CompletedNCT00936455STRokE DOC-LTOUpdated Apr 30, 2012Results posted

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

An observational study in Telemedicine Evaluation vs Telephone Evaluation, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2012-04-30.

Sponsored by University of California, San Diego · Observational

Study type: Observational
Model: Cohort
Time perspective: Retrospective
Enrollment: 75
Ages: 18 Years to 90 Years
Sex: All

Study summary

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.

Read the 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.

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.

Conditions studied

Telemedicine Evaluation vs Telephone Evaluation

Browse trials for

Stroke 7,286

Keywords

telemedicine
telephone
outcomes

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 75 is below the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 90 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

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

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

Exclusion criteria

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.

Study design

Observational model: Cohort
Time perspective: Retrospective
Enrollment: 75 participants (actual)

Groups and cohorts

Telemedicine
Telemedicine evaluated patients
Telephone
Telephone evaluated patients

What researchers measure

Primary outcomes

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)).
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

Secondary outcomes

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)
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
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)
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
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)).
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

Results

Posted Apr 24, 2012

Limitations and caveats

This is an observational trial where patients were contacted by telephone for data collection only. No adverse event information was collected.

Participant flow

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).

Participant flow — Overall Study
Milestone	Telemedicine	Telephone
Started	37	38
Completed	37	38
Not completed	0	0

Outcome measures

PrimaryFunctional 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)).

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
Reported as:: Number · participants

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.
participants	Telemedicine	Telephone
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.	12	17

SecondaryRecurrent 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)

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
Reported as:: Number · participants

Recurrent Stroke
participants	Telemedicine	Telephone
Recurrent Stroke	1	2

SecondaryRecurrent 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)

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
Reported as:: Number · participants

Recurrent Stroke
participants	Telemedicine	Telephone
Recurrent Stroke	0	1

SecondaryFunctional 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)).

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
Reported as:: Number · participants

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.
participants	Telemedicine	Telephone
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.	0	1

Adverse events

Collected over Observational Trial- Adverse events were not collected/ assessed in this observational study. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Telemedicine	—	—	—
Telephone	—	—	—

Baseline characteristics

Age Continuous
Age Continuous(years)	Telemedicine	Telephone	Total
Mean	68 ± 13	67 ± 13	67 ± 13

Sex: Female, Male
Sex: Female, Male(Participants)	Telemedicine	Telephone	Total
Female	18	16	34
Male	19	22	41

Region of Enrollment
Region of Enrollment(participants)	Telemedicine	Telephone	Total
United States	37	38	75

Study locations

1 site

UCSD
San Diego, California 92103, United States

References and documents

Publications

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. PubMed 18676180 ↗
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. PubMed 20851629 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 30, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00936455
Lead sponsor: University of California, San Diego
Responsible party: Brett Meyer (MD, University of California, San Diego) — Principal investigator
First posted: Jul 10, 2009
Start date: Jun 2009
Primary completion: Jun 2010
Completion: Aug 2010
Results posted: Apr 24, 2012
Last update: Apr 30, 2012

Study contacts

Brett C Meyer, MD

principal investigator · University of California, San Diego

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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