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Trial Outcomes & Findings for The Effect of Questionnaire Content on Measures of Pain Intensity, Magnitude of Disability, and Symptoms of Depression in Patients With Arm Illness (NCT NCT02209259)

NCT ID: NCT02209259

Last Updated: 2018-05-14

Results Overview

A computerized assessment of upper extremity physical function measured at enrollment. The average T score of the U.S. population is 50, so the T score reported compares the study population to the U.S. population, where a T score greater than 50 is better than the average and a T score less than 50 is worse than the average.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

168 participants

Primary outcome timeframe

1day

Results posted on

2018-05-14

Participant Flow

Participant milestones

Participant milestones
Measure
Standard PCS
The first intervention group will be comprised of patients who will complete the standard PCS.
Positively-adjusted PCS
The second intervention group will be comprised of patients who will complete a positively-adjusted version of the PCS.
Control
The third group (the control arm) will not complete the PCS.
Overall Study
STARTED
56
56
56
Overall Study
COMPLETED
56
56
56
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Questionnaire Content on Measures of Pain Intensity, Magnitude of Disability, and Symptoms of Depression in Patients With Arm Illness

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Standard PCS
n=56 Participants
The first intervention group will be comprised of patients who will complete the standard PCS.
Positively-adjusted PCS
n=56 Participants
The second intervention group will be comprised of patients who will complete a positively-adjusted version of the PCS.
Control
n=56 Participants
The third group (the control arm) will not complete the PCS.
Total
n=168 Participants
Total of all reporting groups
Age, Continuous
53 years
STANDARD_DEVIATION 16 • n=5 Participants
51 years
STANDARD_DEVIATION 18 • n=7 Participants
56 years
STANDARD_DEVIATION 15 • n=5 Participants
52 years
STANDARD_DEVIATION 17 • n=4 Participants
Sex: Female, Male
Female
27 Participants
n=5 Participants
34 Participants
n=7 Participants
28 Participants
n=5 Participants
89 Participants
n=4 Participants
Sex: Female, Male
Male
29 Participants
n=5 Participants
22 Participants
n=7 Participants
28 Participants
n=5 Participants
79 Participants
n=4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Asian
4 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
8 Participants
n=4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Black or African American
3 Participants
n=5 Participants
2 Participants
n=7 Participants
1 Participants
n=5 Participants
6 Participants
n=4 Participants
Race (NIH/OMB)
White
47 Participants
n=5 Participants
46 Participants
n=7 Participants
50 Participants
n=5 Participants
143 Participants
n=4 Participants
Race (NIH/OMB)
More than one race
2 Participants
n=5 Participants
6 Participants
n=7 Participants
3 Participants
n=5 Participants
11 Participants
n=4 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Region of Enrollment
United States
56 participants
n=5 Participants
56 participants
n=7 Participants
56 participants
n=5 Participants
168 participants
n=4 Participants

PRIMARY outcome

Timeframe: 1day

A computerized assessment of upper extremity physical function measured at enrollment. The average T score of the U.S. population is 50, so the T score reported compares the study population to the U.S. population, where a T score greater than 50 is better than the average and a T score less than 50 is worse than the average.

Outcome measures

Outcome measures
Measure
Standard PCS
n=56 Participants
The first intervention group will be comprised of patients who will complete the standard PCS.
Positively-adjusted PCS
n=56 Participants
The second intervention group will be comprised of patients who will complete a positively-adjusted version of the PCS.
Control
n=56 Participants
The third group (the control arm) will not complete the PCS.
Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity
39 T-score
Standard Deviation 9.8
43 T-score
Standard Deviation 8.1
41 T-score
Standard Deviation 11

SECONDARY outcome

Timeframe: 1 day

10 point pain scale, where 0 is no pain and 10 is the most pain

Outcome measures

Outcome measures
Measure
Standard PCS
n=56 Participants
The first intervention group will be comprised of patients who will complete the standard PCS.
Positively-adjusted PCS
n=56 Participants
The second intervention group will be comprised of patients who will complete a positively-adjusted version of the PCS.
Control
n=56 Participants
The third group (the control arm) will not complete the PCS.
Pain Intensity
3.5 units on a scale
Standard Deviation 3.0
3.5 units on a scale
Standard Deviation 2.9
3.3 units on a scale
Standard Deviation 2.9

SECONDARY outcome

Timeframe: 1 day

A computerized assessment of depression measured at enrollment. The average T score of the U.S. population is 50, so the T score reported compares the study population to the U.S. population, where a T score greater than 50 is worse than the average and a T score less than 50 is better than the average.

Outcome measures

Outcome measures
Measure
Standard PCS
n=56 Participants
The first intervention group will be comprised of patients who will complete the standard PCS.
Positively-adjusted PCS
n=56 Participants
The second intervention group will be comprised of patients who will complete a positively-adjusted version of the PCS.
Control
n=56 Participants
The third group (the control arm) will not complete the PCS.
Patient Reported Outcomes Measurement Information System (PROMIS) Depression
47 T-score
Standard Deviation 8.4
48 T-score
Standard Deviation 7.9
48 T-score
Standard Deviation 8.5

Adverse Events

Standard PCS

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Positively-adjusted PCS

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control

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

Taylor Pong

Massachusetts General Hospital

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place