CClinicalTrials.gg
CompletedNCT02144220RACE-PDUpdated Feb 23, 2017Results posted

Remote Access to Care, Everywhere, for Parkinson Disease

An interventional study of Virtual care visit in Parkinson Disease, sponsored by University of Rochester. Completed at 3 sites in United States. Open to participants aged 30 Years to 120 Years. Per ClinicalTrials.gov, last updated 2017-02-23.

Sponsored by University of Rochester · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
277
Allocation
Not applicable
Ages
30 Years to 120 Years
Sex
All
01

Study summary

The primary objective of this study is to evaluate the feasibility, efficacy and the value of providing care to individuals with Parkinson disease directly into their homes. The specific aims are:

  1. To demonstrate the feasibility of conducting remote evaluations of patients with Parkinson disease nationally;
  2. To measure the impact of remote care on each patient's ability to improve his or her quality of life (QoL) and better manage his or her Parkinson disease; and
  3. To assess the long-term acceptability to patients in receiving ongoing care remotely via telemedicine.
02

Conditions studied

  • Parkinson Disease

Browse trials for

Keywords

  • Telemedicine
  • Virtual care visit
  • Remote visit
  • Video-conferencing
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 277 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age greater than 30
  • Self reported diagnosis of idiopathic Parkinson disease
  • Ability to converse in English
  • Ability and willingness to provide informed consent and complete study requirements
  • Access to a non-public computer or similar devices with broadband internet.
  • Located in New York, Maryland, Delaware, California, or Florida at time of virtual visit (or veterans with Parkinson disease anywhere in the U.S.)

Exclusion criteria

Exclusion Criteria:

  • Any condition (e.g.prominent psychosis) that in the investigator's or coordinator's judgment would preclude participation.
  • Concurrent enrollment in another telemedicine study.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
277 participants (actual)

Study arms

  • Experimental
    Virtual care visit

    One-time virtual care visit for Parkinson disease.

    Other: Virtual care visit

Interventions

  • OtherVirtual care visit

    Video-conferencing visit with a Parkinson disease specialist

    Also known as: Telemedicine visit, Virtual house call

06

What researchers measure

Primary outcomes

  1. Feasibility

    The percent of telemedicine visits completed as scheduled. (Goal \>80%)

    Time frame: 6 months

  2. Change in Quality of Life as Measured by the PDQ-39 Assessment Tool

    The impact on Quality of life (QoL) as measured by the change in PDQ-39 score from baseline to 6 months. The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the last month. 5-point ordinal scoring system: 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, 4 = always. Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better quality of life.

    Time frame: Baseline and 6 months

Secondary outcomes

  1. Acceptability

    - The percent of patients participated who stated that they are interested in receiving ongoing care for their PD via telemedicine. (Goal \>80%)

    Time frame: 6 months

  2. Feasibility (Descriptive)

    Percentage of physician visits where the physician was were satisfied or very satisfied with the virtual visit overall.

    Time frame: 6 months

  3. Percentage of Patients Who Felt That the Recommendations Improved Their Health

    Time frame: 6 months

07

Results

Posted Jan 9, 2017

Participant flow

Recruitment was primarily online through mass email messaging from the Davis Phinney Foundation, internet listings on Fox Trial Finder, messages from PatientsLikeMe, Google AdWords in eligible states, and outreach to support groups.

Participant flow — Overall Study
MilestoneVirtual Care Visit
Started277
Completed258
Not completed19
Withdrew: Technology incompatibility9
Withdrew: Lack of efficacy4
Withdrew: Physician decision3
Withdrew: Withdrawal by subject2
Withdrew: Protocol violation1

Outcome measures

PrimaryFeasibility

The percent of telemedicine visits completed as scheduled. (Goal \>80%)

Time frame:
6 months
Reported as:
Number · percentage of visits
Feasibility
percentage of visitsVirtual Care Visit
Feasibility91
PrimaryChange in Quality of Life as Measured by the PDQ-39 Assessment Tool

The impact on Quality of life (QoL) as measured by the change in PDQ-39 score from baseline to 6 months. The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the last month. 5-point ordinal scoring system: 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, 4 = always. Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better quality of life.

Time frame:
Baseline and 6 months
Reported as:
Number · units on a scale
Change in Quality of Life as Measured by the PDQ-39 Assessment Tool
units on a scaleVirtual Care Visit
Change in Quality of Life as Measured by the PDQ-39 Assessment Tool0.4 (-1.5 to 0.6)
Statistical analysis
  • Virtual Care Visit · t-test, 2 sided · p = 0.39
SecondaryAcceptability

- The percent of patients participated who stated that they are interested in receiving ongoing care for their PD via telemedicine. (Goal \>80%)

Time frame:
6 months
Reported as:
Number · percentage of participants
Acceptability
percentage of participantsVirtual Care Visit
Acceptability74
SecondaryFeasibility (Descriptive)

Percentage of physician visits where the physician was were satisfied or very satisfied with the virtual visit overall.

Time frame:
6 months
Reported as:
Number · percentage of visits
Feasibility (Descriptive)
percentage of visitsVirtual Care Visit
Feasibility (Descriptive)94
SecondaryPercentage of Patients Who Felt That the Recommendations Improved Their Health
Time frame:
6 months
Reported as:
Number · percentage of participants
Percentage of Patients Who Felt That the Recommendations Improved Their Health
percentage of participantsVirtual Care Visit
Percentage of Patients Who Felt That the Recommendations Improved Their Health56

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Virtual Care Visit—0/277 (0%)0/277 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Virtual Care Visit
Mean67.1 ± 9.1
Gender
Gender(Participants)Virtual Care Visit
Female138
Male139
Region of Enrollment
Region of Enrollment(participants)Virtual Care Visit
United States277
08

Study locations

3 sites
  • University of California San Francisco/San Francisco VA Medical Center
    San Francisco, California, United States
  • University of Florida
    Gainesville, Florida 32607, United States
  • University of Rochester Medical Center
    Rochester, New York 14642, United States
09

References and documents

Publications

  • Dorsey ER, Venkataraman V, Grana MJ, Bull MT, George BP, Boyd CM, Beck CA, Rajan B, Seidmann A, Biglan KM. Randomized controlled clinical trial of "virtual house calls" for Parkinson disease. JAMA Neurol. 2013 May;70(5):565-70. doi: 10.1001/jamaneurol.2013.123. PubMed 23479138 ↗
  • Venkataraman V, Donohue SJ, Biglan KM, Wicks P, Dorsey ER. Virtual visits for Parkinson disease: A case series. Neurol Clin Pract. 2014 Apr;4(2):146-152. doi: 10.1212/01.CPJ.0000437937.63347.5a. PubMed 24790799 ↗
  • Dorsey ER, Constantinescu R, Thompson JP, Biglan KM, Holloway RG, Kieburtz K, Marshall FJ, Ravina BM, Schifitto G, Siderowf A, Tanner CM. Projected number of people with Parkinson disease in the most populous nations, 2005 through 2030. Neurology. 2007 Jan 30;68(5):384-6. doi: 10.1212/01.wnl.0000247740.47667.03. Epub 2006 Nov 2. PubMed 17082464 ↗
  • Dorsey ER, George BP, Leff B, Willis AW. The coming crisis: obtaining care for the growing burden of neurodegenerative conditions. Neurology. 2013 May 21;80(21):1989-96. doi: 10.1212/WNL.0b013e318293e2ce. Epub 2013 Apr 24. PubMed 23616157 ↗
  • Willis AW, Schootman M, Evanoff BA, Perlmutter JS, Racette BA. Neurologist care in Parkinson disease: a utilization, outcomes, and survival study. Neurology. 2011 Aug 30;77(9):851-7. doi: 10.1212/WNL.0b013e31822c9123. Epub 2011 Aug 10. PubMed 21832214 ↗
  • Willis AW, Schootman M, Tran R, Kung N, Evanoff BA, Perlmutter JS, Racette BA. Neurologist-associated reduction in PD-related hospitalizations and health care expenditures. Neurology. 2012 Oct 23;79(17):1774-80. doi: 10.1212/WNL.0b013e3182703f92. Epub 2012 Oct 10. PubMed 23054239 ↗
  • The European Parkinson's Disease Association. The european parkinson's disease standards of care consensus statement. http://www.kompetenznetzparkinson.de/EPDA_Parkinson_s_Standard_nsus_Statement_Vol_I.pdf>2013.
  • Biglan KM, Voss TS, Deuel LM, Miller D, Eason S, Fagnano M, George BP, Appler A, Polanowicz J, Viti L, Smith S, Joseph A, Dorsey ER. Telemedicine for the care of nursing home residents with Parkinson's disease. Mov Disord. 2009 May 15;24(7):1073-6. doi: 10.1002/mds.22498. PubMed 19353687 ↗
  • Dorsey ER, Deuel LM, Voss TS, Finnigan K, George BP, Eason S, Miller D, Reminick JI, Appler A, Polanowicz J, Viti L, Smith S, Joseph A, Biglan KM. Increasing access to specialty care: a pilot, randomized controlled trial of telemedicine for Parkinson's disease. Mov Disord. 2010 Aug 15;25(11):1652-9. doi: 10.1002/mds.23145. PubMed 20533449 ↗
  • Korn RE, Wagle Shukla A, Katz M, Keenan HT, Goldenthal S, Auinger P, Zhu W, Dodge M, Rizer K, Achey MA, Byrd E, Barbano R, Richard I, Andrzejewski KL, Schwarz HB, Dorsey ER, Biglan KM, Kang G, Kanchana S, Rodriguez R, Tanner CM, Galifianakis NB. Virtual visits for Parkinson disease: A multicenter noncontrolled cohort. Neurol Clin Pract. 2017 Aug;7(4):283-295. doi: 10.1212/CPJ.0000000000000371. PubMed 28840919 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02144220
Lead sponsor
University of Rochester
Collaborators
Davis Phinney Foundation
Responsible party
Ray Dorsey (Professor, University of Rochester) — Principal investigator
First posted
May 21, 2014
Start date
Mar 2014
Primary completion
Aug 2016
Completion
Oct 2016
Results posted
Jan 9, 2017
Last update
Feb 23, 2017

Study contacts

E. Ray Dorsey, MD, MBA
principal investigator · University of Rochester

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion