Pain, Chronic
Conditions
Brief summary
This project examines the efficacy and feasibility of contingency management (CM), delivered using a novel, fully automated CM app (DynamiCare Rewards), to promote daily self-monitoring of pain symptom severity and related variables (e.g., mood, sleep), as well as Rx opioid, alcohol, marijuana, cannabidiol (CBD), and Rx benzodiazepine use in a sample of chronic pain patients. The project will conduct a 2-arm randomized clinical trial (RCT) comparing those receiving reinforcement escalating with continuous performance of the target behavior (CM group) vs those asked to complete the survey but will not be incentivized (C group).
Detailed description
Prescription (Rx) opioid misuse is a significant public health problem and the CDC has declared an opioid epidemic (Dowell, Haegerich, & Chou, 2016). Chronic pain patients, often prescribed opioids for pain management, represent a particularly vulnerable population (e.g., Boscarino et al., 2011). Responsible opioid prescribing depends on effective identification of misuse and comprehensive understanding of pain-related variables (Dowell, Haegerich, & Chou, 2016). Self-report tracking via smartphone apps is a promising solution, but difficulties with adherence have been found to impede the use of remote self-monitoring among chronic pain patients (e.g., Jamison et al., 2016), even with the inclusion of non-monetary rewards (Jamison et al., 2017). One robust strategy for improving adherence is contingency management (CM). While CM has been widely used in research, the translation to clinical practice has met with resistance due, in large part, to practical barriers (e.g., Carroll, 2014). As a Stage 1 behavioral therapies development project (Rounsaville et al., 2001), the goal of this study is to examine the efficacy and feasibility of CM, delivered using a novel, fully automated CM app (DynamiCare), to promote daily self-monitoring of pain symptom severity and related variables (e.g., mood, sleep), as well as Rx opioid, alcohol, marijuana, cannabidiol (CBD), and Rx benzodiazepine use in a sample of chronic pain patients. The target behavior will be objectively defined as completing daily self-monitoring surveys via the app for which those randomized to CM will earn incentives. Participants will complete baseline assessment, followed by random assignment to either the experimental (CM) or control (C) group. All participants will then download the app onto their smartphone and be provided with instruction in its use. Based on the work by Petry et al. (2005) and Olmstead and Petry (2009), the CM group will receive reinforcement escalating with continuous performance of the target behavior while the C group will be asked to complete the survey, but will not receive incentivizes. Both groups will receive reminders to complete the daily survey. Follow-up assessments (including behavioral and psychological measures) will occur at intervention completion (28-days post-randomization) and both CM and C group members will be compensated for their time and effort. The specific aims of this project are to: 1) Compare number of completed daily self-monitoring surveys in CM and C groups; 2) Compare longest sustained period of daily survey completion in CM and C groups; 3) Examine agreement between daily survey and 28-day follow-up visit reports of Rx opioid, alcohol, marijuana, cannabidiol (CBD), and Rx benzodiazepine use in CM and C groups; 4) Examine feasibility and acceptability of CM app implementation targeting self-monitoring of pain severity, related factors, and Rx opioid, alcohol, marijuana, cannabidiol (CBD), and Rx benzodiazepine use; and 5) Estimate effect-size to be used to perform power analyses and sample size calculations as part of the design of a larger RCT.
Interventions
Asked to complete a brief (5-minute) survey with questions related to pain experience and related measures every day for 28 days using the DynamiCare smartphone app, with the opportunity for monetary rewards for completing daily surveys.
Asked to complete a brief (5-minute) survey with questions related to pain experience and related measures every day for 28 days using the DynamiCare smartphone app.
Sponsors
Study design
Eligibility
Inclusion criteria
1. at least 18 years of age; 2. own a study-compatible smartphone (iPhone or Android device); 3. report non-cancer related chronic pain (consistent daily pain) for 3 months or greater; 4. able to provide informed consent for study participation; 5. used prescription opioids in the past 30 days; and 6. having ever been prescribed 1 or more opioid medication(s) for pain management.
Exclusion criteria
1. currently pregnant; 2. presenting with language barriers, cognitive impairment, or serious medical or psychiatric illness that in the opinion of the Investigator would preclude them from providing informed consent or participating in the study; and 3. visual impairment or motor impairment that would interfere with use of a smartphone.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Daily Self-monitoring Surveys Completed | 28-day daily survey period | Number of days daily surveys completed |
| Longest Period of Sustained Adherence to Daily Survey Completion | 28-day daily survey period | Largest number of consecutive days wherein daily surveys were completed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CM App Acceptability | 28-day follow-up | CM App Acceptability was measured using a 8 item scale asking about experiences using the app. Each item was rated on a 0 - 10 Likert scale with higher scores indicating more positive responses. Scores for each item are reported separately. |
| Daily Survey Completion Time | 28-day daily survey period | Mean time to complete daily surveys |
Other
| Measure | Time frame |
|---|---|
| Agreement Between Daily Survey and 28-day Follow-up Reports of Rx Benzodiazepine Use | 28-day daily survey period to 28-day follow-up |
| Agreement Between Daily Survey and 28-day Follow-up Reports of Marijuana Use | 28-day daily survey period to 28-day follow-up |
| Agreement Between Daily Survey and 28-day Follow-up Reports of Cannabidiol Use | 28-day daily survey period to 28-day follow-up |
| Agreement Between Daily Survey and 28-day Follow-up Reports of Alcohol Use | 28-day daily survey period to 28-day follow-up |
| Agreement Between Daily Survey and 28-day Follow-up Reports of Rx Opioid Use | 28-day daily survey period to 28-day follow-up |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Daily Self-Monitoring Surveys Asked to complete daily self-monitoring surveys.
Daily Self-Monitoring Surveys: Asked to complete a brief (5-minute) survey with questions related to pain experience and related measures every day for 28 days using the DynamiCare smartphone app. | 35 |
| Daily Self-Monitoring Surveys + Contingency Management Asked to complete daily self-monitoring surveys, with opportunity for monetary rewards.
Daily Self-Monitoring Surveys + Contingency Management: Asked to complete a brief (5-minute) survey with questions related to pain experience and related measures every day for 28 days using the DynamiCare smartphone app, with the opportunity for monetary rewards for completing daily surveys. | 46 |
| Total | 81 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 5 |
Baseline characteristics
| Characteristic | Daily Self-Monitoring Surveys | Total | Daily Self-Monitoring Surveys + Contingency Management |
|---|---|---|---|
| Age, Continuous | 45.71 years STANDARD_DEVIATION 12.39 | 44.76 years STANDARD_DEVIATION 14.55 | 44.02 years STANDARD_DEVIATION 16.12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 7 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 72 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) White | 32 Participants | 72 Participants | 40 Participants |
| Region of Enrollment United States | 35 participants | 81 participants | 46 participants |
| Sex/Gender, Customized Female | 28 Participants | 61 Participants | 33 Participants |
| Sex/Gender, Customized Male | 7 Participants | 19 Participants | 12 Participants |
| Sex/Gender, Customized Other | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Longest Period of Sustained Adherence to Daily Survey Completion
Largest number of consecutive days wherein daily surveys were completed
Time frame: 28-day daily survey period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Daily Self-Monitoring Surveys | Longest Period of Sustained Adherence to Daily Survey Completion | 17.11 number of days | Standard Deviation 9.36 |
| Daily Self-Monitoring Surveys + Contingency Management | Longest Period of Sustained Adherence to Daily Survey Completion | 22.07 number of days | Standard Deviation 7.76 |
Number of Daily Self-monitoring Surveys Completed
Number of days daily surveys completed
Time frame: 28-day daily survey period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Daily Self-Monitoring Surveys | Number of Daily Self-monitoring Surveys Completed | 23.06 Surveys completed | Standard Deviation 6.97 |
| Daily Self-Monitoring Surveys + Contingency Management | Number of Daily Self-monitoring Surveys Completed | 26.09 Surveys completed | Standard Deviation 3.85 |
CM App Acceptability
CM App Acceptability was measured using a 8 item scale asking about experiences using the app. Each item was rated on a 0 - 10 Likert scale with higher scores indicating more positive responses. Scores for each item are reported separately.
Time frame: 28-day follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daily Self-Monitoring Surveys | CM App Acceptability | Useful | 6.58 score on a scale | Standard Deviation 2.17 |
| Daily Self-Monitoring Surveys | CM App Acceptability | Bothersome | 6.95 score on a scale | Standard Deviation 2.16 |
| Daily Self-Monitoring Surveys | CM App Acceptability | Overall satisfaction | 7.78 score on a scale | Standard Deviation 1.48 |
| Daily Self-Monitoring Surveys | CM App Acceptability | Willing to use | 7.09 score on a scale | Standard Deviation 2.43 |
| Daily Self-Monitoring Surveys | CM App Acceptability | Appealing | 7.13 score on a scale | Standard Deviation 2.03 |
| Daily Self-Monitoring Surveys | CM App Acceptability | Help you cope with pain | 4.25 score on a scale | Standard Deviation 2.15 |
| Daily Self-Monitoring Surveys | CM App Acceptability | Easy to use | 7.71 score on a scale | Standard Deviation 1.11 |
| Daily Self-Monitoring Surveys + Contingency Management | CM App Acceptability | Help you cope with pain | 4.87 score on a scale | Standard Deviation 2.45 |
| Daily Self-Monitoring Surveys + Contingency Management | CM App Acceptability | Easy to use | 6.67 score on a scale | Standard Deviation 1.23 |
| Daily Self-Monitoring Surveys + Contingency Management | CM App Acceptability | Overall satisfaction | 7.31 score on a scale | Standard Deviation 1.49 |
| Daily Self-Monitoring Surveys + Contingency Management | CM App Acceptability | Useful | 6.82 score on a scale | Standard Deviation 2.3 |
| Daily Self-Monitoring Surveys + Contingency Management | CM App Acceptability | Appealing | 7.50 score on a scale | Standard Deviation 1.69 |
| Daily Self-Monitoring Surveys + Contingency Management | CM App Acceptability | Bothersome | 5.50 score on a scale | Standard Deviation 3.04 |
| Daily Self-Monitoring Surveys + Contingency Management | CM App Acceptability | Willing to use | 8.11 score on a scale | Standard Deviation 1.05 |
Daily Survey Completion Time
Mean time to complete daily surveys
Time frame: 28-day daily survey period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Daily Self-Monitoring Surveys | Daily Survey Completion Time | 8.71 minutes | Standard Deviation 33.03 |
| Daily Self-Monitoring Surveys + Contingency Management | Daily Survey Completion Time | 5.78 minutes | Standard Deviation 9.66 |
Agreement Between Daily Survey and 28-day Follow-up Reports of Alcohol Use
Time frame: 28-day daily survey period to 28-day follow-up
Agreement Between Daily Survey and 28-day Follow-up Reports of Cannabidiol Use
Time frame: 28-day daily survey period to 28-day follow-up
Agreement Between Daily Survey and 28-day Follow-up Reports of Marijuana Use
Time frame: 28-day daily survey period to 28-day follow-up
Agreement Between Daily Survey and 28-day Follow-up Reports of Rx Benzodiazepine Use
Time frame: 28-day daily survey period to 28-day follow-up
Agreement Between Daily Survey and 28-day Follow-up Reports of Rx Opioid Use
Time frame: 28-day daily survey period to 28-day follow-up