Trial Outcomes & Findings for Connected Health to Decrease Opioid Use in Patients With Chronic Pain (NCT NCT04013529)
NCT ID: NCT04013529
Last Updated: 2021-10-27
Results Overview
Stanford Exercise Questionnaire; min score = 0, max score = 180; higher scores = better outcome
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
12 weeks
Results posted on
2021-10-27
Participant Flow
Participant milestones
| Measure |
Control
Participate in technology-enabled care without regret lottery
Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals.
|
Experimental
Participate in technology-enabled care with regret lottery
Regret lottery: Subjects who achieve step goals are entered into a lottery in which they can win a financial incentive of $30 or $100.
Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Control
Participate in technology-enabled care without regret lottery
Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals.
|
Experimental
Participate in technology-enabled care with regret lottery
Regret lottery: Subjects who achieve step goals are entered into a lottery in which they can win a financial incentive of $30 or $100.
Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Connected Health to Decrease Opioid Use in Patients With Chronic Pain
Baseline characteristics by cohort
| Measure |
Control
n=20 Participants
Participate in technology-enabled care without regret lottery
Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals.
|
Experimental
n=20 Participants
Participate in technology-enabled care with regret lottery
Regret lottery: Subjects who achieve step goals are entered into a lottery in which they can win a financial incentive of $30 or $100.
Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.2 years
STANDARD_DEVIATION 11.0 • n=93 Participants
|
59.6 years
STANDARD_DEVIATION 13.5 • n=4 Participants
|
57.4 years
STANDARD_DEVIATION 12.3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=93 Participants
|
20 participants
n=4 Participants
|
40 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 weeksStanford Exercise Questionnaire; min score = 0, max score = 180; higher scores = better outcome
Outcome measures
| Measure |
Control
n=19 Participants
Participate in technology-enabled care without regret lottery
Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals.
|
Experimental
n=19 Participants
Participate in technology-enabled care with regret lottery
Regret lottery: Subjects who achieve step goals are entered into a lottery in which they can win a financial incentive of $30 or $100.
Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals.
|
|---|---|---|
|
Activity Participation
|
156.0 score on a scale
Standard Deviation 116.8
|
135.8 score on a scale
Standard Deviation 123.0
|
PRIMARY outcome
Timeframe: 12 weekssteps per day measured by wearable step tracker at 12 weeks
Outcome measures
| Measure |
Control
n=19 Participants
Participate in technology-enabled care without regret lottery
Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals.
|
Experimental
n=19 Participants
Participate in technology-enabled care with regret lottery
Regret lottery: Subjects who achieve step goals are entered into a lottery in which they can win a financial incentive of $30 or $100.
Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals.
|
|---|---|---|
|
Increased Mobility
|
4313 steps per day
Standard Deviation 4231
|
4075 steps per day
Standard Deviation 5598
|
SECONDARY outcome
Timeframe: 12 weeksmeasured by opioid morphine mg equivalents used each day (MED)
Outcome measures
| Measure |
Control
n=19 Participants
Participate in technology-enabled care without regret lottery
Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals.
|
Experimental
n=19 Participants
Participate in technology-enabled care with regret lottery
Regret lottery: Subjects who achieve step goals are entered into a lottery in which they can win a financial incentive of $30 or $100.
Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals.
|
|---|---|---|
|
Daily Opioid Use
|
167.2 morphine mg equivalents per day (MED)
Standard Deviation 244.4
|
31.9 morphine mg equivalents per day (MED)
Standard Deviation 35.53
|
SECONDARY outcome
Timeframe: 12 weeksmeasured by interference with walking on PROMIS (Patient-reported Outcomes Measurement Information System) pain interference tool, which is a 6-item self-report survey; each item is scored from 1 (not at all) to 5 (very much), thus scores ranged from 6 to 30, with higher score indicating more pain interference.
Outcome measures
| Measure |
Control
n=19 Participants
Participate in technology-enabled care without regret lottery
Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals.
|
Experimental
n=19 Participants
Participate in technology-enabled care with regret lottery
Regret lottery: Subjects who achieve step goals are entered into a lottery in which they can win a financial incentive of $30 or $100.
Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals.
|
|---|---|---|
|
Physical Function
|
25.4 units on a scale
Standard Deviation 10.94
|
24.2 units on a scale
Standard Deviation 12.49
|
SECONDARY outcome
Timeframe: 12 weeksmeasured by pain severity on PROMIS (Patient-reported Outcomes Measurement Information System) pain severity tool, which is a 3-item self-report survey; each item is scored from 1 (no pain at all) to 5 (very severity), thus scores ranged from 3 to 15, with higher score indicating more severe pain.
Outcome measures
| Measure |
Control
n=19 Participants
Participate in technology-enabled care without regret lottery
Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals.
|
Experimental
n=19 Participants
Participate in technology-enabled care with regret lottery
Regret lottery: Subjects who achieve step goals are entered into a lottery in which they can win a financial incentive of $30 or $100.
Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals.
|
|---|---|---|
|
Pain Severity
|
6.7 units on a scale
Standard Deviation 1.63
|
6.8 units on a scale
Standard Deviation 1.95
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental
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
Manik Chhabra
Corporal Michael J. Crescenz VA Medical Center
Phone: (215) 823-5800
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place