visit Clinician Global Impression (CGI; score) [ Time Frame: Two years (0, 12, and 24 months) ]
  • Smartphone cognitive assessment (score) [ Time Frame: Two years (0, 3, 6, 9, 12, 15, 18, 21, and 24 months) ]
  • Fox Insight Parkinson's Disease Questionnaire - 8 item version (PDQ-8; score) [ Time Frame: Two years (0, 3, 6, 9, 12, 15, 18, 21, and 24 months) ]
  • Fox Insight EuroQol Five Dimensions Questionnaire (EQ-5D; score) [ Time Frame: Two years (0, 6, 12, 18, and 24 months) ]
  • Fox Insight Non-motor Symptoms Questionnaire (NMS-QUEST; score) [ Time Frame: Two years (0, 3, 6, 9, 12, 15, 18, 21, and 24 months) ]
  • Fox Insight REM (Rapid Eye Movement) Behavior Disorder (RBD; score) [ Time Frame: Two years (0, 3, and 15 months) ]
  • Fox Insight Parkinson's Daily Activities Questionnaire -15 (PDAQ-15; score) [ Time Frame: Two years (0, 3, 9, 15, and 21 months) ]
  • Fox Insight Geriatric Depression Scale (GDS; score) [ Time Frame: Two years (0, 12, and 24 months) ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessing Tele-Health Outcomes in Multiyear Extensions of PD Trials
Official Title Tele-health Outcomes as Digital Biomarkers of Parkinson's Disease Progression During Extended Follow up of STEADY-PD3 and SURE-PD3 Trial Participants
Brief Summary 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.
Detailed Description

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All individuals with early idiopathic PD enrolled in the STEADY-PD3 (a.k.a. STEADY-PD III; NCT02168842) and SURE-PD3 (NCT02642393) studies.
Condition Parkinson Disease
Intervention Not Provided
Study Groups/Cohorts former phase 3 PD trial participants
The AT-HOME PD cohort enrolled upon completion of STEADY-PD3 or during completion of SURE-PD3; enrolling 2 to 6 years after diagnosis, and on standard dopaminergic therapy for 0 to 3 years. Former STEADY-PD3 participants had been randomized (1:1) to 3 years of isradipine or placebo treatment; SURE-PD3 participants had been randomized (1:1) to 2 years of inosine or placebo treatment.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 15, 2018)
420
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 31, 2023
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Enrollment in STEADY-PD3 or SURE-PD3 studies
  2. 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
  3. Internet-enabled device that will support participation in tele-visits
  4. Have created or willing to create a Global Unique Identifier (GUID)
  5. Willing and able to provide informed consent
  6. English fluency
  7. 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

Exclusion Criteria:

1. Inability to carry out study activities as determined by study staff

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Not Provided
Contacts
Contact: AT-HOME PD Hotline Number 508-233-2473 ext 1 help@athomepd.org
Contact: Katherine F Callahan 617-726-5714 kfcallahan@mgh.harvard.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03538262
Other Study ID Numbers AHPD-U01NS107009
U01NS090259-01A1 ( U.S. NIH Grant/Contract )
U01NS080818-01A1 ( U.S. NIH Grant/Contract )
U01NS080840-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Data will be collected across individual sites (University of Rochester for tele-visit data; Sage Bionetworks for smartphone data; MJFF-sponsored portal in the Laboratory of Neuroimaging (LONI) for FI PRO data). Data from all three sites will be aggregated in a centralized location using Synapse. Synapse is a cloud-based scientific data management and research collaboration platform designed and actively maintained by Sage Bionetworks (http://synapse.org) that is used to coordinate data across dozens of consortia and collaborations. All data will be aggregated following de-identification and coding by participant identification (ID)/Global Unique Identifier (GUID) within Synapse by Sage Bionetworks for analysis and for distribution to the Data Management Resource (DMR) of the Parkinson's Disease Biomarkers Program (PDBP) of the National Institutes for Health (NIH). The PDBP will ensure de-identified data sharing sharing with the broader research community per its public policies.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: [per PDBP policy]
Access Criteria: [per PDBP policy]
URL: https://pdbp.ninds.nih.gov/policy
Responsible Party Michael Alan Schwarzschild, Massachusetts General Hospital
Study Sponsor Massachusetts General Hospital
Collaborators
  • Northwestern University
  • Sage Bionetworks
  • University of Rochester
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • Michael J. Fox Foundation for Parkinson's Research
  • The Parkinson Study Group
Investigators
Principal Investigator: Michael A Schwarzschild, MD, PhD Massachusetts General Hospital
Principal Investigator: Tanya Simuni, MD Northwestern University
Principal Investigator: E. Ray Dorsey, MD, MBA University of Rochester
Principal Investigator: Lara M Mangravite, PhD Sage Bionetworks
PRS Account Massachusetts General Hospital
Verification Date January 2019