Trial Outcomes & Findings for Stroke Team Remote Evaluation Using a Digital Observation Camera- Long Term Outcomes(STRokE DOC-LTO) (NCT NCT00936455)

Results Overview

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)).

Recruitment status

COMPLETED

Target enrollment

75 participants

Primary outcome timeframe

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

Results posted on

2012-04-30

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).

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).

Participant milestones

Participant milestones
Measure	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.	Telephone Telephone evaluated patients
Overall Study STARTED	37	38
Overall Study COMPLETED	37	38
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Telemedicine n=37 Participants 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.	Telephone n=38 Participants Telephone evaluated patients	Total n=75 Participants Total of all reporting groups
Age Continuous	68 years STANDARD_DEVIATION 13 • n=5 Participants	67 years STANDARD_DEVIATION 13 • n=7 Participants	67 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	22 Participants n=7 Participants	41 Participants n=5 Participants
Region of Enrollment United States	37 participants n=5 Participants	38 participants n=7 Participants	75 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Population: NUMBER OF PARTICIPANTS WAS DETERMINED BASED ON PER PROTOCOL NUMBER OF PATIENT ABLE TO BE CONTACTED VIA 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. Listed below is the number of participants in each group with Functional Outcome (mRS(0-1)).

Outcome measures

Outcome measures
Measure	Telemedicine n=37 Participants Functional Outcome (mRS(0-1)) at 6 months after index event in the telemedicine group	Telephone n=38 Participants Functional Outcome (mRS(0-1)) at 6 months after index event in the telephone group
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 participants	17 participants

SECONDARY outcome

Timeframe: 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

Population: NUMBER OF PARTICIPANTS WAS DETERMINED BASED ON PER PROTOCOL NUMBER OF PATIENT ABLE TO BE CONTACTED VIA TELEPHONE

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)

Outcome measures

Outcome measures
Measure	Telemedicine n=37 Participants Functional Outcome (mRS(0-1)) at 6 months after index event in the telemedicine group	Telephone n=38 Participants Functional Outcome (mRS(0-1)) at 6 months after index event in the telephone group
Recurrent Stroke	1 participants	2 participants

SECONDARY outcome

Timeframe: 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

Population: NUMBER OF PARTICIPANTS WAS DETERMINED BASED ON PER PROTOCOL NUMBER OF PATIENT ABLE TO BE CONTACTED VIA TELEPHONE

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)

Outcome measures

Outcome measures
Measure	Telemedicine n=37 Participants Functional Outcome (mRS(0-1)) at 6 months after index event in the telemedicine group	Telephone n=38 Participants Functional Outcome (mRS(0-1)) at 6 months after index event in the telephone group
Recurrent Stroke	0 participants	1 participants

SECONDARY outcome

Timeframe: 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

Population: NUMBER OF PARTICIPANTS WAS DETERMINED BASED ON PER PROTOCOL NUMBER OF PATIENT ABLE TO BE CONTACTED VIA 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. Listed below is the number of participants in each group with Functional Outcome (mRS(0-1)).

Outcome measures

Outcome measures
Measure	Telemedicine n=37 Participants Functional Outcome (mRS(0-1)) at 6 months after index event in the telemedicine group	Telephone n=38 Participants Functional Outcome (mRS(0-1)) at 6 months after index event in the telephone group
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 participants	1 participants

Adverse Events

Telemedicine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Telephone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Brett Meyer

University of California San Diego

Phone: 619-543-7760

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place