Mitigation of Major Hip Injury Due to Fall With a Smart Belt

Study Overview
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Brief Summary
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Multi-center, comparative, non-significant risk adaptive study with retrospective controls. After providing informed consent and being screened for eligibility, intervention subjects will be prescribed and provided an appropriately sized Tango Belt. The subject must demonstrate a minimum of 64% adherence to the use of the Tango Belt within 14 days of initiation to fully enroll in the study. Upon demonstration of at least minimum adherence, the subject will be provided the Tango Belt to wear continuously for at least 6 months, except during bathing, device charging, and as deemed by clinical staff. The study will investigate the safety and effectiveness of the Tango Belt with the primary and secondary endpoints being taken every 3 months and at the end of the study run time from the electronic medical record. Additionally, ancillary endpoints on adverse events and device performance will be gathered.

Detailed Description
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This is a multi-center, comparative, adaptive, non-significant risk clinical trial conducted in the United States to assess the safety and efficacy of the Tango Belt within senior care settings. Effectiveness of the Tango Belt will be determined by analysis of evidence for the Tango Belt as an adjunctive intervention to the standard-of-care (SOC) to mitigate major hip injuries from falls in an older adult population at-risk for fall injury as the primary endpoint. Performance of the Tango Belt to mitigate fall injuries that result in hip fracture, emergency room visits, and hospitalizations will be secondary endpoints. The performance of the device is determined by the comparison of the proportion of fall-related major hip injuries in the intervention group as compared to the proportion of fall-related major hip injuries in a retrospective control group utilizing only SOC. SOC utilization will be verified for each clinical site enrolled. An adaptive trial design will be utilized to allow an initial efficacy target to be evaluated at 6 months; if the initial target is not met, then a second cohort of sites and subjects will be enrolled for an additional 6 months to allow a lower efficacy target to be evaluated. Safety of the device will be determined by analysis of adverse events as an ancillary endpoint.

Official Title
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Mitigation of Major Hip Injury Due to Fall in an At-Risk, Older Adult Population With a Wearable Smart Belt

Conditions
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Hip Injuries, Fractures, Hip, Fall Injury, Fall Risk, Osteoporosis, Osteoporosis Risk

Intervention / Treatment
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* Device: Tango Belt


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 65 years or older; Have experienced a fall-related fracture after age 50 -OR- Have experienced one or more falls in the 12-months prior to consent and have a diagnosis of osteoporosis, osteopenia, or prescribed osteoporosis medication. Independently or with staff or caregiver assistance, able to transfer between surfaces (e.g., to or from a bed, chair, wheelchair, toilet, standing position) or walk or move between locations (use of an assistive device such as a walker is acceptable); Have a waist circumference between 29 - 50 inches (63.5 - 127 cm); Able to comply with required study procedures and follow-up schedule as determined by the Study Investigator; Are under the care of the Investigational organization; Provides consent or their legally authorized representative provides consent on subject's behalf Exclusion Criteria: Age 64 years or less; Participation in a different clinical investigation that can conflict with this clinical study as determined by the Study Investigator and approved by the Sponsor; Total dependence on staff or caregiver assistance to be able to transfer between surfaces (e.g., to or from a bed, chair, wheelchair, toilet, standing position) and walk and move between locations; Use of other devices or interventions outside of SOC (Standard of care) for fall risk management during study participation without Sponsor approval; Unable to comply with required study procedures and follow-up schedule as determined by the Study Investigator; Does not provide consent, or legally authorized representative does not provide consent

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>The intervention group will be assigned a Tango Belt to be worn around the waist for up to 24 hours a day (removed for bathing, charging of device and upon request) for 6 months. The Tango Belt (the Device) is a wearable belt designed to enable safer mobility of geriatric individuals (≥ 65 years of age) at risk for fall injury by mitigating major hip injuries due to falls by deploying an airbag around the hips upon sensing a serious hip-impacting fall-in-progress to protect the hips from ground impact forces. | Device: Tango Belt<br>* The Tango Belt is a patient-contacting electronic device made out of medical grade plastics and biocompatible fabrics worn around the waist. The Tango Belt contains a fall-in-progress detection algorithm which can detect a serious hip-impacting fall-in-progress using built-in sensors and deploy an automotive-grade cold-gas airbag to protect the hips from ground impact forces. When connected to Wi-Fi, the Tango Belt can send automated fall and impact alerts to caregivers and Healthcare Providers (HCPs) while recording motion and event data, which can then be analyzed for usage-based metrics viewable via a companion mobile app and/or desktop app. Alerts are sent in the form of short message service (SMS) texts and emails to alert recipients designated in the mobile or desktop Companion App. The Tango Belt can also detect non-serious hip-impacting or non-hip impacting falls in which the wearer may have incurred a minor injury (i.e., not a major hip injury) and/or may be unable to get up.<br>|
| No Intervention: Control Group<br>The the clinical site's electronic medical record (EMR) database will be reviewed determine their long-term care patient population's initial eligibility for meeting the study inclusion criteria beginning at the time frame 6 months prior to the institutional review board (IRB) approval date. Subjects eligible for the control group must meet the requirements of the inclusion and exclusion criteria except for the waist circumference and need for consent. Eligible subjects' electronic health records will be mined for the baseline, midpoint, and final study metrics. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major hip injuries due to fall | The proportion of major hip injuries due to fall in the subjects receiving SOC as compared to subjects receiving SOC plus the Tango Belt. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hip fractures due to fall | The number of hip fractures due to fall in the subjects receiving SOC as compared to subjects receiving SOC plus the Tango Belt. | 6 months | 
| Number of emergency department visits due to fall | The number of emergency department visits due to fall in the subjects receiving SOC as compared to subjects receiving SOC plus the Tango Belt. | 6 months | 
| Number of hospitalizations due to fall | The number of admissions to a hospital due to fall in the subjects receiving SOC as compared to subjects receiving SOC plus the Tango Belt. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fall risk, Fall injury, Major hip injury, Hip fracture