This trial is active, not recruiting.

Condition parkinson disease
Treatment virtual visits
Sponsor University of Rochester
Collaborator Patient-Centered Outcomes Research Institute
Start date March 2014
End date July 2016
Trial size 480 participants
Trial identifier NCT02038959, AD-12-11-4701


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose health services research
(No Intervention)
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.
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.
virtual visits Telemedicine
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).
(No Intervention)
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).

Primary Outcomes

Feasibility of Virtual Visits for Parkinson Disease
time frame: One year
Efficacy of care provided via virtual visits
time frame: One year

Secondary Outcomes

Overall Quality of Life
time frame: One year
Patient Global Impression of Change
time frame: One year
time frame: One year
Parkinson disease severity
time frame: One year
Quality of Care
time frame: One year
Value to patients and care partners
time frame: One year
Care partner burden
time frame: One year

Eligibility Criteria

Male or female participants at least 30 years old.

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.

Additional Information

Official title Using Technology to Deliver Multi-disciplinary Care to Individuals With Parkinson Disease in Their Homes: the Connect.Parkinson Study
Principal investigator E. Ray Dorsey, MD, MBA
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University of Rochester.