Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-24 @ 3:15 PM
Study NCT ID:
NCT02447094
Status:
UNKNOWN
Last Update Posted:
2016-02-09
First Post:
2015-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life After Stroke Using a Telemedicine-based Stroke Network
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D007511', 'term': 'Ischemia'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010959', 'term': 'Tissue Plasminogen Activator'}], 'ancestors': [{'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D010960', 'term': 'Plasminogen Activators'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'lastUpdateSubmitDate': '2016-02-08', 'studyFirstSubmitDate': '2015-05-09', 'studyFirstSubmitQcDate': '2015-05-13', 'lastUpdatePostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HRQoL', 'timeFrame': '6 months', 'description': 'Health Related Quality of Life'}], 'secondaryOutcomes': [{'measure': 'mRS', 'timeFrame': '6 months', 'description': 'Modified Rankin Scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ischemic', 'tPA', 'tele-medicine', 'robot', 'tele-stroke'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'To study the effect of a telemedicine model of stroke care on patient-based outcomes.', 'detailedDescription': 'Approximately 750,000 patients suffer from ischemic stroke (AIS) annually in the United States. AIS is a a leading cause of long-term disability and the third-leading cause of mortality. Effective therapies exist to ameliorate the disability associated with AIS, but implementation of these therapies is time-sensitive. Currently, there is a shortage in health care professionals with expertise in the treatment of stroke and such expertise tends to be concentrated in large community-based or academic medical centers. To respond to this shortage, stroke networks are being organized in a "hub-and-spoke" model to facilitate the rapid delivery of time-sensitive interventions such as intravenous (i.v.) tissue plasminogen activator (tPA) or rapid evaluation for AIS. Some networks are also using telemedicine to facilitate this approach and bring the needed expertise via robotic tele-presence (RTP). Though the accuracy of stroke diagnosis and i.v. tPA utilization may be higher in RTP based networks, the impact of this model on patient\'s outcomes has been difficult to elucidate. To this end, meaningful validated outcome assessments are crucial to understand the impact of stroke interventions including telemedicine or RTP based networks. The objective of this study is to translate evidence-based practice of healthcare, patient-centered outcome assessments, and patient-family perceptions of delivery of care into meaningful data. This will aid in the validation of the role of interventions such as "hub-and-spoke" RTP based models in stroke care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This research will be performed only in AIS patients who are routinely admitted to our "Hub" and participating "spoke" centers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with suspected acute ischemic stroke (AIS)\n* Age \\>17 years\n\nExclusion Criteria:\n\n* Hemorrhagic strokes (ICH or SAH)\n* Transient ischemic attacks (TIA)\n* Trauma\n* Inability to obtain informed consent\n* Participation in another study'}, 'identificationModule': {'nctId': 'NCT02447094', 'acronym': 'STROKE TeleQOL', 'briefTitle': 'Quality of Life After Stroke Using a Telemedicine-based Stroke Network', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Assessing the Impact of Care in A Telemedicine-based Stroke Network Using Patient-Centered Health Related Quality of Life Outcomes', 'orgStudyIdInfo': {'id': '15D.044'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Exposed', 'description': 'AIS patients evaluated through RTP and who receive i.v. tPA', 'interventionNames': ['Drug: Alteplase']}, {'label': 'Un-exposed', 'description': 'AIS patients evaluated through RTP and who do not receive i.v. tPA'}], 'interventions': [{'name': 'Alteplase', 'type': 'DRUG', 'otherNames': ['Recombinant tissue plasminogen activator (tPA)'], 'description': 'Intravenous (i.v.) tPA per the standard of care', 'armGroupLabels': ['Exposed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'James P Murphy', 'role': 'CONTACT', 'email': 'James.P.Murphy@jefferson.edu', 'phone': '215-503-5739'}, {'name': 'Fred Rincon, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Neurology and Neurosurgery', 'investigatorFullName': 'Fred Rincon', 'investigatorAffiliation': 'Thomas Jefferson University'}}}}