Trial Outcomes & Findings for Implementation of Nurse-guided Web-based Cognitive Behavioral Therapy for Pain Management (NCT NCT03927846)
NCT ID: NCT03927846
Last Updated: 2024-11-19
Results Overview
Questionnaire that measures subject pain intensity. The possible score range is 3-15, 3 being the best outcome and 15 being the worst outcome
COMPLETED
NA
60 participants
Up to Week 16
2024-11-19
Participant Flow
Participant milestones
| Measure |
Nurse Support
Participants received phone-based coaching
|
Control
No contact with the research team
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
10
|
11
|
Reasons for withdrawal
| Measure |
Nurse Support
Participants received phone-based coaching
|
Control
No contact with the research team
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
11
|
Baseline Characteristics
Implementation of Nurse-guided Web-based Cognitive Behavioral Therapy for Pain Management
Baseline characteristics by cohort
| Measure |
Nurse Support
n=30 Participants
Participants received phone-based coaching
|
Control
n=30 Participants
No contact with the research team
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.3 years
STANDARD_DEVIATION 14.9 • n=5 Participants
|
51.8 years
STANDARD_DEVIATION 20.5 • n=7 Participants
|
52.1 years
STANDARD_DEVIATION 17.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
PROMIS pain intensity
|
5.8 units on a scale
STANDARD_DEVIATION 1.6 • n=5 Participants
|
6.0 units on a scale
STANDARD_DEVIATION 1.9 • n=7 Participants
|
5.9 units on a scale
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
PROMIS pain interference
|
61.2 T-Score
STANDARD_DEVIATION 7.4 • n=5 Participants
|
62.9 T-Score
STANDARD_DEVIATION 6.5 • n=7 Participants
|
62.1 T-Score
STANDARD_DEVIATION 7.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Week 16Questionnaire that measures subject pain intensity. The possible score range is 3-15, 3 being the best outcome and 15 being the worst outcome
Outcome measures
| Measure |
Nurse Support
n=20 Participants
Participants received phone-based coaching
|
Control
n=19 Participants
No contact with the research team
|
|---|---|---|
|
PROMIS (Patient Reported-outcomes Measurement Information System) Pain Intensity
|
4.4 score on a scale
Standard Error 0.3
|
4.7 score on a scale
Standard Error 0.2
|
PRIMARY outcome
Timeframe: Up to Week 16PROMIS pain interference is a questionnaire that measures interference of pain on subject's life. The possible raw score range is 6-30. The raw score has been converted into a T score. The T score range is from 41.6 to 75.6. A t-score indicates the number of standard deviations away from the mean. A t-score of 50 is equal to the mean of a reference population. Values below 50 indicate pain interference better than the reference population and values above 50 indicate pain interference worse than the reference population.
Outcome measures
| Measure |
Nurse Support
n=20 Participants
Participants received phone-based coaching
|
Control
n=19 Participants
No contact with the research team
|
|---|---|---|
|
PROMIS Pain Interference
|
57.4 T-score
Standard Error 0.9
|
57.3 T-score
Standard Error 0.9
|
SECONDARY outcome
Timeframe: Up to Week 16The number of completed phone calls by the nurse will be recorded.
Outcome measures
| Measure |
Nurse Support
n=20 Participants
Participants received phone-based coaching
|
Control
n=19 Participants
No contact with the research team
|
|---|---|---|
|
Completed Phone Calls
|
3.5 number of phone calls
Interval 2.0 to 5.0
|
0 number of phone calls
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Week 16The number of completed learning modules per treatment arm will be recorded.
Outcome measures
| Measure |
Nurse Support
n=30 Participants
Participants received phone-based coaching
|
Control
n=30 Participants
No contact with the research team
|
|---|---|---|
|
Completed Learning Modules Per Treatment Arm
|
7 number of learning modules
Interval 1.0 to 8.0
|
8 number of learning modules
Interval 1.0 to 8.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 16This refers to the acceptability a subject has to pain self management. This would be determined by the number of subjects who answer "yes" to the question "Have you ever wondered if there is something that you could do on your own to better manage your pain?" divided by the number of patients who answered "yes" to the question "Over the last 6 months, do you have daily or almost daily pain that interfered with your general activity or enjoyment of life?"
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 16This refers to the acceptability a subject has to watching the educational video on web-based CBT. This would be determined by the number of patients who watched the video from Expectation Management and Medical Information (EMMI) divided by the number of patients who received the video from EMMI.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 16This refers to the acceptability a subject has to participating in the study. This would be determined by the number of patients who made a phone call to the research team after watching the video divided by the number of patients who watched the video.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 16This refers to whether health care personnel perceives a disruption in the clinic standard operating procedures
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 16This refers to the adoption or extent of participants' motivation to engage in the web-based CBT program. For the uptake rate, the number of times participants log in to web-based CBT will be recorded.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 16This refers to the adoption or extent of participants' motivation to engage in the web-based CBT program. Self-report frequency of practicing pain coping skills will be measured by a question scale 0-5. Higher scores denote better outcomes.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 16This refers to the adoption or extent of participants' motivation to engage in the web-based CBT program. Recorded in a question - scale 0-5. Higher scores denote better outcomes.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 16This refers to the feasibility of the web-based CBT program. The number of minutes a nurse spends on study-related phone calls and the time a nurse spends during the initial and ongoing MI training will be recorded.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 16This refers to the feasibility of the web-based CBT program. Nurses will rate perceived additional work load. Recorded using sing a scale 1-5, higher scores denotes worse outcomes.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 16This refers to the feasibility of the web-based CBT program. This scale is used to assess treatment fidelity to the principles of MI.Scale range from 5 to 25, where a score of 25 represents 100% adherence to the principles of motivational interviewing (MI).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 16This refers to the burden or utilization of health care in relation to the web-based CBT program. The mean daily dose of opioids will be recorded for all participants.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 16This refers to the burden or utilization of health care in relation to the web-based CBT program. The number of pain relevant phone calls will be recorded.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 16This refers to the burden or utilization of health care in relation to the web-based CBT program. The number of new referrals to other musculoskeletal-related specialties will be recorded.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 16This refers to the burden or utilization of health care in relation to the web-based CBT program. The number of ER visits per subject related to pain will be recorded.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 16This is a questionnaire that pertains to subject physical health. Raw summed score from 4 to 20, where 20 represents severe fatigue.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 16This is a questionnaire that pertains to subject physical health. Raw summed score from 4 to 20, where 20 represents severe physical impairment.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 16This is a questionnaire that pertains to subject physical health.Raw summed score from 4 to 20, where 20 represents severe sleep impairment.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 16This is a questionnaire that pertains to subject physical health. Raw summed score from 20 to 100, where 100 represents severely maladaptive pain behavior.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 16This is a questionnaire that pertains to subject social health. Raw summed score range from 4 to 20, where 20 represents complete inability to participate in various social functions.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 16This is a pain severity questionnaire. BPI consists of four items that are scored from 0 (no pain) to 10 (worst possible pain); the mean of this four areas is reported as the score.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 16This is a questionnaire that shows a subject's perceived interference of pain in his/her daily life. The BPI pain interference section consists of seven items that are scored from 0 (no interference) to 10 (complete interference).A pain interference score is calculated from the mean of the seven pain interference items.
Outcome measures
| Measure |
Nurse Support
n=20 Participants
Participants received phone-based coaching
|
Control
n=19 Participants
No contact with the research team
|
|---|---|---|
|
BPI Pain Interference
|
3.5 score on a scale
Standard Error 0.3
|
3.5 score on a scale
Standard Error 0.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 16This questionnaire shows the subject's perceived pain. The score is from 0-52 with 0 being the best outcome and 52 being the worst outcome.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 16This questionnaire shows how the subject rates his/her overall condition of pain from the beginning of treatment to when the questionnaire is completed. The score ranges from -5 to 5, with -5 being the worst outcome and 5 being the best outcome.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 16A questionnaire that shows patient's level of depression. Scores can be 0-24, with 0 being the best outcome and 24 being the worst. A score of 10 or greater is considered major depression. A score of 20 or more is severe major depression.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 16A questionnaire that shows how much anxiety a subject has. Scores can be 0-18. A score of 5-9 means mild anxiety. A score of 10-14 means moderate anxiety. A score of 15-18 means severe anxiety.
Outcome measures
Outcome data not reported
Adverse Events
Nurse Support
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dennis Ang, Primary Investigator
Wake Forest Health Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place