Trial Outcomes & Findings for Powered Seating Function Usage Among Veterans - Compliance and Coaching (NCT NCT00839098)
NCT ID: NCT00839098
Last Updated: 2016-02-04
Results Overview
Compliance rate is a measure of compliance with the recommendation of using powered seating functions (moderate or maximum range of tilt, at least once every hour, for 2 minutes). The participant had to follow the recommended position, duration, and frequency to be considered as compliant and performed successful repositioning exercise. The compliance rate of a participant was the number of successful repositioning exercise divided by the sum of the number of successful repositioning exercise and missed repositioning exercise. The result of the difference between the baseline and week 7-8 (last 2 weeks) was shown here.
COMPLETED
NA
28 participants
Every 2 weeks for 8 weeks following acquisition of wheelchair
2016-02-04
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
12
|
13
|
|
Overall Study
COMPLETED
|
1
|
11
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
7
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
7
|
Baseline Characteristics
Powered Seating Function Usage Among Veterans - Compliance and Coaching
Baseline characteristics by cohort
| Measure |
Control Group
n=3 Participants
Control Group
|
Instruction Group
n=12 Participants
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
n=13 Participants
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
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=113 Participants
|
11 Participants
n=163 Participants
|
9 Participants
n=160 Participants
|
23 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
4 Participants
n=160 Participants
|
5 Participants
n=483 Participants
|
|
Age, Continuous
|
47.0 Years of age
STANDARD_DEVIATION 19.9 • n=113 Participants
|
53.4 Years of age
STANDARD_DEVIATION 9.1 • n=163 Participants
|
54.5 Years of age
STANDARD_DEVIATION 17.0 • n=160 Participants
|
53.2 Years of age
STANDARD_DEVIATION 14.0 • n=483 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=113 Participants
|
5 Participants
n=163 Participants
|
5 Participants
n=160 Participants
|
12 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=113 Participants
|
7 Participants
n=163 Participants
|
8 Participants
n=160 Participants
|
16 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=113 Participants
|
12 participants
n=163 Participants
|
13 participants
n=160 Participants
|
28 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Every 2 weeks for 8 weeks following acquisition of wheelchairPopulation: Only the data of the participants who completed the study protocol and use the wheelchair were included in the data analysis.
Compliance rate is a measure of compliance with the recommendation of using powered seating functions (moderate or maximum range of tilt, at least once every hour, for 2 minutes). The participant had to follow the recommended position, duration, and frequency to be considered as compliant and performed successful repositioning exercise. The compliance rate of a participant was the number of successful repositioning exercise divided by the sum of the number of successful repositioning exercise and missed repositioning exercise. The result of the difference between the baseline and week 7-8 (last 2 weeks) was shown here.
Outcome measures
| Measure |
Arm 1: Control Group
Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
|
Arm 2: Instruction Group
n=10 Participants
Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
|
Arm 3: Instruction + VSC Group
n=6 Participants
Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
|
|---|---|---|---|
|
Compliance Rate
|
—
|
8.9 Percentage of participants' compliance
Standard Deviation 15.9
|
39.7 Percentage of participants' compliance
Standard Deviation 23.5
|
PRIMARY outcome
Timeframe: Every 2 weeks for 8 weeks following acquisition of wheelchairPopulation: Only the data of the participants who completed the study protocol and use the wheelchair were included in the data analysis.
Frequency of power seat function usage was measured by the number of times of changing tilt and recline angles averaged by the duration that the participant occupied the wheelchair per day. The results of the difference between the baseline and week 7-8 (last 2 weeks) were shown here.
Outcome measures
| Measure |
Arm 1: Control Group
Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
|
Arm 2: Instruction Group
n=10 Participants
Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
|
Arm 3: Instruction + VSC Group
n=6 Participants
Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
|
|---|---|---|---|
|
Frequency of Power Seat Function Usage
Freq of mod & max tilt (times/hr): Difference
|
—
|
.51 times/hour
Standard Deviation 2.52
|
0.03 times/hour
Standard Deviation 2.51
|
|
Frequency of Power Seat Function Usage
Freq of mod & max recline (times/hr): Difference
|
—
|
-0.43 times/hour
Standard Deviation 1.36
|
0.09 times/hour
Standard Deviation 0.15
|
PRIMARY outcome
Timeframe: Every 2 weeks for 8 weeks following acquisition of wheelchairPopulation: Only the data of the participants who completed the study protocol and use the wheelchair were included in the data analysis.
Power wheelchair usage was measured by the sum of distances that the power wheelchair traveled (km) divided by the duration of the wheelchair being occupied a day (hr). The result of the difference between the baseline and week 7-8 (last 2 weeks) was shown here.
Outcome measures
| Measure |
Arm 1: Control Group
Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
|
Arm 2: Instruction Group
n=10 Participants
Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
|
Arm 3: Instruction + VSC Group
n=6 Participants
Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
|
|---|---|---|---|
|
Power Wheelchair Usage
|
—
|
0.17 km/hour
Standard Deviation 0.45
|
-0.04 km/hour
Standard Deviation 0.08
|
PRIMARY outcome
Timeframe: Every 2 weeks for 8 weeks following acquisition of wheelchairPopulation: Only the data of the participants who completed the study protocol and use the wheelchair were included in the data analysis.
Wheelchair occupancy was measured by the sum of duration that the seat of the wheelchair was occupied. The results of the difference between the baseline and week 7-8 (last 2 weeks) were shown here.
Outcome measures
| Measure |
Arm 1: Control Group
Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
|
Arm 2: Instruction Group
n=10 Participants
Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
|
Arm 3: Instruction + VSC Group
n=6 Participants
Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
|
|---|---|---|---|
|
Wheelchair Occupancy
|
—
|
-.07 hours
Standard Deviation 1.9
|
-0.4 hours
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Every 2 weeks for 8 weeks following acquisition of wheelchairGeneral Discomfort Assessment (GD) and Discomfort Intensity Rating (DI) are two sub-scales of TAWC. Higher scores indicate greater discomfort. GD consists of 8 discomfort statements and 5 comfort statements. The statements are rated on a seven point Likert scale, from strongly disagree to strongly agree of points from 1-7 (total score: 13-91). DI includes seven body areas (back, neck, buttocks, legs, arms, feet, and hands) and overall discomfort level, rated for a degree of discomfort intensity on a scale of 0 (no discomfort) to 10 (severe discomfort). Space is also included for the user to list additional body areas. DI scores may range from 0 to more than 80, depending on whether the participant reported additional areas of discomfort. Although GD and DI were measured daily, the data were average for each two-week period. The average GD and DI of the difference between the baseline and week 7-8 (last 2 weeks) were shown here.
Outcome measures
| Measure |
Arm 1: Control Group
Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
|
Arm 2: Instruction Group
n=10 Participants
Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
|
Arm 3: Instruction + VSC Group
n=6 Participants
Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
|
|---|---|---|---|
|
Questionnaire Responses: Tool for Assessing Wheelchair Discomfort (TAWC)
General Discomfort: Difference
|
—
|
4.6 units on a scale
Standard Deviation 7.5
|
-7.4 units on a scale
Standard Deviation 16.9
|
|
Questionnaire Responses: Tool for Assessing Wheelchair Discomfort (TAWC)
Discomfort Index: Difference
|
—
|
1.8 units on a scale
Standard Deviation 10.0
|
-12.1 units on a scale
Standard Deviation 13.6
|
SECONDARY outcome
Timeframe: At the end of every two weeksPopulation: Only the data of the participants who completed the study protocol and use the wheelchair were included in the data analysis.
This tool is to measure perceived psychological impact of using an assistive device. It consists of three subscales, Competence (12 items), Adaptability (6 items), and Self-esteem (8 items). Each item is scored on a likert scale from -3 (decreases) to + 3 (increases). The total score is the sum of all 26 items, ranging from -78 to 78. A higher positive score indicates more positive impact. A negative score indicates negative impact. The differences between the measurements taken at the end of 2nd week (end of baseline) and the end of 8th week (end of intervention period) are reported here to show the intervention effect.
Outcome measures
| Measure |
Arm 1: Control Group
Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
|
Arm 2: Instruction Group
n=10 Participants
Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
|
Arm 3: Instruction + VSC Group
n=6 Participants
Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
|
|---|---|---|---|
|
Questionnaire Responses: Psychological Impacts of Assistive Devices Scale
|
—
|
11.1 units on a scale
Standard Deviation 17.7
|
-8.4 units on a scale
Standard Deviation 15.6
|
SECONDARY outcome
Timeframe: At the end of 2nd (end of baseline) week and 8th week (end of intervention period) following acquisition of wheelchairPopulation: Only the data of the participants who completed the study protocol and use the wheelchair were included in the data analysis.
This outcome was measured in three aspects: Physical Independence, Cognitive Independence, and Mobility, using the three of the subscales of Craig Handicap Assessment and Reporting Technique Scale. The scores of each subscale has to be calculated with specific formula and weight based on the manual. The range of each subscale score are: Physical Independence: 28-100; Cognitive Independence: 15-100; and Mobility: 16-100. A higher score indicates greater independence. The analyzed results of the difference between the measurements at the end of 2nd week and 8th week were shown here.
Outcome measures
| Measure |
Arm 1: Control Group
Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
|
Arm 2: Instruction Group
n=10 Participants
Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
|
Arm 3: Instruction + VSC Group
n=6 Participants
Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
|
|---|---|---|---|
|
Questionnaire Responses: Independence in Community
Phy. Independence: Difference
|
—
|
9.5 units on a scale
Standard Deviation 55.6
|
8.6 units on a scale
Standard Deviation 49.2
|
|
Questionnaire Responses: Independence in Community
Cog. Independence: Difference
|
—
|
19.3 units on a scale
Standard Deviation 38.2
|
-11.7 units on a scale
Standard Deviation 18.3
|
|
Questionnaire Responses: Independence in Community
Mobility: Difference
|
—
|
0 units on a scale
Standard Deviation 22.5
|
0.5 units on a scale
Standard Deviation 17.2
|
Adverse Events
Control Group
Instruction Group
Instruction and Virtual Coach Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Clinical Coordinator
Human Engineering Reserach Laboratories
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place