- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT00936455
Stroke Team Remote Evaluation Using a Digital Observation Camera- Long Term Outcomes(STRokE DOC-LTO) (STRokE DOC-LTO)
An Observational Study to Evaluate the Long Term Outcomes of Patients Previously Enrolled in the STRokE DOC ("STRokE DOC Trial (NCT00283868)") Telemedicine Clinical Trial.
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.
Обзор исследования
Статус
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
-
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California
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San Diego, California, Соединенные Штаты, 92103
- UCSD
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Inclusion Criteria are:
- Male or female subjects, age > 18 years.
- Prior enrollment into the STRokE DOC ("STRokE DOC Trial (NCT00283868)") clinical research trial.
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
---|
Telemedicine
Telemedicine evaluated patients
|
Telephone
Telephone evaluated patients
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
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.
Временное ограничение: 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
|
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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Recurrent Stroke
Временное ограничение: 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
|
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
|
Recurrent Stroke
Временное ограничение: 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
|
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.
Временное ограничение: 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.
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
|
Соавторы и исследователи
Следователи
- Главный следователь: Brett C Meyer, MD, University of California, San Diego
Публикации и полезные ссылки
Общие публикации
- 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.
- 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.
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- STRokE DOC-LTO
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