Providing Specialty Care to Individuals With Parkinsonism Directly in Their Homes Via Web-based Video Conferencing— A Comparative Effectiveness Study (TELEMED-PD)
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|ClinicalTrials.gov Identifier: NCT01476306|
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : December 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Other: Telemedicine Other: Usual care||Not Applicable|
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.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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|
|Actual Study Start Date :||November 2011|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
|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||
Patient will receive care using HIPAA-compliant web-based videoconferencing rather than their usual in-patient care.
- Feasibility [ Time Frame: 7 months ]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
- Clinical Benefits [ Time Frame: 7 months ]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 ]Travel, time, facilities fees
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01476306
|United States, Maryland|
|Johns Hopkins Medical Institutes|
|Baltimore, Maryland, United States, 21287|