Assessing Tele-Health Outcomes in Multiyear Extensions of PD Trials

NCT03538262 | Completed Results

• 4 other identifiers: AHPD-U01NS107009U01NS090259-01A1U01NS080818-01A1U01NS080840-01A1
• Study Type: observational
• Target: 226
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

SURE-PD3; STEADY-PD III; Parkinson disease; PD; Parkinson Study Group (PSG); Telemedicine; Smartphone; Disease progression; Televisits; Patient-reported outcomes

Outcome Measures

Primary Outcomes (4)

• Change in Tele-visit Modified MDS-UPDRS Parts 1-3 (Total Score)

  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.

  Two years (0, 12, and 24 months)

• Change in Tele-visit MDS-UPDRS Part 2 (Score)

  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.

  Two years (0, 12, and 24 months)

• Change in Smartphone Tapping (Score)

  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.

  Two years (0, 3, 6, 9, 12 , 15, 18, 21, and 24 months)

• Change in Fox Insight MDS-UPDRS Part 2 (Score)

  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.

  Two years (0, 6, 12, 18, and 24 months)

Secondary Outcomes (12)

• 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 Tele-visit Modified MDS-UPDRS Part 3 (Score)

  Two years (0, 12, 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)

Study Arms (1)

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.

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \. Inability to carry out study activities as determined by study staff

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Northwestern University: collaborator
• Sage Bionetworks: collaborator
• University of Rochester: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Michael J. Fox Foundation for Parkinson's Research: collaborator
• The Parkinson Study Group: collaborator

Study Sites (1)

CHeT Telemedicine (Site 363)

Rochester, New York, 14642, United States

Location

Related Links

• A nonprofit scientific network of North American centers for clinical studies of Parkinson disease
• Parkinson's Disease BIomarkers Program (PDBP) of the National Institute of Neurological Disorders and Stroke (NINDS)
• A nonprofit organization promoting open bioinformatics science and patient engagement in the research process; lead site for the smartphone app platform of AT-HOME PD.
• Center for Health + Technology (CHET) of the University of Rochester; lead site for the tele-visit platform of AT-HOME PD.
• Fox Insight; online platform for the collection of patient-reported outcomes in AT-HOME PD.

MeSH Terms

Conditions

Parkinson Disease; Disease Progression

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Per the study protocol, certain smartphone cognitive assessments were planned. However, smartphone cognitive assessments were not completed in this study due to the measures still being validated at the time of the study launch and being deployed too late to collect longitudinal data on the cohort.

Results Point of Contact

• Title: Dr. Michael Schwarzschild
• Organization: Massachusetts General Hospital

michaels@helix.mgh.harvard.edu

617-724-9611

Study Officials

• 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

• Larsson Omberg, PhD

  Sage Bionetworks

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: May 29, 2018
• Study Start: October 1, 2018
• Primary Completion: March 21, 2022
• Study Completion: March 21, 2022
• Last Updated: June 12, 2023
• Results First Posted: June 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: \[per PDBP policy\]
• Access Criteria: \[per PDBP policy\]

Locations

US (1)