Stroke Team Remote Evaluation Using a Digital Observation Camera- Long Term Outcomes(STRokE DOC-LTO)
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Purpose
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.
| Condition |
|---|
|
Telemedicine Evaluation vs Telephone Evaluation |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | An Observational Study to Evaluate the Long Term Outcomes of Patients Previously Enrolled in the STRokE DOC ("STRokE DOC Trial (NCT00283868)") Telemedicine Clinical Trial. |
- 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. [ Time Frame: 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 ] [ Designated as safety issue: No ]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)).
- Recurrent Stroke [ Time Frame: 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 ] [ Designated as safety issue: No ]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)
- Recurrent Stroke [ Time Frame: 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 ] [ Designated as safety issue: No ]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)
- 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. [ Time Frame: 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 ] [ Designated as safety issue: No ]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)).
| Enrollment: | 75 |
| Study Start Date: | June 2009 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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Telemedicine
Telemedicine evaluated patients
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|
Telephone
Telephone evaluated patients
|
Detailed Description:
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
- current functional status
- death
- Hemorrhage
- Recurrent Stroke
- Disposition for 3 time periods (6 months after index event, 12 months after index event, and "current" time of contact.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria are:
- Male or female subjects, age > 18 years.
- Prior enrollment into the STRokE DOC ("STRokE DOC Trial (NCT00283868)") clinical research trial.
Inclusion Criteria are:
- Male or female subjects, age > 18 years.
- Prior enrollment into the STRokE DOC ("STRokE DOC Trial (NCT00283868)") clinical research trial.
Exclusion criteria are:
- Male or female subjects, age < 18 years.
- Patients not previously enrolled into the STRokE DOC ("STRokE DOC Trial (NCT00283868)") clinical research trial.
Contacts and Locations| United States, California | |
| UCSD | |
| San Diego, California, United States, 92103 | |
| Principal Investigator: | Brett C Meyer, MD | University of California, San Diego |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Brett Meyer, MD, University of California, San Diego |
| ClinicalTrials.gov Identifier: | NCT00936455 History of Changes |
| Other Study ID Numbers: | STRokE DOC-LTO |
| Study First Received: | July 9, 2009 |
| Results First Received: | August 29, 2011 |
| Last Updated: | April 24, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of California, San Diego:
|
telemedicine telephone outcomes |
Additional relevant MeSH terms:
|
Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013