Home-based Telehealth Stroke Care: A Randomized Trial for Veterans

Completed

Phase 2 Results

Trial Description

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.

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.

Conditions

Interventions

  • Best Medical Treatment Procedure
    Intervention Desc: up-to-date medical treatment
  • Tele-rehabilitation Other
    Intervention Desc: intervention that uses tele-health technology to provide live visual and audio from any location in the home between the patient, home health aid, and 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 problems (depression, falls, and difficulty with self-care).
  • Usual care Other
    Intervention Desc: Routine VA care.
    ARM 1: Kind: Experimental
    Label: 2
    Description: 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.
    ARM 2: Kind: Experimental
    Label: Arm 2
    Description: 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.
    ARM 3: Kind: Experimental
    Label: Usual Care Group
    Description: 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.
  • Tele-visit intervention Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: 1
    Description: TR intervention consists of two parts that target safe functional mobility of the individual within a home environment: 1) exercise targeting underlying stroke-related impairment and 2) adaptive strategies targeting external factors to help compensate for disability. TR will use a combination of 3 tele-video visits, an in-home messaging device, and telephone contact over a 3-month study period to provide a progressive TR intervention with goal of safe functional mobility of the patient. A home health aide uses the video camera in the patient's 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 problems (depression, falls, and difficulty with self-care). This will allow targeted evaluations of problem areas during tele-visits, rapid response to new functional problems.
    ARM 2: Kind: Experimental
    Label: Arm 1
    Description: TR intervention consists of two parts that target safe functional mobility of the individual within a home environment: 1) exercise targeting underlying stroke-related impairment and 2) adaptive strategies targeting external factors to help compensate for disability. TR will use a combination of 3 tele-video visits, an in-home messaging device, and telephone contact over a 3-month study period to provide a progressive TR intervention with goal of safe functional mobility of the patient. A home health aide uses the video camera in the patient's 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 problems (depression, falls, and difficulty with self-care). This will allow targeted evaluations of problem areas during tele-visits, rapid response to new functional problems.
  • In-home messaging device. Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: 1
    Description: TR intervention consists of two parts that target safe functional mobility of the individual within a home environment: 1) exercise targeting underlying stroke-related impairment and 2) adaptive strategies targeting external factors to help compensate for disability. TR will use a combination of 3 tele-video visits, an in-home messaging device, and telephone contact over a 3-month study period to provide a progressive TR intervention with goal of safe functional mobility of the patient. A home health aide uses the video camera in the patient's 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 problems (depression, falls, and difficulty with self-care). This will allow targeted evaluations of problem areas during tele-visits, rapid response to new functional problems.
    ARM 2: Kind: Experimental
    Label: Arm 1
    Description: TR intervention consists of two parts that target safe functional mobility of the individual within a home environment: 1) exercise targeting underlying stroke-related impairment and 2) adaptive strategies targeting external factors to help compensate for disability. TR will use a combination of 3 tele-video visits, an in-home messaging device, and telephone contact over a 3-month study period to provide a progressive TR intervention with goal of safe functional mobility of the patient. A home health aide uses the video camera in the patient's 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 problems (depression, falls, and difficulty with self-care). This will allow targeted evaluations of problem areas during tele-visits, rapid response to new functional problems.
    ARM 3: Kind: Experimental
    Label: Tele-visit Group
    Description: 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.
  • TR intervention Behavioral
    Other Names: Tele-visit intervention
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Tele-visit Group
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Factorial Assignment

Patient Involvement

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. Randomization will be centrally-sealed allocation upon discharge to the community. Dependent variables (physical function, disability, falls-related self-efficacy, and patient satisfaction) will be measured at baseline, 3-, 6-, and 9-months via telephone interviews by the study coordinator located at the RORC who will be blinded to the study group assignment of the patient.

Outcomes

Type Measure Time Frame Safety Issue
Primary Physical function as measured by telephone version of FIM.
Primary physical function as measured by telephone version of FIM 6-month No

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