Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-10 @ 2:03 PM
Study NCT ID:
NCT00668551
Status:
COMPLETED
Last Update Posted:
2009-04-13
First Post:
2008-04-25
Is 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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-10', 'studyFirstSubmitDate': '2008-04-25', 'studyFirstSubmitQcDate': '2008-04-25', 'lastUpdatePostDateStruct': {'date': '2009-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The feasibility of telemedicine, based on participant ability to complete 75% or more of the trial visits.', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': "Parkinson's Disease Questionnaire-39 (PDQ-39)", 'timeFrame': '6 months'}, {'measure': 'EuroQol (EQ-5D)', 'timeFrame': '6 months'}, {'measure': 'Geriatric Depression Scale Short Form (GDS-15)', 'timeFrame': '6 months'}, {'measure': "Modified Group Health Association of America's Consumer Satisfaction Survey (GHAA)", 'timeFrame': '6 months'}, {'measure': 'Qualitative assessment, including a telemedicine focus group and 1:1 interviews with study participants', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Parkinson disease', 'Telemedicine'], 'conditions': ['Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '8341308', 'type': 'BACKGROUND', 'citation': "Hubble JP, Pahwa R, Michalek DK, Thomas C, Koller WC. Interactive video conferencing: a means of providing interim care to Parkinson's disease patients. Mov Disord. 1993 Jul;8(3):380-2. doi: 10.1002/mds.870080326."}, {'pmid': '17260340', 'type': 'BACKGROUND', 'citation': "Cheng EM, Swarztrauber K, Siderowf AD, Eisa MS, Lee M, Vassar S, Jacob E, Vickrey BG. Association of specialist involvement and quality of care for Parkinson's disease. Mov Disord. 2007 Mar 15;22(4):515-22. doi: 10.1002/mds.21311."}, {'pmid': '15867035', 'type': 'BACKGROUND', 'citation': 'McConnochie KM, Wood NE, Kitzman HJ, Herendeen NE, Roy J, Roghmann KJ. Telemedicine reduces absence resulting from illness in urban child care: evaluation of an innovation. Pediatrics. 2005 May;115(5):1273-82. doi: 10.1542/peds.2004-0335.'}, {'pmid': '16438773', 'type': 'BACKGROUND', 'citation': "Samii A, Ryan-Dykes P, Tsukuda RA, Zink C, Franks R, Nichol WP. Telemedicine for delivery of health care in Parkinson's disease. J Telemed Telecare. 2006;12(1):16-8. doi: 10.1258/135763306775321371."}]}, 'descriptionModule': {'briefSummary': '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.\n\nWe 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.', 'detailedDescription': "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.\n\nEach 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:\n\n* Study participant's update on his or her clinical condition\n* Review of current medications, which will be provided in advance of the visit\n* Review and update of medical and social histories\n* Vital signs, including weight (provided by the Presbyterian Home staff)\n* Pertinent neurological exam, including a modified motor examination led by physician investigator\n* Assessment of current clinical state\n* Dictated recommendations including a letter to the attending physician for ongoing clinical care, including changes to the PD medications\n\nParticipants assigned to the control group will receive their care as routinely scheduled with their own primary care physician and/or neurologist.\n\nStaff 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:\n\n* Reportable events form\n* Health care events form\n* Quality of life and healthcare evaluation surveys\n* Continuation of care survey\n* 1:1 interviews\n* Telemedicine focus groups"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Willing and able to provide informed consent\n* Age 30 years old or older\n* Clinical diagnosis of idiopathic Parkinson's disease as determined by having two of the four cardinal features of PD (rest tremor, bradykinesia, cogwheel rigidity, and gait instability) and no better alternative explanation for the etiology of the symptoms\n* Able to converse in English\n* Willing and able to complete study requirements\n\nExclusion Criteria:\n\n* Any neurological, medical, or psychiatric condition that would preclude the patient having the ability to provide informed consent or to participate in the telemedicine visit."}, 'identificationModule': {'nctId': 'NCT00668551', 'acronym': 'Tele-PD', 'briefTitle': 'Pilot Randomized Controlled Trial of Telemedicine for Individuals With Parkinson Disease in a Rural Population', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Pilot Randomized Controlled Trial of Telemedicine for Individuals With Parkinson Disease in a Rural Population', 'orgStudyIdInfo': {'id': 'RSRB00022923'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Telemedicine care'}, {'label': '2', 'description': 'Standard of care'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13413', 'city': 'New Hartford', 'state': 'New York', 'country': 'United States', 'facility': 'Presbyterian Home for Central New York, Inc.', 'geoPoint': {'lat': 43.0734, 'lon': -75.28767}}], 'overallOfficials': [{'name': 'E. Ray Dorsey, MD, MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}, {'name': 'Kevin Biglan, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'Presbyterian Homes & Services', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'E. Ray Dorsey, MD, MBA', 'oldOrganization': 'University of Rochester'}}}}