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| ID | Type | Description | Link |
|---|---|---|---|
| 1R36DA046671 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily Self-Monitoring Surveys | Other | Asked to complete daily self-monitoring surveys. |
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| Daily Self-Monitoring Surveys + Contingency Management | Experimental | Asked to complete daily self-monitoring surveys, with opportunity for monetary rewards. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daily Self-Monitoring Surveys + Contingency Management | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Daily Self-monitoring Surveys Completed | Number of days daily surveys completed | 28-day daily survey period |
| Longest Period of Sustained Adherence to Daily Survey Completion | Largest number of consecutive days wherein daily surveys were completed | 28-day daily survey period |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Survey Completion Time | Mean time to complete daily surveys | 28-day daily survey period |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dace Svikis, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Daily Self-Monitoring Surveys + Contingency Management |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Daily Self-monitoring Surveys Completed | Number of days daily surveys completed | Posted | Mean | Standard Deviation | Surveys completed | 28-day daily survey period |
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None - adverse event data was not collected
Adverse event data was not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathryn Polak, PhD | Virginia Commonwealth University | (804) 827-1184 | polakkm@vcu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 10, 2020 | Oct 3, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 10, 2020 | Oct 3, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Daily Self-Monitoring Surveys | Behavioral | 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. |
|
| 28-day follow-up |
| 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 |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Longest Period of Sustained Adherence to Daily Survey Completion | Largest number of consecutive days wherein daily surveys were completed | Posted | Mean | Standard Deviation | number of days | 28-day daily survey period |
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| Secondary | Daily Survey Completion Time | Mean time to complete daily surveys | Posted | Mean | Standard Deviation | minutes | 28-day daily survey period |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 28-day follow-up |
|
|
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| Other Pre-specified | Agreement Between Daily Survey and 28-day Follow-up Reports of Alcohol Use | Not Posted | 28-day daily survey period to 28-day follow-up | Participants |
| Other Pre-specified | Agreement Between Daily Survey and 28-day Follow-up Reports of Rx Opioid Use | Not Posted | 28-day daily survey period to 28-day follow-up | Participants |
| Other Pre-specified | Agreement Between Daily Survey and 28-day Follow-up Reports of Rx Benzodiazepine Use | Not Posted | 28-day daily survey period to 28-day follow-up | Participants |
| Other Pre-specified | Agreement Between Daily Survey and 28-day Follow-up Reports of Marijuana Use | Not Posted | 28-day daily survey period to 28-day follow-up | Participants |
| Other Pre-specified | Agreement Between Daily Survey and 28-day Follow-up Reports of Cannabidiol Use | Not Posted | 28-day daily survey period to 28-day follow-up | Participants |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Useful |
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| Appealing |
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| Bothersome |
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| Willing to use |
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| Help you cope with pain |
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