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Parkinson DiseaseRACE-PDNCT02144220

Remote Access to Care, Everywhere, for Parkinson Disease

A study testing Virtual care visit in people with Parkinson Disease, run by University of Rochester at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 120 years
Conditions the study is for
Parkinson Disease
What is being tested?
Virtual care visit
Could I receive a placebo?
No, everyone receives an active treatment
How many people
277 participants
Where
3 sitesUnited States
Study dates
Mar 2014to Oct 2016
Phase
Interventional
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 30 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.)

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University of Florida

    Gainesville, Florida, 32607

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • University of California San Francisco/San Francisco VA Medical Center

    San Francisco, California

Other trials in United States

About this study

Official title: Remote Access to Care, Everywhere: Using Telemedicine to Deliver Patient-centered Care to Patients With Parkinson Disease

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.
Being tested
Virtual care visit
Keywords
Telemedicine, Virtual care visit, Remote visit, Video-conferencing
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual care visitOther

    Also called Telemedicine visit, Virtual house call

    Video-conferencing visit with a Parkinson disease specialist

Study groups in NCT02144220
Study groupRoleWhat they receive
Virtual care visitExperimentalOne-time virtual care visit for Parkinson disease.
Receives: Other: Virtual care visit

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility

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

    Measured: 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.

    Measured: Baseline and 6 months

Secondary outcomes (3)

  1. Acceptability

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

    Measured: 6 months

  2. Feasibility (Descriptive)

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

    Measured: 6 months

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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionAug 2016
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
277 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02144220
Sponsor's protocol ID
RSRB-50627
Acronym
RACE-PD
Status last verified
Jan 2017
First submitted
19 May 2014
Last updated
23 Feb 2017
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Virtual care visit in people with Parkinson Disease, run by University of Rochester at 3 sites 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 6 inclusion and 2 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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 9 Jan 2017). 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?

Feasibility (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02144220, which also lists 10 linked publications.

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 23 Feb 2017.

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