Powered Seating Function Usage Among Veterans - Compliance and Coaching

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00839098
First received: February 6, 2009
Last updated: January 5, 2016
Last verified: January 2016
Results First Received: March 9, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Use of Power Wheelchairs and Power Seat Functions
Interventions: Other: Instruction Group: Power seat function usage instruction- verbal and written instruction
Other: Instruction and Virtual Coach Group: Power seat function usage instruction- verbal, written, and virtual coach

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Control Group Control Group
Instruction Group

Instruction Group

Instruction Group: Power seat function usage instruction- verbal and written instruction: Subjects assigned to the Intervention Group will be assigned to an Intervention Group Clinician. The Intervention Group Clinicians will provide the same training as the Control Group Clinicians, with the addition of discussing the veteran's activity and seating function usage data, reviewing and providing a study pamphlet and compact disk as a reference guide on use of power seat functions.

Instruction and Virtual Coach Group

Instruction and Virtual Coach Group

Instruction and Virtual Coach Group: Power seat function usage instruction- verbal, written, and virtual coach: Subjects assigned to the Instruction & Virtual Coach Group will be assigned to an Intervention Group Clinician and will receive the same training and instructional materials as the Instruction Group. Subjects will also be instructed in use of the virtual coach system, which will be active during the in-home usage periods to provide personalized feedback. As the Virtual Coach is a dynamic intelligent system, it will adjust its coaching to the needs of the individual. For example, if the person is compliant, the Virtual Coach will give positive feedback and then gradually transition to operating quietly in the background. If a person is not fully compliant, it will alter feedback modes (e.g., verbal cues, auditory tones, visual cues) and timing to attempt to increase compliance.


Participant Flow:   Overall Study
    Control Group     Instruction Group     Instruction and Virtual Coach Group  
STARTED     3     12     13  
COMPLETED     1     11     6  
NOT COMPLETED     2     1     7  
Withdrawal by Subject                 2                 1                 7  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

The average age of the participants was 53.2 years old (+/- 14.0 years old). Twelve out of 28 were female (42.9%). Two of the participants were veterans, and one of them was recruited from VA Wheelchair Seating clinic.

Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.


Reporting Groups
  Description
Control Group Control Group
Instruction Group

Instruction Group

Instruction Group: Power seat function usage instruction- verbal and written instruction: Subjects assigned to the Intervention Group will be assigned to an Intervention Group Clinician. The Intervention Group Clinicians will provide the same training as the Control Group Clinicians, with the addition of discussing the veteran's activity and seating function usage data, reviewing and providing a study pamphlet and compact disk as a reference guide on use of power seat functions.

Instruction and Virtual Coach Group

Instruction and Virtual Coach Group

Instruction and Virtual Coach Group: Power seat function usage instruction- verbal, written, and virtual coach: Subjects assigned to the Instruction & Virtual Coach Group will be assigned to an Intervention Group Clinician and will receive the same training and instructional materials as the Instruction Group. Subjects will also be instructed in use of the virtual coach system, which will be active during the in-home usage periods to provide personalized feedback. As the Virtual Coach is a dynamic intelligent system, it will adjust its coaching to the needs of the individual. For example, if the person is compliant, the Virtual Coach will give positive feedback and then gradually transition to operating quietly in the background. If a person is not fully compliant, it will alter feedback modes (e.g., verbal cues, auditory tones, visual cues) and timing to attempt to increase compliance.

Total Total of all reporting groups

Baseline Measures
    Control Group     Instruction Group     Instruction and Virtual Coach Group     Total  
Number of Participants  
[units: participants]
  3     12     13     28  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     3     11     9     23  
>=65 years     0     1     4     5  
Age  
[units: Years of age]
Mean (Standard Deviation)
  47.0  (19.9)     53.4  (9.1)     54.5  (17.0)     53.2  (14.0)  
Gender  
[units: participants]
       
Female     2     5     5     12  
Male     1     7     8     16  
Region of Enrollment  
[units: participants]
       
United States     3     12     13     28  



  Outcome Measures
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1.  Primary:   Compliance Rate   [ Time Frame: Every 2 weeks for 8 weeks following acquisition of wheelchair ]

2.  Primary:   Frequency of Power Seat Function Usage   [ Time Frame: Every 2 weeks for 8 weeks following acquisition of wheelchair ]

3.  Primary:   Power Wheelchair Usage   [ Time Frame: Every 2 weeks for 8 weeks following acquisition of wheelchair ]

4.  Primary:   Wheelchair Occupancy   [ Time Frame: Every 2 weeks for 8 weeks following acquisition of wheelchair ]

5.  Secondary:   Questionnaire Responses: Tool for Assessing Wheelchair Discomfort (TAWC)   [ Time Frame: Every 2 weeks for 8 weeks following acquisition of wheelchair ]

6.  Secondary:   Questionnaire Responses: Psychological Impacts of Assistive Devices Scale   [ Time Frame: At the end of every two weeks ]

7.  Secondary:   Questionnaire Responses: Independence in Community   [ Time Frame: At the end of 2nd (end of baseline) week and 8th week (end of intervention period) following acquisition of wheelchair ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
It was difficult to recruit power wheelchair users to participate in the study. Participants withdrew from the study because the study wheelchair could not meet their needs, or they could not use the Virtual Seating Coach independently.


  More Information
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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: Clinical Coordinator
Organization: Human Engineering Reserach Laboratories
phone: 412-822-3700
e-mail: annmarie.kelleher@va.gov



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00839098     History of Changes
Other Study ID Numbers: B6591-R
Study First Received: February 6, 2009
Results First Received: March 9, 2015
Last Updated: January 5, 2016
Health Authority: United States: Federal Government