ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00384748
Recruitment Status : Completed
First Posted : October 6, 2006
Results First Posted : November 10, 2014
Last Update Posted : November 24, 2014
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cerebrovascular Accident
Interventions Behavioral: TR intervention
Behavioral: In-home messaging device.
Behavioral: Usual care
Enrollment 48
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1 Arm 2
Hide 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
Arm/Group Title Arm 1 Arm 2 Total
Hide 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 Number of Baseline Participants 25 23 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 23 participants 48 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
  40.0%
9
  39.1%
19
  39.6%
>=65 years
15
  60.0%
14
  60.9%
29
  60.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 23 participants 48 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
25
 100.0%
23
 100.0%
48
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 23 participants 48 participants
25 23 48
1.Primary Outcome
Title Physical Function as Measured by Telephone Version of FIM
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Arm 2
Hide 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.

Overall Number of Participants Analyzed 25 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
83.7  (9.9) 80.9  (12.0)
Time Frame Adverse events were collected from the enrollment of the first subject until all subjects had completed the study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 Arm 2
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/23 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1 Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/23 (0.00%) 
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
Publications of Results:
Chumbler 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.
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00384748     History of Changes
Other Study ID Numbers: B4492-R
First Submitted: October 3, 2006
First Posted: October 6, 2006
Results First Submitted: October 22, 2014
Results First Posted: November 10, 2014
Last Update Posted: November 24, 2014