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Connected Health to Decrease Opioid Use in Patients With Chronic Pain

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ClinicalTrials.gov Identifier: NCT04013529
Recruitment Status : Recruiting
First Posted : July 9, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: Regret lottery Behavioral: Way to Health technology enhanced care Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Connected Health to Decrease Opioid Use in Patients With Chronic Pain
Actual Study Start Date : August 31, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Placebo Comparator: Control
Participate in technology-enabled care without regret lottery
Behavioral: Way to Health technology enhanced care
Subjects receive text reminders to reach activity goals.

Experimental: Experimental
Participate in technology-enabled care with regret lottery
Behavioral: Regret lottery
Subjects who achieve step goals are entered into a lottery in which they can win a financial incentive of $30 or $100.

Behavioral: Way to Health technology enhanced care
Subjects receive text reminders to reach activity goals.




Primary Outcome Measures :
  1. Activity participation and increased mobility [ Time Frame: 12 weeks ]
    measured by the Stanford Exercise Questionnaire

  2. Increased mobility [ Time Frame: 12 weeks ]
    measured by wearable step tracker


Secondary Outcome Measures :
  1. Opioid use [ Time Frame: 12 weeks ]
    measured by medication adherence

  2. Opioid use [ Time Frame: 12 weeks ]
    measured by pill counts

  3. physical function [ Time Frame: 12 weeks ]
    measured by PROMIS (Patient-reported Outcomes Measurement Information System) pain interference tool, which is a 6-item self-report survey; each item is scored from 1 (not at all) to 5 (very much), thus scores ranged from 6 to 30, with higher score indicating more pain interference.

  4. pain severity [ Time Frame: 12 weeks ]
    measured by PROMIS (Patient-reported Outcomes Measurement Information System) pain severity tool, which is a 3-item self-report survey; each item is scored from 1 (no pain at all) to 5 (very severity), thus scores ranged from 3 to 15, with higher score indicating more severe pain.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04013529


Contacts
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Contact: Tanisha Dicks 215-823-5800 ext 7157 tanisha.dicks@va.gov

Locations
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United States, Pennsylvania
Corporal Michael Cresenz VA Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Tanisha Dicks       tanisha.dicks@va.gov   
Sponsors and Collaborators
University of Pennsylvania

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04013529     History of Changes
Other Study ID Numbers: 01758
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plan to share IPD

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

Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms