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

Primary Purpose

Pain, Chronic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Daily Self-Monitoring Surveys + Contingency Management
Daily Self-Monitoring Surveys
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Daily Self-Monitoring Surveys

Daily Self-Monitoring Surveys + Contingency Management

Arm Description

Asked to complete daily self-monitoring surveys.

Asked to complete daily self-monitoring surveys, with opportunity for monetary rewards.

Outcomes

Primary Outcome Measures

Number of Daily Self-monitoring Surveys Completed
Number of days daily surveys completed
Longest Period of Sustained Adherence to Daily Survey Completion
Largest number of consecutive days wherein daily surveys were completed

Secondary Outcome Measures

Daily Survey Completion Time
Mean time to complete daily surveys
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.

Full Information

First Posted
May 22, 2019
Last Updated
November 11, 2022
Sponsor
Virginia Commonwealth University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03962491
Brief Title
Mobile-Based Contingency Management to Promote Daily Self-monitoring in Primary Care Patients
Acronym
ProMPT
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 24, 2020 (Actual)
Primary Completion Date
April 14, 2021 (Actual)
Study Completion Date
April 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Daily Self-Monitoring Surveys
Arm Type
Other
Arm Description
Asked to complete daily self-monitoring surveys.
Arm Title
Daily Self-Monitoring Surveys + Contingency Management
Arm Type
Experimental
Arm Description
Asked to complete daily self-monitoring surveys, with opportunity for monetary rewards.
Intervention Type
Behavioral
Intervention Name(s)
Daily Self-Monitoring Surveys + Contingency Management
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Daily Self-Monitoring Surveys
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Daily Self-monitoring Surveys Completed
Description
Number of days daily surveys completed
Time Frame
28-day daily survey period
Title
Longest Period of Sustained Adherence to Daily Survey Completion
Description
Largest number of consecutive days wherein daily surveys were completed
Time Frame
28-day daily survey period
Secondary Outcome Measure Information:
Title
Daily Survey Completion Time
Description
Mean time to complete daily surveys
Time Frame
28-day daily survey period
Title
CM App Acceptability
Description
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.
Time Frame
28-day follow-up
Other Pre-specified Outcome Measures:
Title
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
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dace Svikis, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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