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

Pain, Chronic Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03962491
• Other study ID #: HM20013828
• Secondary ID: 1R36DA046671
• Status: Completed
• Phase: N/A
• Start date: January 24, 2020
• Est. completion date: April 14, 2021

Study information

• Verified date: November 2022
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: April 14, 2021
• Est. primary completion date: April 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Agreement Between Daily Survey and 28-day Follow-up Reports of Alcohol Use		28-day daily survey period to 28-day follow-up
Other	Agreement Between Daily Survey and 28-day Follow-up Reports of Rx Opioid Use		28-day daily survey period to 28-day follow-up
Other	Agreement Between Daily Survey and 28-day Follow-up Reports of Rx Benzodiazepine Use		28-day daily survey period to 28-day follow-up
Other	Agreement Between Daily Survey and 28-day Follow-up Reports of Marijuana Use		28-day daily survey period to 28-day follow-up
Other	Agreement Between Daily Survey and 28-day Follow-up Reports of Cannabidiol Use		28-day daily survey period to 28-day follow-up
Primary	Number of Daily Self-monitoring Surveys Completed	Number of days daily surveys completed	28-day daily survey period
Primary	Longest Period of Sustained Adherence to Daily Survey Completion	Largest number of consecutive days wherein daily surveys were completed	28-day daily survey period
Secondary	Daily Survey Completion Time	Mean time to complete daily surveys	28-day daily survey period
Secondary	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.	28-day follow-up