Clinical trial NCT03962491: Mobile-Based Contingency Management to Promote Daily Self-monitoring in Primary Care Patients
Official title: Using Mobile-based Contingency Management to Promote Daily Self-monitoring of Pain Severity and Prescription Opioid Use in a Primary Care Sample of Chronic Pain Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Chronic
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-05-24
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Daily Self-monitoring Surveys Completed
timeFrame: 28-day daily survey period
measure: Longest Period of Sustained Adherence to Daily Survey Completion
timeFrame: 28-day daily survey period
Secondary outcomes:
measure: Daily Survey Completion Time
timeFrame: 28-day daily survey period
measure: CM App Acceptability
timeFrame: 28-day follow-up
Other outcomes:
measure: Agreement Between Daily Survey and 28-day Follow-up Reports of Alcohol Use
timeFrame: 28-day daily survey period to 28-day follow-up
measure: Agreement Between Daily Survey and 28-day Follow-up Reports of Rx Opioid Use
timeFrame: 28-day daily survey period to 28-day follow-up
measure: Agreement Between Daily Survey and 28-day Follow-up Reports of Rx Benzodiazepine Use
timeFrame: 28-day daily survey period to 28-day follow-up
measure: Agreement Between Daily Survey and 28-day Follow-up Reports of Marijuana Use
timeFrame: 28-day daily survey period to 28-day follow-up
measure: Agreement Between Daily Survey and 28-day Follow-up Reports of Cannabidiol Use
timeFrame: 28-day daily survey period to 28-day follow-up
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Dace Svikis, PhD
role: PRINCIPAL_INVESTIGATOR
References: