N/A
N=81
Mobile-Based Contingency Management to Promote Daily Self-monitoring in Primary Care Patients
Pain, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT03962491 ↗Enrolled (actual)
81
Serious AEs
—
Results posted
Dec 2022
Primary outcome: Primary: Number of Daily Self-monitoring Surveys Completed — 23.06; 26.09 Surveys completed
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Daily Self-Monitoring Surveys + Contingency Management (Behavioral); Daily Self-Monitoring Surveys (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Daily Self-monitoring Surveys Completed |
23.06; 26.09 | — |
| PRIMARY Longest Period of Sustained Adherence to Daily Survey Completion |
17.11; 22.07 | — |
| SECONDARY Daily Survey Completion Time |
8.71; 5.78 | — |
| SECONDARY CM App Acceptability |
7.71; 6.67; 7.78; 7.31; 6.58; 6.82 | — |
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).
Eligibility Criteria
Inclusion Criteria
- at least 18 years of age;
- own a study-compatible smartphone (iPhone or Android device);
- report non-cancer related chronic pain (consistent daily pain) for 3 months or greater;
- able to provide informed consent for study participation;
- used prescription opioids in the past 30 days; and
- having ever been prescribed 1 or more opioid medication(s) for pain management.
Exclusion Criteria
- currently pregnant;
- 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
- visual impairment or motor impairment that would interfere with use of a smartphone.
Data sourced from ClinicalTrials.gov (NCT03962491). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.