Connected Health to Decrease Opioid Use in Patients With Chronic Pain

NCT04013529 | Completed Results

• 1 other identifier: 01758
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this pilot study to evaluate if behavioral incentives applied at the VA Medical Center can appreciably increase participation in activities that promote mobility, and subsequently reduce pain severity and opioid use.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (2)

• Activity Participation

  Stanford Exercise Questionnaire; min score = 0, max score = 180; higher scores = better outcome

  12 weeks

• Increased Mobility

  steps per day measured by wearable step tracker at 12 weeks

  12 weeks

Secondary Outcomes (3)

• Daily Opioid Use

  12 weeks

• Physical Function

  12 weeks

• Pain Severity

  12 weeks

Study Arms (2)

Control

PLACEBO COMPARATOR

Participate in technology-enabled care without regret lottery

Behavioral: Way to Health technology enhanced care

Experimental

EXPERIMENTAL

Participate in technology-enabled care with regret lottery

Behavioral: Regret lottery; Behavioral: Way to Health technology enhanced care

Interventions

Regret lottery BEHAVIORAL

Subjects who achieve step goals are entered into a lottery in which they can win a financial incentive of $30 or $100.

Experimental

Way to Health technology enhanced care BEHAVIORAL

Subjects receive text reminders to reach activity goals.

Control; Experimental

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic non-malignant pain
• High dose opioid therapy
• Possession of activated cell phone with text messaging capabilities
• Willingness to comply with study requirements

You may not qualify if:

• Pain of malignant origin
• Sensory impairments precluding use of text messaging and activity tracker
• Physical disability precluding improvements in physical activity

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Corporal Michael Cresenz VA Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Compton P, Chaiyachati KH, Dicks T, Medvedeva E, Chhabra M. A randomized controlled trial to evaluate a behavioral economic strategy for improving mobility in veterans with chronic pain. PLoS One. 2021 Oct 11;16(10):e0257320. doi: 10.1371/journal.pone.0257320. eCollection 2021.

  PMID: 34634064 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Although subjects were blinded to group assignment, it is possible that those in the intervention arm communicated their potential to receive payment to those in the control arm who did not have the same benefit, which may have served as a disincentive for controls to engage in physical activity. Also, subjects in both groups received large numbers of text messages over the study period and may have found the messaging burdensome and thus stopped reading or responding to them as anticipated.

Results Point of Contact

• Title: Manik Chhabra
• Organization: Corporal Michael J. Crescenz VA Medical Center

manik.chhabra@va.gov

(215) 823-5800

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 9, 2019
• Study Start: August 31, 2018
• Primary Completion: September 15, 2020
• Study Completion: September 15, 2020
• Last Updated: October 27, 2021
• Results First Posted: October 27, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)