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Trial record 2 of 13 for:    Steady PD III

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03538262
Recruitment Status : Recruiting
First Posted : May 29, 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

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.

Condition or disease
Parkinson Disease

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.

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Study Type : Observational
Estimated Enrollment : 420 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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.

  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.

  3. 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.

  4. 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.

  5. 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).


Secondary Outcome Measures :
  1. Tele-visit MDS-UPDRS part 1a (score) [ Time Frame: Two years (0, 12, and 24 months) ]
  2. Tele-visit MDS-UPDRS part 1b (score) [ Time Frame: Two years (0, 12, and 24 months) ]
  3. Tele-visit Modified MDS-UPDRS part 3 (score) [ Time Frame: Two years (0, 12, and 24 months) ]
  4. Tele-visit Montreal Cognitive Assessment (MoCA; score) [ Time Frame: Two years (0, 12, and 24 months) ]
  5. Tele-visit Schwab and England (S&E; score) [ Time Frame: Two years (0, 12, and 24 months) ]
  6. Tele-visit Clinician Global Impression (CGI; score) [ Time Frame: Two years (0, 12, and 24 months) ]
  7. Smartphone cognitive assessment (score) [ Time Frame: Two years (0, 3, 6, 9, 12, 15, 18, 21, and 24 months) ]
  8. 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) ]
  9. Fox Insight EuroQol Five Dimensions Questionnaire (EQ-5D; score) [ Time Frame: Two years (0, 6, 12, 18, and 24 months) ]
  10. Fox Insight Non-motor Symptoms Questionnaire (NMS-QUEST; score) [ Time Frame: Two years (0, 3, 6, 9, 12, 15, 18, 21, and 24 months) ]
  11. Fox Insight REM (Rapid Eye Movement) Behavior Disorder (RBD; score) [ Time Frame: Two years (0, 3, and 15 months) ]
  12. Fox Insight Parkinson's Daily Activities Questionnaire -15 (PDAQ-15; score) [ Time Frame: Two years (0, 3, 9, 15, and 21 months) ]
  13. Fox Insight Geriatric Depression Scale (GDS; score) [ Time Frame: Two years (0, 12, and 24 months) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03538262


Contacts
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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

Locations
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United States, New York
CHeT Telemedicine (Site 363) Recruiting
Rochester, New York, United States, 14642
Contact: Sidney Duquette    585-725-2813    sidney.duquette@chet.rochester.edu   
Contact: Elizabeth Baloga, MPH    585-273-5571    elizabeth.baloga@chet.rochester.edu   
Sponsors and Collaborators
Massachusetts General Hospital
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
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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

Additional Information:
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Responsible Party: Michael Alan Schwarzschild, Professor of Neurology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: 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 )
First Posted: May 29, 2018    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: January 2019
Individual Participant Data (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
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: [per PDBP policy]
Access Criteria: [per PDBP policy]
URL: https://pdbp.ninds.nih.gov/policy

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Alan Schwarzschild, Massachusetts General Hospital:
SURE-PD3
STEADY-PD III
Parkinson disease
PD
Parkinson Study Group (PSG)
Telemedicine
Smartphone
Disease progression
Televisits
Patient-reported outcomes
Additional relevant MeSH terms:
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Parkinson Disease
Disease Progression
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Disease Attributes
Pathologic Processes