SMART app wearable for Pain

Phase-Based Estimates
1
Effectiveness
1
Safety
Duke University, Durham, NC
SMART app wearable - Other
Eligibility
Any Age
All Sexes
Eligible conditions
Pain

Study Summary

This study is evaluating whether a mobile app can help track pain levels in patients with sickle cell disease, oncology patients, and bone marrow transplant patients.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether SMART app wearable will improve 1 primary outcome and 3 secondary outcomes in patients with Pain. Measurement will happen over the course of 7 days.

7 days
magnitude of change in pain scores
patient/family satisfaction scores as measured by feasibility survey
time of movement during hospitalization
time to discontinuation of the IV PCA with opioid medication

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Control
SMART app wearable device

This trial requires 100 total participants across 2 different treatment groups

This trial involves 2 different treatments. SMART App Wearable is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

SMART app wearable device
Other
Patients will be given a wearable such as a Microsoft Band accelerometer to track movement, heart rate, galvanic skin response and sleep, which will be collected in combination with the data from the SMART visual dashboard. Data will be sent to the SMART dashboard as well as stored on the iPad/iPod touch via software from the manufacturer. Participants having a "wearable device" will receive the education intervention (such as haptic prompted texts that state 'try and walk today', 'have you had enough water today', 'make sure to take deep breaths').
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 7 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 7 days for reporting.

Closest Location

Duke University - Durham, NC

Eligibility Criteria

This trial is for patients born any sex of any age. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Any patient 8-80 years old with a past medical history for a chronic disease (such as sickle cell disease), cancer (solid tumor, lymphoma, brain tumor), or currently undergoing bone marrow transplant
Currently admitted to the hospital
Have a current diagnosis which includes pain for which they are being treated

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for pain?

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Patients with low [back pain](https://www.withpower.com/clinical-trials/back-pain) (LBP) are commonly prescribed physiotherapy, chiropractic care, or massage therapy. For severe disabling cases, most patients receive antidepressants or antidepressant combination therapy, and some are prescribed opioid medications. Patients with osteoarthritis (OA) are commonly prescribed physical and occupational therapy and are often indicated to receive pain medications.

Unverified Answer

What is pain?

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Pain may be seen in the context of a complex interconnective system that incorporates both the sensory-discriminative and affective components from both the ascending spinothalamic and descending somato-motoneural pathways. Understanding the basic mechanisms that mediate the perception of pain should lead to new insights into its pathophysiology and potentially to novel approaches to the treatment.

Unverified Answer

What are the signs of pain?

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The causes of pain are often identifiable during physical examinations. It may be helpful for doctors to consider other diagnoses, in particular when a history of pain from earlier in life and for other diseases coincides.

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What causes pain?

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Pain can be categorized as primary and secondary. Primary pain (pain that has no known cause) typically comes as a result of injury, inflammatory or acute conditions. Secondary pain (pain that has a known cause) is commonly due to a chronic disease process, or it is a consequence of illness. Primary pain often responds to treatment, but secondary pain usually is not treated and usually worsens with time. A comprehensive assessment of primary and secondary pain is important, particularly when there are other factors that can affect diagnosis or management of pain.

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How many people get pain a year in the United States?

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The percentage of adults suffering from any degree of chronic pain is around 17%, with only about 14% of these being moderate or severe in nature. Overall, chronic pain occurs in around 5% of the population yearly in the United States.

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Can pain be cured?

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Although there are no medications approved in the US for treatment of chronic osteoarthritis pain, there are a number of medications approved by the Food and Drug Administration for cancer pain. The evidence for these agents is not excellent, but at least one of the therapies is recommended by current guidelines.

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What are the common side effects of smart app wearable?

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The side effects of wearable apps include pain and skin irritation. The duration of their use is a cause for concern because an increasing proportion of patients continue using the wearable on a daily basis.

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What are the latest developments in smart app wearable for therapeutic use?

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It is suggested that an advanced sensor is essential to make an accurate monitoring of users’ physical activity and also the application of an appropriate adaptive response to prevent any further hazards, even with a small-motor assistance.

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Is smart app wearable typically used in combination with any other treatments?

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A smart phone application is usually used in combination with another therapeutic device. However, we have not observed any significant interaction effect with the smart phone application.

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Does pain run in families?

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The occurrence of a range of complaints among siblings with varying levels of functional impairment supports the possibility that inheritance may play a role in the pathophysiology of chronic pain. Data from a recent study also point towards a role for genetically mediated predisposition by members of the same family, although this remains speculative at present.

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Has smart app wearable proven to be more effective than a placebo?

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Overall, the data from the small pilot study are encouraging and future large-scale validation is feasible. We conclude that the data show that the Smart App can be a promising tool to treat pain and is worthy of further evaluation.

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What is smart app wearable?

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This is the first in vivo human study of a smart band. We assessed the feasibility of using a smart band for wireless monitoring and real-time analysis of HR and RPP.

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