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Clinical Trials/NCT04013529
NCT04013529CompletedNot Applicable

Connected Health to Decrease Opioid Use in Patients With Chronic Pain

University of Pennsylvania1 site in 1 country40 target enrollmentStarted: August 31, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Increased Mobility

Study Overview

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.

Detailed Description

Chronic pain is a highly prevalent and costly condition in the US. An estimated 88.5 million adults suffer from daily pain, resulting in estimated cost of $500- 635 biJlion due to lost productivity, and $261-300 billion in health care expenditures. To manage their chronic pain, 5 to 8 million Americans take an opioid medication daily. Yet , the risks associated with ongoing opioid prescription , including overdose, abuse and diversion, temper their analgesic effects.

Opioids are not more effective in the treatment of chronic pain compared with non-opioid approaches. Current guidelines have adapted to the evidence, recommending opioid-sparing approaches for treating patients with chronic pain, and tapering for those on higher doses to safer levels of use. Tapering opioids, however, requires replacing them with effective non-opioid strategies. Improving mobility has been shown to improve pain and decrease medication use among patients chronically prescribed opiates. Concurrently, financial incentives and the use of behavioral incentives have been shown to promote mobility.

Appreciating the gains in health outcomes that can be made with "connected health" approaches, we propose a novel pilot study designed to evaluate if technology enabled care (TEC) strategies and financial incentives can improve patient mobility in our chronic pain population, reduce pain and decrease opioid use . Our primary aim is to determine if chronic pain patients who receive TEC-enhanced treatment with financial incentives demonstrate increased participation in activities that promote mobility (physical therapy, yoga, tai chi) in comparison to patients receiving usual care. Secondary outcomes will include whether increased activity participation also reduces pain severity and opioid use, and improves function and increases the number of daily steps taken. The results of this pilot will enable us to determine what strategies are effective at increasing mobility and if these gains translate into reduced pain and decreased opioid use.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

Control

Placebo Comparator

Participate in technology-enabled care without regret lottery

Intervention: Way to Health technology enhanced care (Behavioral)

Experimental

Experimental

Participate in technology-enabled care with regret lottery

Intervention: Regret lottery (Behavioral)

Experimental

Experimental

Participate in technology-enabled care with regret lottery

Intervention: Way to Health technology enhanced care (Behavioral)

Outcomes

Primary Outcomes

Increased Mobility

Time Frame: 12 weeks

steps per day measured by wearable step tracker at 12 weeks

Activity Participation

Time Frame: 12 weeks

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

Secondary Outcomes

  • Physical Function(12 weeks)
  • Daily Opioid Use(12 weeks)
  • Pain Severity(12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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