NCT02144220

Brief 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. 1.To demonstrate the feasibility of conducting remote evaluations of patients with Parkinson disease nationally;
  2. 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. 3.To assess the long-term acceptability to patients in receiving ongoing care remotely via telemedicine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
277

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
3 months until next milestone

Results Posted

Study results publicly available

January 9, 2017

Completed
Last Updated

February 23, 2017

Status Verified

January 1, 2017

Enrollment Period

2.4 years

First QC Date

May 19, 2014

Results QC Date

November 10, 2016

Last Update Submit

January 6, 2017

Conditions

Parkinson Disease

Keywords

TelemedicineVirtual care visitRemote visitVideo-conferencing

Outcome Measures

Primary Outcomes (2)

  • Feasibility

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

    6 months

  • 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.

    Baseline and 6 months

Secondary Outcomes (3)

  • Acceptability

    6 months

  • Feasibility (Descriptive)

    6 months

  • Percentage of Patients Who Felt That the Recommendations Improved Their Health

    6 months

Study Arms (1)

Virtual care visit

EXPERIMENTAL

One-time virtual care visit for Parkinson disease.

Other: Virtual care visit

Interventions

Virtual care visitOTHER

Video-conferencing visit with a Parkinson disease specialist

Also known as: Telemedicine visit, Virtual house call
Virtual care visit

Eligibility Criteria

Age30 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of California San Francisco/San Francisco VA Medical Center

San Francisco, California, United States

Location

University of Florida

Gainesville, Florida, 32607, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Related Publications (10)

  • 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.

    PMID: 23479138BACKGROUND

  • 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.

    PMID: 24790799BACKGROUND

  • 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.

    PMID: 17082464BACKGROUND

  • 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.

    PMID: 23616157BACKGROUND

  • 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.

    PMID: 21832214BACKGROUND

  • 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.

    PMID: 23054239BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 19353687BACKGROUND

  • 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.

    PMID: 20533449BACKGROUND

  • 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.

    PMID: 28840919DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Results Point of Contact

Title
Ray Dorsey, MD
Organization
University of Rochester
ray.dorsey@chet.rochester.edu
585-275-0663

Study Officials

  • E. Ray Dorsey, MD, MBA

    University of Rochester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 19, 2014

First Posted

May 21, 2014

Study Start

March 1, 2014

Primary Completion

August 1, 2016

Study Completion

October 1, 2016

Last Updated

February 23, 2017

Results First Posted

January 9, 2017

Record last verified: 2017-01

Locations

US(3)