Text Size

Pilot Randomized Controlled Trial of Telemedicine for Individuals With Parkinson Disease in a Rural Population (Tele-PD)

This study has been completed.
Sponsor:
Collaborator:
Presbyterian Home for Central New York, Inc.
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00668551
First received: April 25, 2008
Last updated: April 10, 2009
Last verified: April 2009
History of Changes
  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

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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 14
Study Start Date: April 2008
Study Completion Date: November 2008
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:

Responsible Party: E. Ray Dorsey, MD, MBA, University of Rochester
ClinicalTrials.gov Identifier: NCT00668551     History of Changes
Other Study ID Numbers: RSRB00022923
Study First Received: April 25, 2008
Last Updated: April 10, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Parkinson disease
Telemedicine

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on June 18, 2013