Trial Outcomes & Findings for Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools (NCT NCT02464449)
NCT ID: NCT02464449
Last Updated: 2023-07-27
Results Overview
The Roland Morris Disability Questionnaire (RMDQ) is a 24-item checklist designed for patients to identify the level of disability and functional status associated with chronic low back pain. Patients are instructed to endorse items that describe their functional status that day. Scores range from 0-24, with higher scores indicating more disability.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
278 participants
Primary outcome timeframe
3 and 6 months post enrollment
Results posted on
2023-07-27
Participant Flow
Participant milestones
| Measure |
AI CBT
AI CBT engine will make recommendations to step-down or step-up intensity of CBT FU based on what patient reports and what other similar patients report. Stepped care model.
Behavioral: AI-CBT: AI CBT engine will make recommendations to step-down or step-up intensity of CBT follow-up based on what patient reports and what other similar patients report. Stepped care model.
|
Standard Telephone CBT
Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook.
Behavioral: Standard Telephone CBT: Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook.
|
|---|---|---|
|
Overall Study
STARTED
|
166
|
112
|
|
Overall Study
COMPLETED
|
151
|
100
|
|
Overall Study
NOT COMPLETED
|
15
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools
Baseline characteristics by cohort
| Measure |
AI CBT
n=166 Participants
AI CBT engine will make recommendations to step-down or step-up intensity of CBT FU based on what patient reports and what other similar patients report. Stepped care model.
Behavioral: AI-CBT: AI CBT engine will make recommendations to step-down or step-up intensity of CBT follow-up based on what patient reports and what other similar patients report. Stepped care model.
|
Standard Telephone CBT
n=112 Participants
Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook.
Behavioral: Standard Telephone CBT: Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook.
|
Total
n=278 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.8 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
65.6 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
63.9 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
145 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
248 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
160 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
265 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
27 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
131 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
225 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Pain-related Disability
|
13.7 units on a scale
STANDARD_DEVIATION 4.1 • n=5 Participants
|
13.5 units on a scale
STANDARD_DEVIATION 4.2 • n=7 Participants
|
13.6 units on a scale
STANDARD_DEVIATION 4.1 • n=5 Participants
|
|
Global Pain Intensity
|
6.2 units on a scale
STANDARD_DEVIATION 1.6 • n=5 Participants
|
6.3 units on a scale
STANDARD_DEVIATION 1.4 • n=7 Participants
|
6.2 units on a scale
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Pain-Related Interference
|
4.9 units on a scale
STANDARD_DEVIATION 2.2 • n=5 Participants
|
5.0 units on a scale
STANDARD_DEVIATION 2.1 • n=7 Participants
|
4.9 units on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Depression Symptom Severity
|
6.3 units on a scale
STANDARD_DEVIATION 5.2 • n=5 Participants
|
6.6 units on a scale
STANDARD_DEVIATION 5.1 • n=7 Participants
|
6.5 units on a scale
STANDARD_DEVIATION 5.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 and 6 months post enrollmentPopulation: The number analyzed in rows differs because some participants did not complete the questionnaire at all time points.
The Roland Morris Disability Questionnaire (RMDQ) is a 24-item checklist designed for patients to identify the level of disability and functional status associated with chronic low back pain. Patients are instructed to endorse items that describe their functional status that day. Scores range from 0-24, with higher scores indicating more disability.
Outcome measures
| Measure |
AI CBT
n=151 Participants
AI CBT engine will make recommendations to step-down or step-up intensity of CBT FU based on what patient reports and what other similar patients report. Stepped care model.
Behavioral: AI-CBT: AI CBT engine will make recommendations to step-down or step-up intensity of CBT follow-up based on what patient reports and what other similar patients report. Stepped care model.
|
Standard Telephone CBT
n=100 Participants
Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook.
Behavioral: Standard Telephone CBT: Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook.
|
|---|---|---|
|
Pain-related Disability
3 months post enrollment
|
11.0 units on a scale
Standard Deviation 6.1
|
11.3 units on a scale
Standard Deviation 5.1
|
|
Pain-related Disability
6 months post enrollment
|
11.0 units on a scale
Standard Deviation 5.9
|
12.6 units on a scale
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: 3 and 6 months post enrollmentPopulation: The number analyzed in rows differs because some participants did not complete the questionnaire at all time points.
An 11-point Numeric Rating Scale (NRS) for pain severity, with 0 representing "No pain" and 10 representing the "Worst pain imaginable." Patients were asked to rate their level of pain on average in the last week.
Outcome measures
| Measure |
AI CBT
n=151 Participants
AI CBT engine will make recommendations to step-down or step-up intensity of CBT FU based on what patient reports and what other similar patients report. Stepped care model.
Behavioral: AI-CBT: AI CBT engine will make recommendations to step-down or step-up intensity of CBT follow-up based on what patient reports and what other similar patients report. Stepped care model.
|
Standard Telephone CBT
n=100 Participants
Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook.
Behavioral: Standard Telephone CBT: Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook.
|
|---|---|---|
|
Global Pain Intensity
3 months post enrollment
|
5.1 units on a scale
Standard Deviation 2.0
|
5.0 units on a scale
Standard Deviation 1.8
|
|
Global Pain Intensity
6 months post enrollment
|
5.3 units on a scale
Standard Deviation 1.9
|
5.7 units on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: 3 and 6 months post enrollmentPopulation: The number analyzed in rows differs because some participants did not complete the questionnaire at all time points.
Pain-related interference was measured using the Brief Pain Inventory - Short Form (BPI). Scores range from 0-10, with higher scores indicating more interference.
Outcome measures
| Measure |
AI CBT
n=151 Participants
AI CBT engine will make recommendations to step-down or step-up intensity of CBT FU based on what patient reports and what other similar patients report. Stepped care model.
Behavioral: AI-CBT: AI CBT engine will make recommendations to step-down or step-up intensity of CBT follow-up based on what patient reports and what other similar patients report. Stepped care model.
|
Standard Telephone CBT
n=100 Participants
Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook.
Behavioral: Standard Telephone CBT: Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook.
|
|---|---|---|
|
Pain-Related Interference
3 months post enrollment
|
3.9 units on a scale
Standard Deviation 2.4
|
3.8 units on a scale
Standard Deviation 2.1
|
|
Pain-Related Interference
6 months post enrollment
|
3.9 units on a scale
Standard Deviation 2.3
|
4.5 units on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 3 and 6 months post enrollmentPopulation: The number analyzed in rows differs because some participants did not complete the questionnaire at all time points.
Depression symptom severity was assessed using the 9-item Patient Health Questionnaire (PHQ-9). Scores range from 0-27, with higher scores indicating more depression symptom severity.
Outcome measures
| Measure |
AI CBT
n=151 Participants
AI CBT engine will make recommendations to step-down or step-up intensity of CBT FU based on what patient reports and what other similar patients report. Stepped care model.
Behavioral: AI-CBT: AI CBT engine will make recommendations to step-down or step-up intensity of CBT follow-up based on what patient reports and what other similar patients report. Stepped care model.
|
Standard Telephone CBT
n=100 Participants
Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook.
Behavioral: Standard Telephone CBT: Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook.
|
|---|---|---|
|
Depression Symptom Severity
3 months post enrollment
|
6.7 units on a scale
Standard Deviation 5.3
|
6.7 units on a scale
Standard Deviation 5.1
|
|
Depression Symptom Severity
6 months post enrollment
|
6.8 units on a scale
Standard Deviation 5.1
|
7.5 units on a scale
Standard Deviation 6.0
|
Adverse Events
AI CBT
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Telephone CBT
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AI CBT
n=166 participants at risk
AI CBT engine will make recommendations to step-down or step-up intensity of CBT FU based on what patient reports and what other similar patients report. Stepped care model.
Behavioral: AI-CBT: AI CBT engine will make recommendations to step-down or step-up intensity of CBT follow-up based on what patient reports and what other similar patients report. Stepped care model.
|
Standard Telephone CBT
n=112 participants at risk
Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook.
Behavioral: Standard Telephone CBT: Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.60%
1/166 • Number of events 1 • During the intervention period (approximately 10 weeks of the standard telephone CBT or the AI CBT).
|
0.00%
0/112 • During the intervention period (approximately 10 weeks of the standard telephone CBT or the AI CBT).
|
|
Vascular disorders
Stroke
|
0.60%
1/166 • Number of events 1 • During the intervention period (approximately 10 weeks of the standard telephone CBT or the AI CBT).
|
0.00%
0/112 • During the intervention period (approximately 10 weeks of the standard telephone CBT or the AI CBT).
|
|
Infections and infestations
Infection
|
1.2%
2/166 • Number of events 2 • During the intervention period (approximately 10 weeks of the standard telephone CBT or the AI CBT).
|
0.89%
1/112 • Number of events 1 • During the intervention period (approximately 10 weeks of the standard telephone CBT or the AI CBT).
|
|
Cardiac disorders
Chest pain
|
0.60%
1/166 • Number of events 1 • During the intervention period (approximately 10 weeks of the standard telephone CBT or the AI CBT).
|
0.00%
0/112 • During the intervention period (approximately 10 weeks of the standard telephone CBT or the AI CBT).
|
|
Gastrointestinal disorders
Emesis
|
0.00%
0/166 • During the intervention period (approximately 10 weeks of the standard telephone CBT or the AI CBT).
|
0.89%
1/112 • Number of events 1 • During the intervention period (approximately 10 weeks of the standard telephone CBT or the AI CBT).
|
|
General disorders
Heat stroke
|
0.00%
0/166 • During the intervention period (approximately 10 weeks of the standard telephone CBT or the AI CBT).
|
0.89%
1/112 • Number of events 1 • During the intervention period (approximately 10 weeks of the standard telephone CBT or the AI CBT).
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place