Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-31 @ 11:06 PM
Study NCT ID:
NCT00668551
Status:
COMPLETED
Last Update Posted:
2009-04-13
First Post:
2008-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Randomized Controlled Trial of Telemedicine for Individuals With Parkinson Disease in a Rural Population
Sponsor:
University of Rochester
Organization:
Study Overview
Official Title:
Pilot Randomized Controlled Trial of Telemedicine for Individuals With Parkinson Disease in a Rural Population
Status:
COMPLETED
Status Verified Date:
2009-04
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:
Tele-PD
Brief Summary:
To eliminate barriers (such as travel and cost) to specialized Parkinson disease (PD) care, two movement disorder specialists at the University of Rochester will be providing telemedicine visits for patients with PD who reside in the Presbyterian Home for Central New York in New Hartford, NY, or for individuals who participate in the local support group that meets at the nursing home. Participants will attend 3 telemedicine visits at the Presbyterian Home over the course of 6 months.
We hypothesize that this telemedicine model will in time improve access to care and hence the quality of life and quality of care of individuals with PD.
We hypothesize that this telemedicine model will in time improve access to care and hence the quality of life and quality of care of individuals with PD.
Detailed Description:
Study participants are recruited from the Presbyterian Home and from the Central New York Parkinson Support Group. Anyone interested will attend a screening and baseline visit at the Presbyterian Home, where they will receive baseline surveys and a motor assessment. Eligible participants will be randomized to receive either telemedicine or standard of care.
Each telemedicine visit (Month 1, Month 3, Month 6) will take place in a 1:1 fashion between the study participant and the physician investigator - one of two movement disorder specialists from the University of Rochester - via televideo linkage, and will last approximately 30-60 minutes. The study participant will be observed by the physician investigator and she/he will be accompanied by a Presbyterian Home staff member to ensure safety throughout the telemedicine visit. The visit will be structured much the same as a standard clinical visit and will include:
* Study participant's update on his or her clinical condition
* Review of current medications, which will be provided in advance of the visit
* Review and update of medical and social histories
* Vital signs, including weight (provided by the Presbyterian Home staff)
* Pertinent neurological exam, including a modified motor examination led by physician investigator
* Assessment of current clinical state
* Dictated recommendations including a letter to the attending physician for ongoing clinical care, including changes to the PD medications
Participants assigned to the control group will receive their care as routinely scheduled with their own primary care physician and/or neurologist.
Staff members from the University of Rochester will return to the Presbyterian Home within one month of the six month study to complete final assessments with all study participants. These will include:
* Reportable events form
* Health care events form
* Quality of life and healthcare evaluation surveys
* Continuation of care survey
* 1:1 interviews
* Telemedicine focus groups
Each telemedicine visit (Month 1, Month 3, Month 6) will take place in a 1:1 fashion between the study participant and the physician investigator - one of two movement disorder specialists from the University of Rochester - via televideo linkage, and will last approximately 30-60 minutes. The study participant will be observed by the physician investigator and she/he will be accompanied by a Presbyterian Home staff member to ensure safety throughout the telemedicine visit. The visit will be structured much the same as a standard clinical visit and will include:
* Study participant's update on his or her clinical condition
* Review of current medications, which will be provided in advance of the visit
* Review and update of medical and social histories
* Vital signs, including weight (provided by the Presbyterian Home staff)
* Pertinent neurological exam, including a modified motor examination led by physician investigator
* Assessment of current clinical state
* Dictated recommendations including a letter to the attending physician for ongoing clinical care, including changes to the PD medications
Participants assigned to the control group will receive their care as routinely scheduled with their own primary care physician and/or neurologist.
Staff members from the University of Rochester will return to the Presbyterian Home within one month of the six month study to complete final assessments with all study participants. These will include:
* Reportable events form
* Health care events form
* Quality of life and healthcare evaluation surveys
* Continuation of care survey
* 1:1 interviews
* Telemedicine focus groups
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?: