Parkinson DiseaseAT-HOME PDNCT03538262
Assessing Tele-Health Outcomes in Multiyear Extensions of PD Trials
An observational study of Parkinson Disease, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- How many people
- 226 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 21 Mar 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 1. Inability to carry out study activities as determined by study staff
Trial locations and contacts
1 site in 1 country.
United States1 site
CHeT Telemedicine (Site 363)
Rochester, New York, 14642
About this study
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
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.
Read the 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.
- Conditions
- Parkinson Disease
- Keywords
- SURE-PD3, STEADY-PD III, Parkinson disease, PD, Parkinson Study Group (PSG), Telemedicine, Smartphone, Disease progression, Televisits, Patient-reported outcomes
- Medical subject headings
- Parkinson Disease, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Two years (0, 6, 12, 18, and 24 months)
Secondary outcomes (12)
Change in Tele-visit MDS-UPDRS Part 1a (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 (i.e., the first six questions of part 1). The MDS-UPDRS is assessed on a 5-point Likert scale ranging from 0 to 4 where higher scores imply worse features. Part 1a scores may range from a minimum of 0 to a maximum of 24, with higher values meaning worse disability.
Measured: Two years (0, 12, and 24 months)
Change in Tele-visit MDS-UPDRS Part 1b (Score)
The Movement Disorders Society Unified PD Rating Scale (MDS-UPDRS) Part Ib is the patient-reported portion of Part I, and assesses non-motor experiences of daily living. The MDS-UPDRS is assessed on a 5-point Likert scale ranging from 0 to 4 where higher scores imply worse symptoms. Part Ib contains 7 questions, and its scores may range from a minimum of 0 to a maximum of 28, with higher values meaning worse symptoms.
Measured: Two years (0, 12, and 24 months)
Change in Tele-visit Modified MDS-UPDRS Part 3 (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 (modified) part 3. This measure omits 5 questions related to rigidity and 1 question related to postural instability, with a range from 0 to 108. The MDS-UPDRS is assessed on a 5-point Likert scale ranging from 0 to 4 where higher scores imply worse features.
Measured: Two years (0, 12, and 24 months)
Change in Tele-visit Montreal Cognitive Assessment (MoCA; Score)
The Montreal Cognitive Assessment (MoCA) assesses attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Points are awarded for the correct completion of MoCA tasks. Scores for each task are summed for a total score (range 0-30). Higher scores indicate greater cognitive capacity.
Measured: Two years (0, 12, and 24 months)
Change in Tele-visit Schwab and England (S&E; Score)
The Schwab and England scale is a Site Investigator and subject assessment of the subject's level of independence. The subject will be scored on a percentage scale reflecting his/her ability to perform acts of daily living. Printed scores with associated descriptors range from 0% to 100% in increments of 5%, with higher percentages associated with more independence. A score of 0% implies "vegetative functions such as swallowing, bladder and bowel functions are not functioning; bedridden". A score of 100% implies "subject has full ability and is completely independent; essentially normal".
Measured: Two years (0, 12, and 24 months)
Change in Tele-visit Clinician Global Impression - Severity (CGIS; Score)
The Clinician Global Impression (CGI) is an observer-rated scale that measures illness severity (CGIS). The CGIS is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through 7 (amongst the most severely ill patients).
Measured: Two years (0, 12, and 24 months)
Change in Fox Insight Parkinson's Disease Questionnaire - 8 Item Version (PDQ-8; Score)
The Fox Insight PDQ-8 (Parkinson's Disease Questionnaire, short-form 8 item version) is a self-administered questionnaire used to measure quality of life in persons with Parkinson's disease. The response to each question is assessed on a 5-point Likert scale ranging from 0 to 4 where higher scores imply worse symptoms. Scores range from a minimum of 0 to a maximum of 32, with a higher score indicating a poorer quality of life.
Measured: Two years (0, 3, 6, 9, 12, 15, 18, 21, and 24 months)
Change in Fox Insight EuroQol Five Dimensions Questionnaire (EQ-5D; Score)
The Fox Insight EQ-5D (European Quality of life survey) is a standardized measure of health-related quality of life assessing five dimensions of health. It comprises five corresponding questions on mobility, self-care, pain, usual activities, and psychological status with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem). A derived summary index score is higher with better health-related quality of life. A maximum of 1 corresponds to the best quality of life, whereas a score of 0 is intended to approximate a state equivalent to death, with values less than 1 corresponding to a state worse than death.
Measured: Two years (0, 6, 12, 18, and 24 months)
Change in Fox Insight Non-motor Symptoms Questionnaire (NMS-QUEST; Score)
The Non-motor Symptoms Questionnaire (NMS-QUEST) is a 30-question self-reported assessment. Each question is of a yes/no format with a score of 1 given to each "yes" answer, with total scores ranging from 0-30, with higher scores indicating a greater number of non-motor symptoms. Participants completed the assessment online in Fox Insight.
Measured: Two years (0, 3, 6, 9, 12, 15, 18, 21, and 24 months)
Change in Fox Insight REM (Rapid Eye Movement) Behavior Disorder (RBD; Score)
The Fox Insight Rapid Eye Movement Behavior Disorder (RBD) score is a patient-reported binary ("no" or "yes") response to a single question of whether they act out their dreams while asleep. Participants report their response online through the Fox Insight web-based platform. The score value is dichotomous (or missing) and ranges from 0 (no symptom) to 1 (yes response).
Measured: 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)
The Parkinson's Daily Activities Questionnaire -15 (PDAQ-15) is a 15-item measure of activities of daily living (ADL) that are impacted by cognitive impairment in participants with Parkinson's disease. The PDAQ-15 is derived from the original 50-item scale and is completed by the participant in Fox Insight. Scores range from 0 to 60, with higher scores indicating better function.
Measured: Two years (0, 3, 9, 15, and 21 months)
Change in Fox Insight Geriatric Depression Scale (GDS; Score)
The Geriatric Depression Scale (GDS) is a measure of depression completed by the participant online in Fox Insight. The scale has 30 yes/no questions, with each question having a maximum score of 1 and a total possible score ranging from 0 to 30. The higher the score, the greater the depression.
Measured: Two years (0, 12, and 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start1 Oct 2018
- Primary completion21 Mar 2022
- Study completion21 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Michael Alan Schwarzschild, Massachusetts General Hospital
- Investigators
- Michael A Schwarzschild, MD, PhD, Principal investigator, Massachusetts General HospitalTanya Simuni, MD, Principal investigator, Northwestern UniversityE. Ray Dorsey, MD, MBA, Principal investigator, University of RochesterLarsson Omberg, PhD, Principal investigator, Sage Bionetworks
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538262
- Sponsor's protocol ID
- AHPD-U01NS107009
- Other IDs
- U01NS090259-01A1, U01NS080818-01A1, U01NS080840-01A1
- Acronym
- AT-HOME PD
- Status last verified
- Apr 2023
- First submitted
- 16 Apr 2018
- Last updated
- 12 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03538262
- Acronym / sponsor ID
- AT-HOME PD / AHPD-U01NS107009
- Conditions
- Parkinson Disease
- Keywords
- SURE-PD3, STEADY-PD III, Parkinson disease, PD, Parkinson Study Group (PSG), Telemedicine, Smartphone, Disease progression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- 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
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 21 Mar 2022 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 29 May 2018 (actual)
- Results
- Posted 12 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- 1. Inability to carry out study activities as determined by study staff
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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. 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 Tele-visit MDS-UPDRS Part 2 (Score)
Time frame: 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 Smartphone Tapping (Score)
Time frame: 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 Fox Insight MDS-UPDRS Part 2 (Score)
Time frame: 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.
12 secondary outcomes
Change in Tele-visit MDS-UPDRS Part 1a (Score)
Time frame: Two years (0, 12, and 24 months)
Change in Tele-visit MDS-UPDRS Part 1b (Score)
Time frame: Two years (0, 12, and 24 months)
Change in Tele-visit Modified MDS-UPDRS Part 3 (Score)
Time frame: Two years (0, 12, and 24 months)
Change in Tele-visit Montreal Cognitive Assessment (MoCA; Score)
Time frame: Two years (0, 12, and 24 months)
Change in Tele-visit Schwab and England (S&E; Score)
Time frame: Two years (0, 12, and 24 months)
Change in Tele-visit Clinician Global Impression - Severity (CGIS; Score)
Time frame: Two years (0, 12, and 24 months)
Change in 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)
Change in Fox Insight EuroQol Five Dimensions Questionnaire (EQ-5D; Score)
Time frame: Two years (0, 6, 12, 18, and 24 months)
Change in Fox Insight Non-motor Symptoms Questionnaire (NMS-QUEST; Score)
Time frame: Two years (0, 3, 6, 9, 12, 15, 18, 21, and 24 months)
Change in Fox Insight REM (Rapid Eye Movement) Behavior Disorder (RBD; Score)
Time frame: 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)
Time frame: Two years (0, 3, 9, 15, and 21 months)
Change in Fox Insight Geriatric Depression Scale (GDS; Score)
Time frame: Two years (0, 12, and 24 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A nonprofit scientific network of North American centers for clinical studies of Parkinson diseaseLink provided by the sponsor.
- Parkinson's Disease BIomarkers Program (PDBP) of the National Institute of Neurological Disorders and Stroke (NINDS)Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Center for Health + Technology (CHET) of the University of Rochester; lead site for the tele-visit platform of AT-HOME PD.Link provided by the sponsor.
- Fox Insight; online platform for the collection of patient-reported outcomes in AT-HOME PD.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A Schwarzschild, MD, PhD principal investigator
Massachusetts General Hospital
Tanya Simuni, MD principal investigator
Northwestern University
E. Ray Dorsey, MD, MBA principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Tele-visit Modified MDS-UPDRS Parts 1-3 (Total Score) (time frame: Two years (0, 12, and 24 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.