Providing Specialty Care to Individuals With Parkinsonism Directly in Their Homes Via Web-based Video Conferencing— A Comparative Effectiveness Study (TELEMED-PD)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
University of Rochester
Information provided by (Responsible Party):
Dr. Ray Dorsey, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01476306
First received: November 15, 2011
Last updated: November 17, 2011
Last verified: November 2011
  Purpose

The investigators will conduct a two-arm, parallel group, randomized comparative effectiveness study across two sites to increase specialty access and improve care for individuals with Parkinsonism and their caregivers. Twenty individuals with Parkinsonism will be recruited from Johns Hopkins University and the University of Rochester (approximately ten from each site). They will then be randomized to either continue their usual in-person care with a specialist or to receive care with their specialist via telemedicine in their home. Following an in-person baseline/screening visit, approximately ten individuals in the first arm (virtual house calls) will receive three visits with a movement disorder specialist via telemedicine (using web-based video conferencing) in their home. Approximately ten individuals in the second (control) arm will receive three in-person visits at an academic medical center with the same specialists. Approximately two weeks after the completion of each clinical visit, a nurse or coordinator will call the patient to call to address any questions or ensure appropriate understanding of the recommendation (for both telemedicine and control arms). Overall, the study - consistent with a national priority for comparative effectiveness research - will compare the use of telemedicine to manage Parkinsonism to usual care.


Condition Intervention
Parkinson Disease
Other: Telemedicine
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Providing Specialty Care to Individuals With Parkinsonism Directly in Their Homes Via Web-based Video Conferencing— A Comparative Effectiveness Study

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Feasibility [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    Percentage of visits completed as scheduled, number of individuals in telemedicine arm who require in-person visit, number of in-person visits required by individuals in telemedicine arm, proportion of completed telemedicine visits versus in-person visits


Secondary Outcome Measures:
  • Clinical Benefits [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    Unified Parkinson Disease Ration Scale (UPDRS) part III, Montreal Cognitive Assessment (MoCA), Hoehn and Yahr, Patient Assessment of Care for Chronic Conditions (PACIC) Survey, Patient satisfaction

  • Economic impact [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    Travel, time, facilities fees


Estimated Enrollment: 20
Study Start Date: November 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: In-patient care Other: Usual care
Patients in this group will receive care as they usually do with the physician.
Experimental: Telemedicine care Other: Telemedicine
Patient will receive care using HIPAA-compliant web-based videoconferencing rather than their usual in-patient care.

Detailed Description:
  1. Abstract

    The research's overall objective is to improve care for individuals with Parkinsonism. Parkinsonism is clinically determined as the presence of at least 2 of the following: 1) rest tremor, 2) bradykinesia, 3) cogwheel rigidity, or 4) difficulty with gait or balance. The most common cause of Parkinsonism is Parkinson disease. Parkinson disease is a chronic condition whose burden is growing both in the United States and globally. However, access to specialty care is limited chiefly to urban areas and is frequently inefficient. One way to remove geographic barriers to care is through the use of web-based video conferencing (telemedicine).

    To evaluate the study's aims, the investigators will conduct a seven-month randomized controlled study of twenty patients with Parkinsonism across two sites to contrast the comparative effectiveness of standard in-person specialty visits versus those conducted via web-based video conferencing (telemedicine). It is hypothesized that these "virtual house calls" will be feasible, clinically non-inferior to usual care, and economically valuable. This research will expand the geographic scope of specialty care and provide a national model for providing home-based, patient-centered, cost-effective care to those with Parkinsonism anywhere they live.

  2. Objectives (include all primary and secondary objectives)

The specific objectives of the study are as follows:

Aim 1: To evaluate the feasibility of providing specialty care to individuals with Parkinsonism via web-based video conferencing (telemedicine) in their homes by calculating the proportion of specialty visits completed as scheduled.

Hypothesis 1: Individuals receiving care via telemedicine in their homes will complete at least 80% of their visits as scheduled.

Aim 2: To explore the clinical benefits, as measured by the change from baseline in quality of life as measured by the Parkinson Disease Questionnaire 39 (PDQ-39).

Hypothesis 2: In this pilot study, the change in quality of life will be comparable between the two groups.

Aim 3: To explore the economic benefit of providing specialty care via telemedicine in the home.

Hypothesis 3: For patients and caregivers, travel and labor savings from receiving care in the home will outweigh technology costs for telemedicine visits.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The principal eligibility criteria for participants are the following: age greater than 30, clinical diagnosis of idiopathic Parkinsonism, ability to converse in English, ability and willingness to provide informed consent and complete study requirements, and access to a computer with broadband internet.

Exclusion Criteria:

  • The main exclusion criterion is a condition (e.g., prominent psychosis) that in the investigator's judgment would preclude participation in a telemedicine visit. Participants may identify a principal caregiver for optional participation in the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01476306

Locations
United States, Maryland
Johns Hopkins Medical Institutes
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
University of Rochester
  More Information

No publications provided by Johns Hopkins University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Ray Dorsey, Associate Professor of Neurology, Director of the Movement Disorders Center, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01476306     History of Changes
Other Study ID Numbers: 00044310
Study First Received: November 15, 2011
Last Updated: November 17, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
feasibility
effectiveness
Parkinson disease care
care via 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 April 23, 2014