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SPECIFIC AIM: The specific aims of this study are to evaluate the long term outcomes of patients previously enrolled in the STRokE DOC ("STRokE DOC Trial (NCT00283868)") telemedicine clinical trial.
AIM 1: Aim 1 is a non- randomized, retrospective, data collection study assessing long term patient outcomes of patients previously enrolled in a telemedicine vs. telephone clinical trial (STRokE DOC Trial ("STRokE DOC Trial (NCT00283868)"); now completed). STRokE DOC-LTO will evaluate, (only for those patients previously enrolled in the original telemedicine vs. telephone clinical research trial), the long term patient outcomes; comparing telemedicine versus telephone-only consultations.
SPECIFIC AIM: The specific aims of this study are to evaluate the long term outcomes of patients previously enrolled in the STRokE DOC ("STRokE DOC Trial (NCT00283868)") telemedicine clinical trial.
AIM 1: Aim 1 is a non- randomized, retrospective, data collection study assessing long term patient outcomes of patients previously enrolled in a telemedicine vs. telephone clinical trial (STRokE DOC Trial ("STRokE DOC Trial (NCT00283868)"); now completed). STRokE DOC-LTO will evaluate, (only for those patients previously enrolled in the original telemedicine vs. telephone clinical research trial), the long term patient outcomes; comparing telemedicine versus telephone-only consultations.
Specific Protocol Information: The protocol will contact these patients by telephone. One of 5 Stroke Center team members will contact the patient, using strict telephone scripted language (approved by the IRB) and ask questions regarding
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemedicine | Telemedicine evaluated patients | ||
| Telephone | Telephone evaluated patients |
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| Measure | Description | Time Frame |
|---|---|---|
| Functional Outcome (mRS(0-1)) at 6 Months After Index Event. The mRS is the Modified Rankin Scale That Measures Patient's Functional Level of Activity. The Scale is a 6 Point Scale With 0 Score Being Normal and 6 Score Being Death. | Functional Outcome (mRS(0-1)) at 6 months after index event. The mRS is the modified Rankin Scale that measures patient's functional level of activity. The scale is a 6 point scale with 0 score being normal and 6 score being death. Listed below is the number of participants in each group with Functional Outcome (mRS(0-1)). | Patients were all assessed at a single time point (July 2009) for retrospective reporting of how they were at 6 months since initial event (Primary endpoint). The average time per participant relative to the study entry time in concrete units is 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent Stroke | Assessing amount of patients that had recurrent stroke by 6 months (patients that retrospectively reporting having had a stroke from 0-6 months after their index event) | Patients were all assessed at a single time point (July 2009) for retrospective reporting of how they were at 6 months since initial event (Primary endpoint). The average time per participant relative to the study entry time in concrete units is 6 months |
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Inclusion Criteria are:
Exclusion criteria are:
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Inclusion Criteria are:
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| Name | Affiliation | Role |
|---|---|---|
| Brett C Meyer, MD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD | San Diego | California | 92103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18676180 | Background | Meyer BC, Raman R, Hemmen T, Obler R, Zivin JA, Rao R, Thomas RG, Lyden PD. Efficacy of site-independent telemedicine in the STRokE DOC trial: a randomised, blinded, prospective study. Lancet Neurol. 2008 Sep;7(9):787-95. doi: 10.1016/S1474-4422(08)70171-6. | |
| 20851629 | Derived | Meyer BC, Raman R, Ernstrom K, Tafreshi GM, Huisa B, Stemer AB, Hemmen TM. Assessment of long-term outcomes for the STRokE DOC telemedicine trial. J Stroke Cerebrovasc Dis. 2012 May;21(4):259-64. doi: 10.1016/j.jstrokecerebrovasdis.2010.08.004. Epub 2010 Sep 19. |
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Observational study. Patient contact via telephone. Patients were all contacted at a single time point (irrespective of time since original trial enrollment) and were asked structured questions regarding their level of function at 3 time points (6 months after original event, 12 months after original event, and current time point).
Patients were assessed in July 2009. Patients were all contacted at a single time point (irrespective of time since original trial enrollment) and were asked structured questions regarding their level of function at 3 time points (6 months after original event, 12 months after original event, and current time point).
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| ID | Title | Description |
|---|---|---|
| FG000 | Telemedicine | Telemedicine evaluated patients- The definition of telemedicine for this trial was the use of 2 way video and 2 way audio videoconferencing and also the use of digital access to radiology image review. Telephone use is not considered telemedicine for the purposes of this trial. |
| FG001 | Telephone | Telephone evaluated patients |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Telemedicine | Telemedicine evaluated patients- The definition of telemedicine for this trial was the use of 2 way video and 2 way audio videoconferencing and also the use of digital access to radiology image review. Telephone use is not considered telemedicine for the purposes of this trial. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Functional Outcome (mRS(0-1)) at 6 Months After Index Event. The mRS is the Modified Rankin Scale That Measures Patient's Functional Level of Activity. The Scale is a 6 Point Scale With 0 Score Being Normal and 6 Score Being Death. | Functional Outcome (mRS(0-1)) at 6 months after index event. The mRS is the modified Rankin Scale that measures patient's functional level of activity. The scale is a 6 point scale with 0 score being normal and 6 score being death. Listed below is the number of participants in each group with Functional Outcome (mRS(0-1)). | NUMBER OF PARTICIPANTS WAS DETERMINED BASED ON PER PROTOCOL NUMBER OF PATIENT ABLE TO BE CONTACTED VIA TELEPHONE | Posted | Number | participants | Patients were all assessed at a single time point (July 2009) for retrospective reporting of how they were at 6 months since initial event (Primary endpoint). The average time per participant relative to the study entry time in concrete units is 6 months |
|
Observational Trial- Adverse events were not collected/ assessed in this observational study
Observational Trial- Adverse events were not collected/ assessed in this observational study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Telemedicine | Telemedicine evaluated patients- The definition of telemedicine for this trial was the use of 2 way video and 2 way audio videoconferencing and also the use of digital access to radiology image review. Telephone use is not considered telemedicine for the purposes of this trial. |
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This is an observational trial where patients were contacted by telephone for data collection only. No adverse event information was collected.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Brett Meyer | University of California San Diego | 619-543-7760 | bcmeyer@ucsd.edu |
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| Recurrent Stroke | Assessing amount of patients that had recurrent stroke by 12 months (patients that retrospectively reporting having had a stroke from 6-12 months after their index event) | Patients were all assessed at a single time point (July 2009) for retrospective reporting of how they were at 12 months since initial event (2ndary endpoint). The average time per participant relative to the study entry time in units is 12 months |
| Functional Outcome (mRS(0-1)) at 12 Months After Index Event. The mRS is the Modified Rankin Scale That Measures Patient's Functional Level of Activity. The Scale is a 6 Point Scale With 0 Score Being Normal and 6 Score Being Death. | Functional Outcome (mRS(0-1)) at 12 months after index event. The mRS is the modified Rankin Scale that measures patient's functional level of activity. The scale is a 6 point scale with 0 score being normal and 6 score being death. Listed below is the number of participants in each group with Functional Outcome (mRS(0-1)). | Patients were all assessed at a single time point (July 2009) for retrospective reporting of how they were at 12 months since initial event (2ndary endpoint). The average time per participant relative to the study entry time in units is 12 months |
| Telephone |
Telephone evaluated patients |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Functional Outcome (mRS(0-1)) at 6 months after index event in the telemedicine group |
| OG001 | Telephone | Functional Outcome (mRS(0-1)) at 6 months after index event in the telephone group |
|
|
| Secondary | Recurrent Stroke | Assessing amount of patients that had recurrent stroke by 6 months (patients that retrospectively reporting having had a stroke from 0-6 months after their index event) | NUMBER OF PARTICIPANTS WAS DETERMINED BASED ON PER PROTOCOL NUMBER OF PATIENT ABLE TO BE CONTACTED VIA TELEPHONE | Posted | Number | participants | Patients were all assessed at a single time point (July 2009) for retrospective reporting of how they were at 6 months since initial event (Primary endpoint). The average time per participant relative to the study entry time in concrete units is 6 months |
|
|
|
| Secondary | Recurrent Stroke | Assessing amount of patients that had recurrent stroke by 12 months (patients that retrospectively reporting having had a stroke from 6-12 months after their index event) | NUMBER OF PARTICIPANTS WAS DETERMINED BASED ON PER PROTOCOL NUMBER OF PATIENT ABLE TO BE CONTACTED VIA TELEPHONE | Posted | Number | participants | Patients were all assessed at a single time point (July 2009) for retrospective reporting of how they were at 12 months since initial event (2ndary endpoint). The average time per participant relative to the study entry time in units is 12 months |
|
|
|
| Secondary | Functional Outcome (mRS(0-1)) at 12 Months After Index Event. The mRS is the Modified Rankin Scale That Measures Patient's Functional Level of Activity. The Scale is a 6 Point Scale With 0 Score Being Normal and 6 Score Being Death. | Functional Outcome (mRS(0-1)) at 12 months after index event. The mRS is the modified Rankin Scale that measures patient's functional level of activity. The scale is a 6 point scale with 0 score being normal and 6 score being death. Listed below is the number of participants in each group with Functional Outcome (mRS(0-1)). | NUMBER OF PARTICIPANTS WAS DETERMINED BASED ON PER PROTOCOL NUMBER OF PATIENT ABLE TO BE CONTACTED VIA TELEPHONE | Posted | Number | participants | Patients were all assessed at a single time point (July 2009) for retrospective reporting of how they were at 12 months since initial event (2ndary endpoint). The average time per participant relative to the study entry time in units is 12 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Telephone | Telephone evaluated patients | 0 | 0 | 0 | 0 |
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