Cerebrovascular AccidentPhase 2NCT00384748
Home-based Telehealth Stroke Care: A Randomized Trial for Veterans
A Phase 2 study testing TR intervention and In-home messaging device. in people with Cerebrovascular Accident, run by US Department of Veterans Affairs at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- TR intervention and In-home messaging device.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2008to Jun 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to provide informed consent
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Atlanta VA Medical and Rehab Center, Decatur
Decatur, Georgia, 30033
VA Medical Center, Durham
Durham, North Carolina, 27705
Richard Roudebush VA Medical Center, Indianapolis
Indianapolis, Indiana, 46202-2884
About this study
Official title: Home-Based Tele-Health Stroke Care: A Randomized Trial for Veterans
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.
Read the 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
- Cerebrovascular Accident
- Being tested
- TR intervention, In-home messaging device., Usual care
- Keywords
- Cerebrovascular Accident, Rehabilitation, Telemedicine
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TR interventionBehavioural
Also called Tele-visit 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.
In-home messaging device.Behavioural
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.
Usual careBehavioural
Routine VA care.
| Study group | Role | What they receive |
|---|---|---|
| Tele-visit Group | Experimental | 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. Receives: Behavioral: TR intervention; Behavioral: In-home messaging device. |
| Usual Care Group | Active comparator | 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. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Function as Measured by Telephone Version of FIM
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.
Measured: 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2006 (estimated)
- Study startNov 2008
- Primary completionDec 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Neale R. Chumbler, PhD MA BS, Principal investigator, Richard Roudebush VA Medical Center, IndianapolisPatricia A Quigley, PhD MPH, Principal investigator, James A. Haley Veterans Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00384748
- Sponsor's protocol ID
- B4492-R
- Status last verified
- Nov 2014
- First submitted
- 3 Oct 2006
- Last updated
- 24 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Lutz BJ, Chumbler NR, Lyles T, Hoffman N, Kobb R. Testing a home-telehealth programme for US veterans recovering from stroke and their family caregivers. Disabil Rehabil. 2009;31(5):402-9. doi: 10.1080/09638280802069558.
PubMed 18720112Chumbler NR, Rose DK, Griffiths P, Quigley P, McGee-Hernandez N, Carlson KA, Vandenberg P, Morey MC, Sanford J, Hoenig H. Study protocol: home-based telehealth stroke care: a randomized trial for veterans. Trials. 2010 Jun 30;11:74. doi: 10.1186/1745-6215-11-74.
PubMed 20591171Chumbler NR, Morey M, Quigley P, Rose D, Sanford J, Hoenig H. Tele-rehabilitation for Stroke Care: A Randomized Trial for Veterans. [Abstract]. Telemedicine journal and e-health : the official journal of the American Telemedicine Association. 2010 May 1; 16 Suppl 1:s30.
Chumbler NR, Morey MC, Griffiths P, Quigley P, Haley JA, Rose DK, Sanford J, Hoenig H. The Effects of a Stroke Telerehabilitation In-Home Intervention on Function and Disability: Preliminary Results of a Randomized Clinical Trial. [Abstract]. Stroke; A Journal of Cerebral Circulation. 2011 Mar 1; 42(3):e76.
Chumbler NR, Quigley P, Li X, Morey M, Rose D, Sanford J, Griffiths P, Hoenig H. Effects of telerehabilitation on physical function and disability for stroke patients: a randomized, controlled trial. Stroke. 2012 Aug;43(8):2168-74. doi: 10.1161/STROKEAHA.111.646943. Epub 2012 May 24.
PubMed 22627983
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Tele-Health Stroke Care: A Randomized Trial for Veterans
- ClinicalTrials.gov ID
- NCT00384748
- Acronym / sponsor ID
- B4492-R
- Conditions
- Cerebrovascular Accident
- Keywords
- Cerebrovascular Accident, Rehabilitation, Telemedicine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Nov 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 6 Oct 2006 (estimated)
- Results
- Posted 10 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele-visit Group | Experimental | Behavioral: TR intervention, Behavioral: In-home messaging device.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. |
| Usual Care Group | Active comparator | Behavioral: Usual carePatients 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. |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (1 listed)
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TR interventionAlso: Tele-visit interventionThe 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. | Behavioural | Tele-visit Group |
| 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. | Behavioural | Tele-visit Group |
| Usual careRoutine VA care. | Behavioural | Usual Care Group |
Primary outcome
Physical Function as Measured by Telephone Version of FIM
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18720112Lutz BJ, Chumbler NR, Lyles T, Hoffman N, Kobb R. Testing a home-telehealth programme for US veterans recovering from stroke and their family caregivers. Disabil Rehabil. 2009;31(5):402-9. doi: 10.1080/09638280802069558.
- Results publication: PubMed 20591171Chumbler NR, Rose DK, Griffiths P, Quigley P, McGee-Hernandez N, Carlson KA, Vandenberg P, Morey MC, Sanford J, Hoenig H. Study protocol: home-based telehealth stroke care: a randomized trial for veterans. Trials. 2010 Jun 30;11:74. doi: 10.1186/1745-6215-11-74.
- Results publicationChumbler NR, Morey M, Quigley P, Rose D, Sanford J, Hoenig H. Tele-rehabilitation for Stroke Care: A Randomized Trial for Veterans. [Abstract]. Telemedicine journal and e-health : the official journal of the American Telemedicine Association. 2010 May 1; 16 Suppl 1:s30.
- Results publicationChumbler NR, Morey MC, Griffiths P, Quigley P, Haley JA, Rose DK, Sanford J, Hoenig H. The Effects of a Stroke Telerehabilitation In-Home Intervention on Function and Disability: Preliminary Results of a Randomized Clinical Trial. [Abstract]. Stroke; A Journal of Cerebral Circulation. 2011 Mar 1; 42(3):e76.
- Results publication: PubMed 22627983Chumbler NR, Quigley P, Li X, Morey M, Rose D, Sanford J, Griffiths P, Hoenig H. Effects of telerehabilitation on physical function and disability for stroke patients: a randomized, controlled trial. Stroke. 2012 Aug;43(8):2168-74. doi: 10.1161/STROKEAHA.111.646943. Epub 2012 May 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neale R. Chumbler, PhD MA BS principal investigator
Richard Roudebush VA Medical Center, Indianapolis
Patricia A Quigley, PhD MPH principal investigator
James A. Haley Veterans Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TR intervention and In-home messaging device. in people with Cerebrovascular Accident, run by US Department of Veterans Affairs at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Function as Measured by Telephone Version of FIM (time frame: 6-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00384748, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2014.