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Stroke Team Remote Evaluation Using a Digital Observation Camera- Long Term Outcomes(STRokE DOC-LTO) (STRokE DOC-LTO)

24 april 2012 bijgewerkt door: Brett Meyer, University of California, San Diego

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

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

  1. current functional status
  2. death
  3. Hemorrhage
  4. Recurrent Stroke
  5. Disposition for 3 time periods (6 months after index event, 12 months after index event, and "current" time of contact.

Studietype

Observationeel

Inschrijving (Werkelijk)

75

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • California
      • San Diego, California, Verenigde Staten, 92103
        • UCSD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 90 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

Inclusion Criteria are:

  1. Male or female subjects, age > 18 years.
  2. Prior enrollment into the STRokE DOC ("STRokE DOC Trial (NCT00283868)") clinical research trial.

Beschrijving

Inclusion Criteria are:

  1. Male or female subjects, age > 18 years.
  2. Prior enrollment into the STRokE DOC ("STRokE DOC Trial (NCT00283868)") clinical research trial.

Exclusion criteria are:

  1. Male or female subjects, age < 18 years.
  2. Patients not previously enrolled into the STRokE DOC ("STRokE DOC Trial (NCT00283868)") clinical research trial.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Telemedicine
Telemedicine evaluated patients
Telephone
Telephone evaluated patients

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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.
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Recurrent Stroke
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of California, San Diego

Onderzoekers

  • Hoofdonderzoeker: Brett C Meyer, MD, University of California, San Diego

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juni 2009

Primaire voltooiing (Werkelijk)

1 juni 2010

Studie voltooiing (Werkelijk)

1 augustus 2010

Studieregistratiedata

Eerst ingediend

9 juli 2009

Eerst ingediend dat voldeed aan de QC-criteria

9 juli 2009

Eerst geplaatst (Schatting)

10 juli 2009

Updates van studierecords

Laatste update geplaatst (Schatting)

30 april 2012

Laatste update ingediend die voldeed aan QC-criteria

24 april 2012

Laatst geverifieerd

1 april 2012

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • STRokE DOC-LTO

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