Pilot Randomized Controlled Trial of Telemedicine for Individuals With Parkinson Disease in a Rural Population (Tele-PD)
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| First Received Date ICMJE | April 25, 2008 | ||||||||
| Last Updated Date | April 10, 2009 | ||||||||
| Start Date ICMJE | April 2008 | ||||||||
| Primary Completion Date | November 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
The feasibility of telemedicine, based on participant ability to complete 75% or more of the trial visits. [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00668551 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | |||||||||
| Original Other Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Pilot Randomized Controlled Trial of Telemedicine for Individuals With Parkinson Disease in a Rural Population | ||||||||
| Official Title ICMJE | Pilot Randomized Controlled Trial of Telemedicine for Individuals With Parkinson Disease in a Rural Population | ||||||||
| 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. |
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| 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:
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:
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Biospecimen | |||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Study participants will be recruited from the Presbyterian Home Parkinson disease nursing home, assisted living, independent living, and adult day care populations, as well as the local PD support group that meets monthly at the Presbyterian Home. |
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| Condition ICMJE | Parkinson Disease | ||||||||
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| Study Group/Cohort (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 14 | ||||||||
| Completion Date | November 2008 | ||||||||
| Primary Completion Date | November 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00668551 | ||||||||
| Other Study ID Numbers ICMJE | RSRB00022923 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | E. Ray Dorsey, MD, MBA, University of Rochester | ||||||||
| Study Sponsor ICMJE | University of Rochester | ||||||||
| Collaborators ICMJE | Presbyterian Home for Central New York, Inc. | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Rochester | ||||||||
| Verification Date | April 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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