Trial Outcomes & Findings for PainTracker Self-Manager: a Web-based Platform to Promote and Track Chronic Pain Self-management (NCT NCT03045081)
NCT ID: NCT03045081
Last Updated: 2019-11-12
Results Overview
Pain self-efficacy questionnaire (PSEQ); scores range from 0 to 60, with higher scores meaning greater self-efficacy (i.e., better outcome)
COMPLETED
NA
99 participants
3 months and 6 months
2019-11-12
Participant Flow
A controlled, sequential, nonrandomized study design was used. For first 6 months of enrollment, assessment procedures for the control group were conducted, during which the Web-based PTSM platform for the intervention phase of the study was developed. During the second 6 months, patients were enrolled in the intervention group.
Participant milestones
| Measure |
Usual Care
Patients receive outcome tracking tool, PainTracker, but no additional web-based support for self-management
|
PainTracker Self-Manager
Patients are invited to complete the web-based PainTracker Self-Manager and interact with a nurse care manager who supports chronic pain self-management
PainTracker Self-Manager: Interactive web-based educational and assessment program supported by a nurse care manager
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
48
|
|
Overall Study
COMPLETED
|
45
|
37
|
|
Overall Study
NOT COMPLETED
|
6
|
11
|
Reasons for withdrawal
| Measure |
Usual Care
Patients receive outcome tracking tool, PainTracker, but no additional web-based support for self-management
|
PainTracker Self-Manager
Patients are invited to complete the web-based PainTracker Self-Manager and interact with a nurse care manager who supports chronic pain self-management
PainTracker Self-Manager: Interactive web-based educational and assessment program supported by a nurse care manager
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
11
|
Baseline Characteristics
PainTracker Self-Manager: a Web-based Platform to Promote and Track Chronic Pain Self-management
Baseline characteristics by cohort
| Measure |
Usual Care
n=51 Participants
Patients receive outcome tracking tool, PainTracker, but no additional web-based support for self-management
|
PainTracker Self-Manager
n=48 Participants
Patients are invited to complete the web-based PainTracker Self-Manager and interact with a nurse care manager who supports chronic pain self-management
PainTracker Self-Manager: Interactive web-based educational and assessment program supported by a nurse care manager
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
44 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
47.23 years
STANDARD_DEVIATION 13.95 • n=5 Participants
|
45.29 years
STANDARD_DEVIATION 14.34 • n=7 Participants
|
46.29 years
STANDARD_DEVIATION 14.10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
51 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Pain Self-Efficacy Questionnaire (PSEQ)
|
24.74 score on a scale
STANDARD_DEVIATION 12.71 • n=5 Participants
|
24.43 score on a scale
STANDARD_DEVIATION 12.78 • n=7 Participants
|
24.59 score on a scale
STANDARD_DEVIATION 14.10 • n=5 Participants
|
|
Chronic Pain Acceptance Questionnaire (CPAQ)
CPAQ - Activity Engagement Subscale
|
29.26 score on a scale
STANDARD_DEVIATION 11.55 • n=5 Participants
|
29.48 score on a scale
STANDARD_DEVIATION 11.87 • n=7 Participants
|
29.37 score on a scale
STANDARD_DEVIATION 11.65 • n=5 Participants
|
|
Chronic Pain Acceptance Questionnaire (CPAQ)
CPAQ - Pain Willingness Subscale
|
20.22 score on a scale
STANDARD_DEVIATION 8.05 • n=5 Participants
|
19.65 score on a scale
STANDARD_DEVIATION 6.91 • n=7 Participants
|
19.94 score on a scale
STANDARD_DEVIATION 7.47 • n=5 Participants
|
|
Perceived Efficacy in Patient-Physician Interactions (PEPPI-5)
|
17.39 score on a scale
STANDARD_DEVIATION 4.76 • n=5 Participants
|
17.83 score on a scale
STANDARD_DEVIATION 4.91 • n=7 Participants
|
17.61 score on a scale
STANDARD_DEVIATION 4.82 • n=5 Participants
|
|
Pain severity, Enjoyment of life interference, General activity interference (PEG)
|
6.82 score on a scale
STANDARD_DEVIATION 1.95 • n=5 Participants
|
6.99 score on a scale
STANDARD_DEVIATION 1.77 • n=7 Participants
|
6.90 score on a scale
STANDARD_DEVIATION 1.86 • n=5 Participants
|
|
Satisfaction with pain treatment
|
4.39 units on a scale
STANDARD_DEVIATION 2.62 • n=5 Participants
|
4.15 units on a scale
STANDARD_DEVIATION 2.41 • n=7 Participants
|
4.28 units on a scale
STANDARD_DEVIATION 2.51 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months and 6 monthsPopulation: Analyzed number from those who provided data at all 3 time points (0, 3 months, 6 months.); published manuscript describes methodology for assessing change over time in outcomes between the two groups (generalized estimating equations), using data from (1) all enrolled participants and (2) only participants who provided data at all time points.
Pain self-efficacy questionnaire (PSEQ); scores range from 0 to 60, with higher scores meaning greater self-efficacy (i.e., better outcome)
Outcome measures
| Measure |
Usual Care
n=45 Participants
Patients receive outcome tracking tool, PainTracker, but no additional web-based support for self-management
|
PainTracker Self-Manager
n=37 Participants
Patients are invited to complete the web-based PainTracker Self-Manager and interact with a nurse care manager who supports chronic pain self-management
PainTracker Self-Manager: Interactive web-based educational and assessment program supported by a nurse care manager
|
|---|---|---|
|
Chronic Pain Self-efficacy
3 months
|
27.33 score on a scale
Standard Deviation 14.71
|
33.66 score on a scale
Standard Deviation 12.28
|
|
Chronic Pain Self-efficacy
6 months
|
28.39 score on a scale
Standard Deviation 13.68
|
35.57 score on a scale
Standard Deviation 12.29
|
SECONDARY outcome
Timeframe: 3 months and 6 monthsPopulation: While participants may have provided data at all time points, they may have not provided sufficient data to calculate a score on this measure.
Chronic Pain Acceptance Questionnaire with 2 subscales: Activity Engagement and Pain Willingness. Scores on the "activity engagement" subscale range from 0 to 66; scores on the "pain willingness" subscale range from 0 to 54; higher scores denote greater chronic pain acceptance.
Outcome measures
| Measure |
Usual Care
n=45 Participants
Patients receive outcome tracking tool, PainTracker, but no additional web-based support for self-management
|
PainTracker Self-Manager
n=37 Participants
Patients are invited to complete the web-based PainTracker Self-Manager and interact with a nurse care manager who supports chronic pain self-management
PainTracker Self-Manager: Interactive web-based educational and assessment program supported by a nurse care manager
|
|---|---|---|
|
Chronic Pain Acceptance
CPAQ-Activity Engagement; 3 months
|
31.05 score on a scale
Standard Deviation 11.22
|
36.36 score on a scale
Standard Deviation 11.00
|
|
Chronic Pain Acceptance
CPAQ-Activity Engagement; 6 months
|
32.91 score on a scale
Standard Deviation 10.21
|
38.00 score on a scale
Standard Deviation 9.62
|
|
Chronic Pain Acceptance
CPAQ-Pain Willingness; 3 months
|
20.69 score on a scale
Standard Deviation 8.98
|
23.06 score on a scale
Standard Deviation 7.56
|
|
Chronic Pain Acceptance
CPAQ-Pain Willingness; 6 months
|
21.00 score on a scale
Standard Deviation 8.16
|
23.83 score on a scale
Standard Deviation 6.87
|
SECONDARY outcome
Timeframe: 3 months and 6 monthsPopulation: While participants may have provided data at all time points, they may have not provided sufficient data to calculate a score on this measure.
Perceived efficacy in patient-physician interactions (PEPPI). Sum scores range from 5 to 25 with higher scores denoting greater perceived efficacy in patient-physician interactions.
Outcome measures
| Measure |
Usual Care
n=45 Participants
Patients receive outcome tracking tool, PainTracker, but no additional web-based support for self-management
|
PainTracker Self-Manager
n=37 Participants
Patients are invited to complete the web-based PainTracker Self-Manager and interact with a nurse care manager who supports chronic pain self-management
PainTracker Self-Manager: Interactive web-based educational and assessment program supported by a nurse care manager
|
|---|---|---|
|
Patient-physician Interactions
3 months
|
17.53 score on a scale
Standard Deviation 4.61
|
19.22 score on a scale
Standard Deviation 3.89
|
|
Patient-physician Interactions
6 months
|
17.75 score on a scale
Standard Deviation 5.23
|
20.03 score on a scale
Standard Deviation 5.02
|
SECONDARY outcome
Timeframe: 3 months and 6 monthsPopulation: While participants may have provided outcome data at all time points, they may have not provided satisfaction data for this item within 2 months of primary outcome measure collection.
Patient satisfaction with care process. Note that we elected to evaluate patient satisfaction with their pain treatment in general, as opposed to the PTSM process specifically, in order to compare satisfaction between the study groups. Patient satisfaction was rated on an 11-point rating scale from 0 "extremely dissatisfied" to 10 "extremely satisfied"; higher scores denote higher satisfaction with pain treatment.
Outcome measures
| Measure |
Usual Care
n=51 Participants
Patients receive outcome tracking tool, PainTracker, but no additional web-based support for self-management
|
PainTracker Self-Manager
n=47 Participants
Patients are invited to complete the web-based PainTracker Self-Manager and interact with a nurse care manager who supports chronic pain self-management
PainTracker Self-Manager: Interactive web-based educational and assessment program supported by a nurse care manager
|
|---|---|---|
|
Patient Satisfaction
3 months
|
5.07 score on a scale
Standard Deviation 2.49
|
5.39 score on a scale
Standard Deviation 2.47
|
|
Patient Satisfaction
6 months
|
5.27 score on a scale
Standard Deviation 2.88
|
6.36 score on a scale
Standard Deviation 2.21
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: While providers were informed of study and coaching progress, we did not formally enroll providers in the study.
Provider satisfaction with care process and PTSM
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months and 6 monthsPopulation: While participants may have provided outcome data at all time points, they may have not provided sufficient data for on this scale within 2 months of primary outcome measure collection.
Pain and pain interference were evaluated using the 3-item PEG scale. The pain intensity item was rated on an 11-point numeric rating scale, from 0 "no pain" to 10 "pain as bad as you can imagine." Interference (with enjoyment of life and general activity) were rated from 0 "does not interfere" to 10 "completely interferes." The PEG total (mean) score ranges from 0 to 10, where higher scores denote greater pain intensity and interference.
Outcome measures
| Measure |
Usual Care
n=51 Participants
Patients receive outcome tracking tool, PainTracker, but no additional web-based support for self-management
|
PainTracker Self-Manager
n=47 Participants
Patients are invited to complete the web-based PainTracker Self-Manager and interact with a nurse care manager who supports chronic pain self-management
PainTracker Self-Manager: Interactive web-based educational and assessment program supported by a nurse care manager
|
|---|---|---|
|
Pain Severity, Enjoyment of Life Interference, General Activity Interference (PEG)
3 months
|
6.83 score on a scale
Standard Deviation 2.35
|
6.06 score on a scale
Standard Deviation 1.93
|
|
Pain Severity, Enjoyment of Life Interference, General Activity Interference (PEG)
6 months
|
6.51 score on a scale
Standard Deviation 1.94
|
6.06 score on a scale
Standard Deviation 1.96
|
Adverse Events
Usual Care
PainTracker Self-Manager
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dale J. Langford, PhD; Research Assistant Professor
University of Washington
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place