Condition or disease | Intervention/treatment | Phase |
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Chronic Pain | Behavioral: Regret lottery Behavioral: Way to Health technology enhanced care | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Actual 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 |
Actual Primary Completion Date : | September 15, 2020 |
Actual Study Completion Date : | September 15, 2020 |
Arm | Intervention/treatment |
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Placebo Comparator: Control
Participate in technology-enabled care without regret lottery
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Behavioral: Way to Health technology enhanced care
Subjects receive text reminders to reach activity goals.
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Experimental: Experimental
Participate in technology-enabled care with regret lottery
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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.
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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 |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
Corporal Michael Cresenz VA Medical Center | |
Philadelphia, Pennsylvania, United States, 19104 |
Tracking Information | |||||
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First Submitted Date ICMJE | July 2, 2019 | ||||
First Posted Date ICMJE | July 9, 2019 | ||||
Last Update Posted Date | October 9, 2020 | ||||
Actual Study Start Date ICMJE | August 31, 2018 | ||||
Actual Primary Completion Date | September 15, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Connected Health to Decrease Opioid Use in Patients With Chronic Pain | ||||
Official Title ICMJE | Connected Health to Decrease Opioid Use in Patients With Chronic Pain | ||||
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment |
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Condition ICMJE | Chronic Pain | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
40 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | September 15, 2020 | ||||
Actual Primary Completion Date | September 15, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04013529 | ||||
Other Study ID Numbers ICMJE | 01758 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | University of Pennsylvania | ||||
Study Sponsor ICMJE | University of Pennsylvania | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | University of Pennsylvania | ||||
Verification Date | October 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |