Home-based Telehealth Stroke Care: A Randomized Trial for Veterans
Study Details
Study Description
Brief Summary
The purpose of the proposed study is to examine a Tele-rehabilitation (TR) intervention that uses tele-health technology to improve outcomes of stroke patients after discharge to home. The primary aim is to determine the effect of TR on physical function, and secondarily to determine the effect on disability, falls-related self-efficacy, and patient satisfaction.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Stroke patients clearly benefit from intensive, coordinated, inpatient care. At the same time, there is considerable interest in ways to reduce hospital lengths of stay. Early discharge rehabilitation programs require coordinated, well-organized home-based rehabilitation, and lack of sufficient information about the home setting impedes successful rehabilitation. Unfortunately, resources for in-home rehabilitation are limited. The goal of TR is to improve functional mobility using a multifaceted rehabilitation intervention via two types of telehealth technology. Tele-video is used to carry out an in-home assessment of functional mobility, to make treatment recommendations, and to provide periodic goal-oriented reassessment, modifying the treatment plan as the patient improves. Tele-video uses a video camera with a home health aide in the patient's home to provide visual and audio to a therapist located at the base hospital. It is used to carry out an in-home assessment of functional mobility, to make treatment recommendations, and to provide periodic goal-oriented reassessment, modifying the treatment plan as the patient improves. An interactive, in-home messaging device is used to facilitate adherence with treatment recommendations and to screen for interval problems (depression, falls, and difficulty with self-care).
This is a Phase II, 2-arm, 3-site Randomized Controlled Trial (RCT). A total of 120 veterans with recent onset of ischemic or hemorrhagic stroke who are discharged to the community will be randomly assigned to one of two groups: (a) TR; and (b) Usual Care. Dependent variables (physical function, disability, falls-related self-efficacy, and patient satisfaction) will be measured at baseline, 3-, and 6-months via telephone interviews by the study coordinator located at the CIEBP who will be blinded to the study group assignment of the patient.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tele-visit Group TR intervention targets safe functional mobility within a home environment and consists of: 1) exercise targeting underlying stroke-related impairment and 2) adaptive strategies targeting external factors to help compensate for disability. TR uses a combination of tele-video visits, an in-home messaging device, and telephone contact over a 3-month study period. A video camera is used in the home to provide visual and audio to a therapist located at the base hospital. An interactive, in-home messaging device is used to facilitate adherence with treatment recommendations and to screen for depression, falls, and difficulty with self-care. This allows evaluations of problem areas during tele-visits, rapid response to new functional problems. |
Behavioral: TR intervention
The 3 tele-visits will occur within 5 weeks post randomization. Telephone call visits will occur during weeks 2, 4, 6, 8 and 12. One additional tele-visit may be scheduled as needed. The first visit is devoted to mobility assessment, goal-setting. The second visit is to review the current exercise component. Visit 3 focuses on functional mobility using adaptive strategy component.
Other Names:
Behavioral: In-home messaging device.
The purpose of this aspect of the intervention is to screen for unforeseen problems and to reinforce adherence to the recommended treatment. It will be used to interface with patients daily, but briefly. The in-home messaging device, which resembles a caller ID box is attached to the home telephone line and electrical outlet. Installation of the equipment involves connecting it to the phone line and plugging it into an electrical outlet. The teletherapist receives the clinical data from the in-home messaging device via the internet on a daily basis. It is used to screen for depression, lower extremity strength, self-care tasks and mobility, falls and exercise adherence.
|
| Active Comparator: Usual Care Group Patients randomized to the Usual Care group receive routine VA care, as directed by their physicians. Therapy services are tracked via a weekly diary for the entire 6 month study period. In this weekly diary, patients in both the usual care and intervention group will record receipt of therapy. Usual Care group will be asked whether they exercised, and if so how frequently. They will be administered telephone interviews at baseline, 3-and 6-months. The interview outcome measures are FONEFIM, Late-Life Function and Disability Instrument, Falls Self Efficacy Scale and Stroke Specific Patient Satisfaction with Care. In addition, sociodemographics, stroke severity, length of time since stroke onset, and depression at baseline will be measured. |
Behavioral: Usual care
Routine VA care.
|
Outcome Measures
Primary Outcome Measures
- Physical Function as Measured by Telephone Version of FIM [6-month]
The FONEFIM was developed as a telephonic alternative and yields good concordance to the in-person, performance based FIM.12 The motor subscale of the FONEFIM (Motor FONEFIM) consists of 13 items encompassing four categories: 1) self-care; 2) sphincter control; 3) transfers; and 4) locomotion. Each item is scored on an ordinal scale from 1= total dependence to 7 = total independence. Possible scores range from 13 to 91, with higher scores indicating greater independence. The scoring considers the use of adaptive equipment and/or the extent of personal assistance or supervision required to complete the task.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Have acute ischemic or hemorrhagic stroke within the preceding twenty-four months, defined as "a rapid onset event of vascular origin reflecting a focal disturbance of cerebral function, excluding isolated impairments of higher function and persisting longer than 24 hours";
-
age between 45-90;
-
discharge to the community;
-
cognitively intact (score of 6/10 or greater on the Short Portable Mental Status Questionnaire);
-
discharge motor Functional Independence Measure (FIM) score of 17-88 (i.e., maximal assistance on no more than 4 motor activities of daily living (ADLs) as the most severe stroke included and modified independence at least 2 motor ADLs as the least severe); able to follow 3-step command; signed VHA Medical Media release form; concurrence by the patient's physician;
-
and informed consent
Exclusion Criteria:
Unable to provide informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Atlanta VA Medical and Rehab Center, Decatur | Decatur | Georgia | United States | 30033 |
| 2 | Richard Roudebush VA Medical Center, Indianapolis | Indianapolis | Indiana | United States | 46202-2884 |
| 3 | VA Medical Center, Durham | Durham | North Carolina | United States | 27705 |
Sponsors and Collaborators
- US Department of Veterans Affairs
Investigators
- Principal Investigator: Neale R. Chumbler, PhD MA BS, Richard Roudebush VA Medical Center, Indianapolis
- Principal Investigator: Patricia A Quigley, PhD MPH, James A. Haley Veterans Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- B4492-R
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Arm 1 | Arm 2 |
|---|---|---|
| Arm/Group Description | TR intervention consists of two parts 1) exercise targeting underlying stroke-related impairment and 2) adaptive strategies to help compensate for disability. An in-home messaging device is used to facilitate adherence with treatment recommendations and to screen for problems. This will allow targeted evaluations of problem areas during tele-visits, rapid response to new functional problems. The 3 tele-visits will occur within 5 weeks post randomization. Telephone call visits will occur during even weeks.The first visit is devoted to mobility assessment, goal-setting. The second visit is to review the current exercise component. In-home messaging device. The teletherapist receives the clinical data from the in-home messaging device on a daily basis to screen for depression, lower extremity strength, self-care tasks and mobility, falls and exercise adherence. | Patients randomized to the Usual Care group receive routine VA care, as directed by their physicians. Receipt of therapy services will be tracked via a weekly diary for the entire 6 months of the intervention period. In this weekly diary, patients in both the usual care and intervention group will record receipt of therapy. The patients will be asked to include the time in minutes that they spent in receipt of therapy services. Both groups will also be asked whether or not they exercised, and if so how frequently. TR and Usual Care participants will be administered telephone interviews at baseline, 3-and 6-months. The interview outcome measures are FONEFIM, Late-Life Function and Disability Instrument, Falls Self Efficacy Scale and Stroke Specific Patient Satisfaction with Care. In addition, sociodemographics, stroke severity, length of time since stroke onset, and depression at baseline will be measured. Usual care: Routine VA care. |
| Period Title: Overall Study | ||
| STARTED | 25 | 23 |
| COMPLETED | 25 | 23 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Arm/Group Description | TR intervention consists of two parts 1) exercise targeting underlying stroke-related impairment and 2) adaptive strategies to help compensate for disability. An in-home messaging device is used to facilitate adherence with treatment recommendations and to screen for problems. This will allow targeted evaluations of problem areas during tele-visits, rapid response to new functional problems. The 3 tele-visits will occur within 5 weeks post randomization. Telephone call visits will occur during even weeks.The first visit is devoted to mobility assessment, goal-setting. The second visit is to review the current exercise component. In-home messaging device. The teletherapist receives the clinical data from the in-home messaging device on a daily basis to screen for depression, lower extremity strength, self-care tasks and mobility, falls and exercise adherence. | Patients randomized to the Usual Care group receive routine VA care, as directed by their physicians. Receipt of therapy services will be tracked via a weekly diary for the entire 6 months of the intervention period. In this weekly diary, patients in both the usual care and intervention group will record receipt of therapy. The patients will be asked to include the time in minutes that they spent in receipt of therapy services. Both groups will also be asked whether or not they exercised, and if so how frequently. TR and Usual Care participants will be administered telephone interviews at baseline, 3-and 6-months. The interview outcome measures are FONEFIM, Late-Life Function and Disability Instrument, Falls Self Efficacy Scale and Stroke Specific Patient Satisfaction with Care. In addition, sociodemographics, stroke severity, length of time since stroke onset, and depression at baseline will be measured. Usual care: Routine VA care. | Total of all reporting groups |
| Overall Participants | 25 | 23 | 48 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
10
40%
|
9
39.1%
|
19
39.6%
|
| >=65 years |
15
60%
|
14
60.9%
|
29
60.4%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
0
0%
|
0
0%
|
0
0%
|
| Male |
25
100%
|
23
100%
|
48
100%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
25
100%
|
23
100%
|
48
100%
|
Outcome Measures
| Title | Physical Function as Measured by Telephone Version of FIM |
|---|---|
| Description | The FONEFIM was developed as a telephonic alternative and yields good concordance to the in-person, performance based FIM.12 The motor subscale of the FONEFIM (Motor FONEFIM) consists of 13 items encompassing four categories: 1) self-care; 2) sphincter control; 3) transfers; and 4) locomotion. Each item is scored on an ordinal scale from 1= total dependence to 7 = total independence. Possible scores range from 13 to 91, with higher scores indicating greater independence. The scoring considers the use of adaptive equipment and/or the extent of personal assistance or supervision required to complete the task. |
| Time Frame | 6-month |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Arm 1 | Arm 2 |
|---|---|---|
| Arm/Group Description | TR intervention consists of two parts 1) exercise targeting underlying stroke-related impairment and 2) adaptive strategies to help compensate for disability. An in-home messaging device is used to facilitate adherence with treatment recommendations and to screen for problems. This will allow targeted evaluations of problem areas during tele-visits, rapid response to new functional problems. The 3 tele-visits will occur within 5 weeks post randomization. Telephone call visits will occur during even weeks.The first visit is devoted to mobility assessment, goal-setting. The second visit is to review the current exercise component. In-home messaging device. The teletherapist receives the clinical data from the in-home messaging device on a daily basis to screen for depression, lower extremity strength, self-care tasks and mobility, falls and exercise adherence. | Patients randomized to the Usual Care group receive routine VA care, as directed by their physicians. Receipt of therapy services will be tracked via a weekly diary for the entire 6 months of the intervention period. In this weekly diary, patients in both the usual care and intervention group will record receipt of therapy. The patients will be asked to include the time in minutes that they spent in receipt of therapy services. Both groups will also be asked whether or not they exercised, and if so how frequently. TR and Usual Care participants will be administered telephone interviews at baseline, 3-and 6-months. The interview outcome measures are FONEFIM, Late-Life Function and Disability Instrument, Falls Self Efficacy Scale and Stroke Specific Patient Satisfaction with Care. In addition, sociodemographics, stroke severity, length of time since stroke onset, and depression at baseline will be measured. Usual care: Routine VA care. |
| Measure Participants | 25 | 23 |
| Mean (Standard Deviation) [units on a scale] |
83.7
(9.9)
|
80.9
(12.0)
|
Adverse Events
| Time Frame | Adverse events were collected from the enrollment of the first subject until all subjects had completed the study. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Arm 1 | Arm 2 | ||
| Arm/Group Description | TR intervention consists of two parts 1) exercise targeting underlying stroke-related impairment and 2) adaptive strategies to help compensate for disability. An in-home messaging device is used to facilitate adherence with treatment recommendations and to screen for problems. This will allow targeted evaluations of problem areas during tele-visits, rapid response to new functional problems. The 3 tele-visits will occur within 5 weeks post randomization. Telephone call visits will occur during even weeks.The first visit is devoted to mobility assessment, goal-setting. The second visit is to review the current exercise component. In-home messaging device. The teletherapist receives the clinical data from the in-home messaging device on a daily basis to screen for depression, lower extremity strength, self-care tasks and mobility, falls and exercise adherence. | Patients randomized to the Usual Care group receive routine VA care, as directed by their physicians. Receipt of therapy services will be tracked via a weekly diary for the entire 6 months of the intervention period. In this weekly diary, patients in both the usual care and intervention group will record receipt of therapy. The patients will be asked to include the time in minutes that they spent in receipt of therapy services. Both groups will also be asked whether or not they exercised, and if so how frequently. TR and Usual Care participants will be administered telephone interviews at baseline, 3-and 6-months. The interview outcome measures are FONEFIM, Late-Life Function and Disability Instrument, Falls Self Efficacy Scale and Stroke Specific Patient Satisfaction with Care. In addition, sociodemographics, stroke severity, length of time since stroke onset, and depression at baseline will be measured. Usual care: Routine VA care. | ||
All Cause Mortality |
||||
| Arm 1 | Arm 2 | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Arm 1 | Arm 2 | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/25 (0%) | 0/23 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Arm 1 | Arm 2 | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/25 (0%) | 0/23 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Neale Chumbler, PhD |
|---|---|
| Organization | University of Georgia |
| Phone | 706-369-5975 |
| chumbler@uga.edu |
- B4492-R