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Mobile-Based Contingency Management to Promote Daily Self-monitoring in Primary Care Patients (ProMPT)

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ClinicalTrials.gov Identifier: NCT03962491
Recruitment Status : Not yet recruiting
First Posted : May 24, 2019
Last Update Posted : June 18, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Virginia Commonwealth University

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).

Condition or disease Intervention/treatment Phase
Pain, Chronic Behavioral: Daily Self-Monitoring Surveys + Contingency Management Behavioral: Daily Self-Monitoring Surveys Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Daily Self-Monitoring Surveys
Asked to complete daily self-monitoring surveys.
Behavioral: 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.
Behavioral: 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.




Primary Outcome Measures :
  1. Number of daily self-monitoring surveys completed [ Time Frame: 28-day daily survey period ]
    Number of days daily surveys completed

  2. 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


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. Daily survey completion time [ Time Frame: 28-day daily survey period ]
    Mean time to complete daily surveys

  7. CM app acceptability [ Time Frame: 28-day follow-up ]
    Mean CM app acceptability survey ratings



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03962491


Contacts
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Contact: Kathryn Polak 804-628-6486 polakkm@vcu.edu
Contact: Dace Svikis, PhD 804-827-1184 dssvikis@vcu.edu

Locations
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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Dace Svikis, PhD Virginia Commonwealth University

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03962491     History of Changes
Other Study ID Numbers: HM20013828
1R36DA046671 ( U.S. NIH Grant/Contract )
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms