- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03962491
Mobile-Based Contingency Management to Promote Daily Self-monitoring in Primary Care Patients (ProMPT)
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 Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Daily Self-Monitoring Surveys
Asked to complete 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.
|
Experimental: Daily Self-Monitoring Surveys + Contingency Management
Asked to complete daily self-monitoring surveys, with opportunity for monetary rewards.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Daily Self-monitoring Surveys Completed
Time Frame: 28-day daily survey period
|
Number of days daily surveys completed
|
28-day daily survey period
|
Longest Period of Sustained Adherence to Daily Survey Completion
Time Frame: 28-day daily survey period
|
Largest number of consecutive days wherein daily surveys were completed
|
28-day daily survey period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Daily Survey Completion Time
Time Frame: 28-day daily survey period
|
Mean time to complete daily surveys
|
28-day daily survey period
|
CM App Acceptability
Time Frame: 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.
|
28-day follow-up
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
28-day daily survey period to 28-day follow-up
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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
|
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
|
28-day daily survey period to 28-day follow-up
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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
|
28-day daily survey period to 28-day follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM20013828
- 1R36DA046671 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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