Powered Seating Function Usage Among Veterans - Compliance and Coaching

NCT ID: NCT00839098

Last Updated: 2016-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2014-11-30

Brief Summary

The purpose of this randomized control study is to evaluate the use of electric powered wheelchairs and powered seating function patterns of Veterans to determine how usage patterns relate to activity, participation, and seating discomfort. In addition, it will be determined if a training program or a training program with a virtual coach will improve compliance of clinical practice guidelines for pressure relief, upper limb preservation, and discomfort management. The virtual coach is a portable, programmable intelligent reminder designed to enhance a person's use of their power wheelchair and power seat functions.

Detailed Description

This is a randomized control trial evaluating power seat function usage among 3 groups: 1) standard of care- verbal instruction 2) verbal and written instruction and 3) same as #2 with addition of virtual coach. This study will be conducted in two phases. Phase I data will be collected for 8 weeks, during the time period that the subject is awaiting for delivery of their personal electric powered wheelchair (EPW) with powered seat functions. Phase II data will be collected for a total of 4 weeks, after the subject receives their personal wheelchair. During Phase I, Visit I, subjects will be fitted for a study EPW with powered seat functions. All subjects will be provided with the "standard of care" training on driving of the wheelchair and usage of the power seating functions. Subjects will be instructed to go about their daily activities as they normally would, while the instrumented wheelchair will track their usage of the wheelchair and seating habits. Phase I, Visit II-IV, subjects will be randomized into one of three study groups: Control Group; Instruction Group; and Instruction & Virtual Coach Group. Subjects assigned to the Control Group will receive 'standard of care.' Subjects assigned to the Intervention Group will receive the "standard of care" and additional written instructional materials and feedback regarding activity and wheelchair usage. Subjects assigned to the Instruction & Virtual Coach Group will receive the same training and instructional materials as the Intervention Group. This group 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. Phase II will involve mounting a wheelchair and seat function usage datalogger to the subject's personal wheelchair over a period of 4 weeks.

Conditions

Use of Power Wheelchairs and Power Seat Functions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Control Group

Control Group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Instruction Group

Instruction Group

Group Type: EXPERIMENTAL

Instruction Group: Power seat function usage instruction- verbal and written instruction

Intervention Type: OTHER

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

Group Type: EXPERIMENTAL

Instruction and Virtual Coach Group: Power seat function usage instruction- verbal, written, and virtual coach

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Subjects must be 18 years of age or older.
• A power wheelchair with power seat functions must be recommended as medically necessary by a qualified clinician with ATP credential or board certified in physical medicine and rehabilitation from the VAPHS Wheelchair and Seating Clinic or the Center for Assistive Technology.
• Subjects must be able to be properly fitted with one of the study EPWs; 18" or 20" seat widths will be available. Cushions and backrests will be made available to meet subject's clinical needs.
• Subject's home must be accessible to accommodate use of a power w/c.
• Subject must be determined to be fully capable of examining his/her sitting surface daily for redness or pressure ulcers or if not that another individual can be designated as able and willing to-do this.

Exclusion Criteria

• Subjects who have active pelvic, gluteal or thigh wounds or who have had a pressure ulcer in these regions within the past 30 days. (They may be worsened by prolonged sitting).
• Subjects who report more than 5 days of hospitalization in the previous month. (They may not spend enough time using an EPW with powered seating functions).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rory A. Cooper, PhD

Role: PRINCIPAL_INVESTIGATOR

Director, Center of Excellence for Wheelchairs and Related Technology

Locations

VA Pittsburgh Health Care System

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

B6591-R

Identifier Type: -

Identifier Source: org_study_id