Pilot Randomized Controlled Trial of Telemedicine for Individuals With Parkinson Disease in a Rural Population - Full Text View

Sponsors and Collaborators:	University of Rochester Presbyterian Home for Central New York, Inc.
Information provided by:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00668551

Purpose

To eliminate barriers (such as travel and cost) to specialized Parkinson disease (PD) care, two movement disorder specialists at the University of Rochester will be providing telemedicine visits for patients with PD who reside in the Presbyterian Home for Central New York in New Hartford, NY, or for individuals who participate in the local support group that meets at the nursing home. Participants will attend 3 telemedicine visits at the Presbyterian Home over the course of 6 months.

We hypothesize that this telemedicine model will in time improve access to care and hence the quality of life and quality of care of individuals with PD.

Condition
Parkinson Disease

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease Rural Health Concerns

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Pilot Randomized Controlled Trial of Telemedicine for Individuals With Parkinson Disease in a Rural Population

Further study details as provided by University of Rochester:

Primary Outcome Measures:

The feasibility of telemedicine, based on participant ability to complete 75% or more of the trial visits. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Parkinson's Disease Questionnaire-39 (PDQ-39) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
EuroQol (EQ-5D) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Geriatric Depression Scale Short Form (GDS-15) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Modified Group Health Association of America's Consumer Satisfaction Survey (GHAA) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Qualitative assessment, including a telemedicine focus group and 1:1 interviews with study participants [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	14
Study Start Date:	April 2008
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Telemedicine care
2 Standard of care

Detailed Description:

Study participants are recruited from the Presbyterian Home and from the Central New York Parkinson Support Group. Anyone interested will attend a screening and baseline visit at the Presbyterian Home, where they will receive baseline surveys and a motor assessment. Eligible participants will be randomized to receive either telemedicine or standard of care.

Each telemedicine visit (Month 1, Month 3, Month 6) will take place in a 1:1 fashion between the study participant and the physician investigator - one of two movement disorder specialists from the University of Rochester - via televideo linkage, and will last approximately 30-60 minutes. The study participant will be observed by the physician investigator and she/he will be accompanied by a Presbyterian Home staff member to ensure safety throughout the telemedicine visit. The visit will be structured much the same as a standard clinical visit and will include:

Study participant's update on his or her clinical condition
Review of current medications, which will be provided in advance of the visit
Review and update of medical and social histories
Vital signs, including weight (provided by the Presbyterian Home staff)
Pertinent neurological exam, including a modified motor examination led by physician investigator
Assessment of current clinical state
Dictated recommendations including a letter to the attending physician for ongoing clinical care, including changes to the PD medications

Participants assigned to the control group will receive their care as routinely scheduled with their own primary care physician and/or neurologist.

Staff members from the University of Rochester will return to the Presbyterian Home within one month of the six month study to complete final assessments with all study participants. These will include:

Reportable events form
Health care events form
Quality of life and healthcare evaluation surveys
Continuation of care survey
1:1 interviews
Telemedicine focus groups

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Study participants will be recruited from the Presbyterian Home Parkinson disease nursing home, assisted living, independent living, and adult day care populations, as well as the local PD support group that meets monthly at the Presbyterian Home.

Criteria

Inclusion Criteria:

Willing and able to provide informed consent
Age 30 years old or older
Clinical diagnosis of idiopathic Parkinson's disease as determined by having two of the four cardinal features of PD (rest tremor, bradykinesia, cogwheel rigidity, and gait instability) and no better alternative explanation for the etiology of the symptoms
Able to converse in English
Willing and able to complete study requirements

Exclusion Criteria:

Any neurological, medical, or psychiatric condition that would preclude the patient having the ability to provide informed consent or to participate in the telemedicine visit.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668551

Locations

United States, New York
Presbyterian Home for Central New York, Inc.
New Hartford, New York, United States, 13413

Sponsors and Collaborators

University of Rochester

Presbyterian Home for Central New York, Inc.

Investigators

Principal Investigator:	E. Ray Dorsey, MD, MBA	University of Rochester
Principal Investigator:	Kevin Biglan, MD, MPH	University of Rochester

More Information

Publications:

Hubble JP, Pahwa R, Michalek DK, Thomas C, Koller WC. Interactive video conferencing: a means of providing interim care to Parkinson's disease patients. Mov Disord. 1993 Jul;8(3):380-2.

Cheng EM, Swarztrauber K, Siderowf AD, Eisa MS, Lee M, Vassar S, Jacob E, Vickrey BG. Association of specialist involvement and quality of care for Parkinson's disease. Mov Disord. 2007 Mar 15;22(4):515-22.

McConnochie KM, Wood NE, Kitzman HJ, Herendeen NE, Roy J, Roghmann KJ. Telemedicine reduces absence resulting from illness in urban child care: evaluation of an innovation. Pediatrics. 2005 May;115(5):1273-82.

Samii A, Ryan-Dykes P, Tsukuda RA, Zink C, Franks R, Nichol WP. Telemedicine for delivery of health care in Parkinson's disease. J Telemed Telecare. 2006;12(1):16-8.

Responsible Party:	University of Rochester ( E. Ray Dorsey, MD, MBA )
Study ID Numbers:	RSRB00022923
Study First Received:	April 25, 2008
Last Updated:	April 25, 2008
ClinicalTrials.gov Identifier:	NCT00668551
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Rochester:

Parkinson disease
Telemedicine

Study placed in the following topic categories:

Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009