Trial record 2 of 1336 for:    "Parkinson's Disease "

Connect.Parkinson: Connecting Individuals With Parkinson Disease to Specialists in Their Homes

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Rochester
Sponsor:
Collaborators:
Patient Centered Outcome Research Institute
National Parkinson Foundation
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT02038959
First received: January 8, 2014
Last updated: July 18, 2014
Last verified: June 2014
  Purpose

Connect.Parkinson is a randomized comparative effectiveness study, comparing usual care enhanced with educational materials to usual care, educational materials, and the delivery of specialty care via telemedicine into patient's homes. The study's specific aims are the following:

  1. To demonstrate the feasibility of using telemedicine to deliver specialty care into the homes of individuals with Parkinson disease who have limited access to care;
  2. To show that such an approach can improve quality of life;
  3. To establish that the telemedicine can enhance the quality of care; and
  4. To demonstrate that this remote approach to care saves time, reduces travel, and decreases care partner burden.

Condition Intervention
Parkinson Disease
Other: Virtual Visits

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Using Technology to Deliver Multi-disciplinary Care to Individuals With Parkinson Disease in Their Homes: the Connect.Parkinson Study

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Feasibility of Virtual Visits for Parkinson Disease [ Time Frame: One year ] [ Designated as safety issue: No ]
    Feasibility of virtual visits will be determined by the number of participants who complete at least one virtual visit successfully.

  • Efficacy of care provided via virtual visits [ Time Frame: One year ] [ Designated as safety issue: No ]
    Assessed as the change in quality of life, measured by the Parkinson Disease Questionnaire 39 (PDQ-39).


Secondary Outcome Measures:
  • Overall Quality of Life [ Time Frame: One year ] [ Designated as safety issue: No ]
    We will measure the change in overall quality of life reported from baseline to the end of the study using the EuroQoL 5D-5L.

  • Patient Global Impression of Change [ Time Frame: One year ] [ Designated as safety issue: No ]
    At the conclusion of the study, participants will be asked to describe how they feel their health has changed since the beginning of the study.

  • Cognition [ Time Frame: One year ] [ Designated as safety issue: No ]
    We will assess changes in cognition from baseline to the end of the study using the Montreal Cognitive Assessment (MoCA), administered remotely.

  • Parkinson disease severity [ Time Frame: One year ] [ Designated as safety issue: No ]
    Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS).

  • Quality of Care [ Time Frame: One year ] [ Designated as safety issue: No ]
    We will assess change in the perceived quality of care using the Patient Assessment of Chronic Illness Care (PACIC).

  • Value to patients and care partners [ Time Frame: One year ] [ Designated as safety issue: No ]
    We will assess value to patients and caregivers using questions about time and travel to Parkinson disease appointments, as well as healthcare resource utilization (including hospitalizations and other visits).

  • Care partner burden [ Time Frame: One year ] [ Designated as safety issue: No ]
    Measured as the change in the Multidimensional Caregiver Strain Index (MCSI).


Estimated Enrollment: 480
Study Start Date: March 2014
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care and Educational Materials
Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
Experimental: Virtual Visits and Educational Materials
Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.
Other: Virtual Visits
Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone).
Other Names:
  • Telemedicine
  • Teleneurology
  • Video call
  • Video conferencing
No Intervention: Care partners
Care partners will be enrolled with the participants for whom they care. Care partners will complete a survey at baseline and at the end of the study, including assessments of time and travel for assisting with Parkinson disease visits and the Multidimensional Caregiver Strain Index (MCSI).

Detailed Description:

Connect.Parkinson is a national study examining the feasibility and effectiveness of using video calls to bring expert Parkinson disease care directly into patients' homes. Currently, access to care for Parkinson disease is limited by distance, disability, and the distribution of doctors. Approximately 200 individuals with Parkinson disease (who due to distance, disability, disparity, or doctor distribution have limited access to care) will be randomized to one of two arms in this comparative effectiveness study. The first (control) arm will be the individual's "usual care" supplemented by educational materials on their condition. This usual care may include care from a generalist, care from a neurologist, or in-person care from a Parkinson specialist. The care received by the control group will vary but will be an accurate reflection of usual care in this country. The second (intervention) arm will be usual care supplemented by educational materials and care from a Parkinson disease specialist delivered via web-based video conferencing into the patient's home. The participants will also be asked with they have a primary care partner, and care partners will be invited to enroll, for a total of approximately 400 participants.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Individuals with clinically diagnosed Idiopathic Parkinson disease in the judgment of the independent rater
  • No better alternative explanation for the parkinsonism
  • Access to a non-public, internet-enabled device (e.g., computer, tablet computer, smart phone) that has the capacity for web-based video conferencing
  • Be physically located at time visits are conducted in a state where the participating physician is licensed to practice medicine
  • Have a local care provider that the study team can contact
  • Live at home, in a senior housing complex, or assisted living facility
  • Be fluent in English (all participating states) or Spanish (participants in Florida and Massachusetts only)
  • Willing and able to provide informed consent
  • Care partner (if applicable) must be able and willing to provide informed consent to participate if he or she so chooses.

Exclusion Criteria:

  • Currently hospitalized
  • Condition (e.g., prominent psychosis) that precludes study participation as identified by the medical professional (site investigator or nurse).
  • Participation in another telemedicine study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02038959

Contacts
Contact: Meredith A Achey, BM 5852766825 connect@parkinson.org

Locations
United States, Illinois
Northwestern University Not yet recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Cindy Zadikoff, MD         
United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Meredith A Achey, BM    585-276-6825    connect@parkinson.org   
Principal Investigator: Irene Richard, MD         
Sub-Investigator: Rachel Biemiller, MD         
Sub-Investigator: Kevin M Biglan, MD, MPH         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Principal Investigator: Julie Carter, RN, MS, ANP         
United States, Washington
Northwest Neurological, PLLC Not yet recruiting
Spokane, Washington, United States, 99202
Principal Investigator: Jason L Aldred, MD         
Sponsors and Collaborators
University of Rochester
Patient Centered Outcome Research Institute
National Parkinson Foundation
Investigators
Principal Investigator: E. Ray Dorsey, MD, MBA University of Rochester
  More Information

Additional Information:
Publications:
Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT02038959     History of Changes
Other Study ID Numbers: AD-12-11-4701
Study First Received: January 8, 2014
Last Updated: July 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Parkinson disease
Parkinson's
Parkinson's disease
telemedicine
virtual visits
video calls
video conferencing
virtual house calls

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 July 22, 2014