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

NCT03962491 | Completed Results

• 2 other identifiers: HM200138281R36DA046671
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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).

Conditions

Pain, Chronic

Outcome Measures

Primary Outcomes (2)

• Number of Daily Self-monitoring Surveys Completed

  Number of days daily surveys completed

  28-day daily survey period

• 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 Outcomes (2)

• Daily Survey Completion Time

  28-day daily survey period

• CM App Acceptability

  28-day follow-up

Other Outcomes (5)

• Agreement Between Daily Survey and 28-day Follow-up Reports of Alcohol Use

  28-day daily survey period to 28-day follow-up

• Agreement Between Daily Survey and 28-day Follow-up Reports of Rx Opioid Use

  28-day daily survey period to 28-day follow-up

• Agreement Between Daily Survey and 28-day Follow-up Reports of Rx Benzodiazepine Use

  28-day daily survey period to 28-day follow-up

Study Arms (2)

Daily Self-Monitoring Surveys

OTHER

Asked to complete daily self-monitoring surveys.

Behavioral: Daily Self-Monitoring Surveys

Daily Self-Monitoring Surveys + Contingency Management

EXPERIMENTAL

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

Behavioral: Daily Self-Monitoring Surveys + Contingency Management

Interventions

Daily Self-Monitoring Surveys + Contingency Management BEHAVIORAL

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 + Contingency Management

Daily Self-Monitoring Surveys BEHAVIORAL

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.

Daily Self-Monitoring Surveys

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Kathryn Polak, PhD
• Organization: Virginia Commonwealth University

polakkm@vcu.edu

(804) 827-1184

Study Officials

• Dace Svikis, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 24, 2019
• Study Start: January 24, 2020
• Primary Completion: April 14, 2021
• Study Completion: April 14, 2021
• Last Updated: December 7, 2022
• Results First Posted: December 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)