Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2025-12-29 @ 4:51 PM
Study NCT ID:
NCT01476306
Status:
COMPLETED
Last Update Posted:
2017-12-11
First Post:
2011-11-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Providing Specialty Care to Individuals With Parkinsonism Directly in Their Homes Via Web-based Video Conferencing- A Comparative Effectiveness Study
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
Providing Specialty Care to Individuals With Parkinsonism Directly in Their Homes Via Web-based Video Conferencing- A Comparative Effectiveness Study
Status:
COMPLETED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TELEMED-PD
Brief Summary:
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: