Telemedicine Evaluation vs Telephone Evaluation
Conditions
Keywords
telemedicine, telephone, outcomes
Brief 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.
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 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.
Interventions
None listed
Sponsors
University of California, San Diego
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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)). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrent Stroke | 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) |
| 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. | 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)). |
Countries
United States
Participant flow
Recruitment details
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).
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 37 |
| Telephone Telephone evaluated patients | 38 |
| Total | 75 |
Baseline characteristics
| Characteristic | Telemedicine | Telephone | Total |
|---|---|---|---|
| Age Continuous | 68 years STANDARD_DEVIATION 13 | 67 years STANDARD_DEVIATION 13 | 67 years STANDARD_DEVIATION 13 |
| Region of Enrollment United States | 37 participants | 38 participants | 75 participants |
| Sex: Female, Male Female | 18 Participants | 16 Participants | 34 Participants |
| Sex: Female, Male Male | 19 Participants | 22 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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
Population: NUMBER OF PARTICIPANTS WAS DETERMINED BASED ON PER PROTOCOL NUMBER OF PATIENT ABLE TO BE CONTACTED VIA TELEPHONE
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telemedicine | 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 |
| 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. | 17 participants |
Secondary
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
Population: NUMBER OF PARTICIPANTS WAS DETERMINED BASED ON PER PROTOCOL NUMBER OF PATIENT ABLE TO BE CONTACTED VIA TELEPHONE
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telemedicine | 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 |
| 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. | 1 participants |
Secondary
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
Population: NUMBER OF PARTICIPANTS WAS DETERMINED BASED ON PER PROTOCOL NUMBER OF PATIENT ABLE TO BE CONTACTED VIA TELEPHONE
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telemedicine | Recurrent Stroke | 1 participants |
| Telephone | Recurrent Stroke | 2 participants |
Secondary
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
Population: NUMBER OF PARTICIPANTS WAS DETERMINED BASED ON PER PROTOCOL NUMBER OF PATIENT ABLE TO BE CONTACTED VIA TELEPHONE
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telemedicine | Recurrent Stroke | 0 participants |
| Telephone | Recurrent Stroke | 1 participants |