Trial Outcomes & Findings for Extending Veteran Participation in the Validation of the SCI-QOL/CAT (NCT NCT01238549)

Results Overview

Average score on a questionnaire about level of independence. The minimum score on the scale is 24.6 and the maximum is 68.9. Fifty is the average score. Values below 50 indicate a worse outcome. Values above 50 represent a better outcome.

Recruitment status

COMPLETED

Target enrollment

284 participants

Primary outcome timeframe

Baseline

Results posted on

2018-11-29

Participant Flow

Participants recruited from SCI Clinics at the James J. Peters Veterans Affairs Medical Center, Bronx, New York and the James A. Haley Veterans Hospital, Tampa, Florida. 284 participants signed consent. 248 participants completed the Quality of Life questionnaires.

Participant milestones

Participant milestones
Measure	Spinal Cord Injury Participants with SCI
Overall Study STARTED	284
Overall Study COMPLETED	248
Overall Study NOT COMPLETED	36

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Extending Veteran Participation in the Validation of the SCI-QOL/CAT

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Spinal Cord Injury n=248 Participants Participants with SCI
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	185 Participants n=5 Participants
Age, Categorical >=65 years	63 Participants n=5 Participants
Age, Continuous	56.98 years STANDARD_DEVIATION 12.56 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	236 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	218 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	50 Participants n=5 Participants
Race (NIH/OMB) White	168 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	23 Participants n=5 Participants
Region of Enrollment United States	248 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: One participant did not completed item bank or outcomes.

Average score on a questionnaire about level of independence. The minimum score on the scale is 24.6 and the maximum is 68.9. Fifty is the average score. Values below 50 indicate a worse outcome. Values above 50 represent a better outcome.

Outcome measures

Outcome measures
Measure	Spinal Cord Injury n=247 Participants Participants with SCI
SCI-QoL Independence	49.9 units on a scale Standard Deviation 10.2

SECONDARY outcome

Timeframe: Baseline

Population: One participant did not completed item bank or outcomes.

Average score on a SCI-QoL Ability to Participate in Social Roles and Activities scale. The minimum score on the scale is 25.1 and the maximum is 61.1. A higher score represents better functioning (more ability to participate in social roles and activities).

Outcome measures

Outcome measures
Measure	Spinal Cord Injury n=247 Participants Participants with SCI
SCI-QoL Ability to Participate in Social Roles and Activities	45.5 units on a scale Standard Deviation 8.0

SECONDARY outcome

Timeframe: Baseline

Average score on SCI-QoL Anxiety. The minimum score on the scale is 36.3 and the maximum is 84.2. A higher score represents more anxiety (worse functioning). A lower score represents less anxiety (better functioning).

Outcome measures

Outcome measures
Measure	Spinal Cord Injury n=248 Participants Participants with SCI
SCI-QoL Anxiety	48.3 units on a scale Standard Deviation 10.2

SECONDARY outcome

Timeframe: Baseline

Average score on SCI-QoL Bowel Management Difficulties. The minimum score on the scale is 39.2 and the maximum is 76.3. A higher score represents more bowel management difficulties (worse functioning). A lower score represents fewer bowel management difficulties (better functioning).

Outcome measures

Outcome measures
Measure	Spinal Cord Injury n=248 Participants Participants with SCI
SCI-QoL Bowel Management Difficulties	47.5 units on a scale Standard Deviation 9.8

SECONDARY outcome

Timeframe: Baseline

Average score on SCI-QoL Bladder Management Difficulties. The minimum score on the scale is 39.7 and the maximum is 76.8. A higher score represents more bladder management difficulties (worse functioning). A lower score represents fewer bladder management difficulties (better functioning).

Outcome measures

Outcome measures
Measure	Spinal Cord Injury n=248 Participants Participants with SCI
SCI-QoL Bladder Management Difficulties	50.5 units on a scale Standard Deviation 9.6

SECONDARY outcome

Timeframe: Baseline

Population: One participant did not completed item bank or outcomes.

Average score on SCI-QoL Depression. The minimum score on the scale is 38.3 and the maximum is 81.9. A higher score represents more depression (worse functioning). A lower score represents less depression (better functioning).

Outcome measures

Outcome measures
Measure	Spinal Cord Injury n=247 Participants Participants with SCI
SCI-QoL Depression	47.7 units on a scale Standard Deviation 9.9

SECONDARY outcome

Timeframe: Baseline

Average score on SCI-QoL Pain Behavior. The minimum score on the scale is 38.2 and the maximum is 76.1. A higher score represents more pain behavior (worse functioning). A lower score represents less pain behavior (better functioning).

Outcome measures

Outcome measures
Measure	Spinal Cord Injury n=248 Participants Participants with SCI
SCI-QoL Pain Behavior	53.7 units on a scale Standard Deviation 9.5

SECONDARY outcome

Timeframe: Baseline

Population: One participant did not completed item bank or outcomes.

Average score on SCI-QoL Pain Interference. The minimum score on the scale is 40.2 and the maximum is 79.7. A higher score represents more pain interference (worse functioning). A lower score represents less anxiety (better functioning).

Outcome measures

Outcome measures
Measure	Spinal Cord Injury n=247 Participants Participants with SCI
SCI-QoL Pain Interference	54.8 units on a scale Standard Deviation 10.2

SECONDARY outcome

Timeframe: Baseline

Average score on SCI-QoL Positive Affect and Well-being. The minimum score on the scale is 26.7 and the maximum is 68.6. A higher score represents more positive affect and well-being (better functioning).

Outcome measures

Outcome measures
Measure	Spinal Cord Injury n=248 Participants Participants with SCI
SCI-QoL Positive Affect and Well-being	55.7 units on a scale Standard Deviation 9.0

SECONDARY outcome

Timeframe: Baseline

Average score on SCI-QoL Resilience. The minimum score on the scale is 16.4 and the maximum is 66.4. A higher score represents more resilience (better functioning).

Outcome measures

Outcome measures
Measure	Spinal Cord Injury n=248 Participants Participants with SCI
SCI-QoL Resilience	53.9 units on a scale Standard Deviation 11.6

SECONDARY outcome

Timeframe: Baseline

Average score on SCI-QoL Satisfaction with Social Roles and Activities. The minimum score on the scale is 28.3 and the maximum is 60.5. A higher score represents more satisfaction with social roles and activities (better functioning).

Outcome measures

Outcome measures
Measure	Spinal Cord Injury n=248 Participants Participants with SCI
SCI-QoL Satisfaction With Social Roles and Activities	47.5 units on a scale Standard Deviation 6.9

SECONDARY outcome

Timeframe: Baseline

Average score on SCI-QoL Stigma. The minimum score on the scale is 37.8 and the maximum is 77.3. A higher score represents more stigma (worse functioning). A lower score represents less stigma (better functioning).

Outcome measures

Outcome measures
Measure	Spinal Cord Injury n=248 Participants Participants with SCI
SCI-QoL Stigma	50.9 units on a scale Standard Deviation 7.9

SECONDARY outcome

Timeframe: Baseline

Average score on SCI-QoL Trauma. The minimum score on the scale is 38.4 and the maximum is 85.2. A higher score represents more trauma (worse functioning). A lower score represents less trauma (better functioning).

Outcome measures

Outcome measures
Measure	Spinal Cord Injury n=248 Participants Participants with SCI
SCI-QoL Trauma	46.8 units on a scale Standard Deviation 10.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Average score on SCI-QoL Grief Loss. The minimum score on the scale is 30.9 and the maximum is 76.1. A higher score represents more grief/loss (worse functioning). A lower score represents less grief/loss (better functioning).

Outcome measures

Outcome measures
Measure	Spinal Cord Injury n=248 Participants Participants with SCI
SCI-QoL Grief Loss	46.5 units on a scale Standard Deviation 11.0

Adverse Events

Spinal Cord Injury

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ann Spungen

VAORD

Phone: 718-584-9000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place