Clinical trial NCT05245097: Mitigation of Major Hip Injury Due to Fall With a Smart Belt
Official title: Mitigation of Major Hip Injury Due to Fall in an At-Risk, Older Adult Population With a Wearable Smart Belt
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Injuries
Fractures, Hip
Fall Injury
Fall Risk
Osteoporosis
Osteoporosis Risk
Keywords: Fall risk
Fall injury
Major hip injury
Hip fracture
Lead sponsor: ActiveProtective Technologies, Inc
Sponsor class: INDUSTRY
Collaborators: name: Avania
First posted: 2022-02-17
Enrollment: 471
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Age 65 years or older;
2. 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.
3. 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);
4. Have a waist circumference between 29 - 50 inches (63.5 - 127 cm);
5. Able to comply with required study procedures and follow-up schedule as determined by the Study Investigator;
6. Are under the care of the Investigational organization;
7. Provides consent or their legally authorized representative provides consent on subject's behalf

Exclusion Criteria:

1. Age 64 years or less;
2. Participation in a different clinical investigation that can conflict with this clinical study as determined by the Study Investigator and approved by the Sponsor;
3. 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;
4. Use of other devices or interventions outside of SOC (Standard of care) for fall risk management during study participation without Sponsor approval;
5. Unable to comply with required study procedures and follow-up schedule as determined by the Study Investigator;
6. Does not provide consent, or legally authorized representative does not provide consent

Primary outcomes:
measure: Major Hip Injuries Due to Serious Hip-impacting Fall
timeFrame: 6 months
Secondary outcomes:
measure: Number of Hip Fractures Related to Fall
timeFrame: 6 months
measure: Number of Emergency Department Visits Related to Fall
timeFrame: 6 months
measure: Number of Hospitalizations Due to Fall
timeFrame: 6 months
Other outcomes:
measure: Number and Severity of Adverse Events
timeFrame: 6 months
measure: Number of Major Injuries Due to Fall
timeFrame: 6 months
measure: Rate of Fall Occurence
timeFrame: 6 months
measure: Device Wear Adherence
timeFrame: 90 days and 180 days
measure: Device Wear Compliance
timeFrame: 6 months
measure: Accuracy of Device Fall Discrimination
timeFrame: 6 months
measure: Accuracy of Study Device Airbag Deployment
timeFrame: 6 months
measure: Balance Confidence Score Changes
timeFrame: 6 months
Locations:
city: Sacramento
country: United States
facility: Revere Court of Sacramento
state: California
city: Bensalem
country: United States
facility: Holy Redeemer Health System
state: Pennsylvania
city: Gwynedd
country: United States
facility: Foulkeways at Gwynedd
state: Pennsylvania
city: Hershey
country: United States
facility: Country Meadows Hershey
state: Pennsylvania
city: Lansdale
country: United States
facility: Meadowood Senior Living
state: Pennsylvania
city: Malvern
country: United States
facility: Camilla Hall
state: Pennsylvania
city: Newtown
country: United States
facility: Chandler Hall Health Services
state: Pennsylvania
city: Shillington
country: United States
facility: The Heritage of Green Hills
state: Pennsylvania
city: Wyomissing
country: United States
facility: Country Meadows Wyomissing
state: Pennsylvania
city: York
country: United States
facility: Country Meadows of York-South
state: Pennsylvania
Study officials:
affiliation: ActiveProtective Technologies, Inc
name: Richard Stefanacci, DO, MGH,MBA, AGSF, CMD
role: PRINCIPAL_INVESTIGATOR
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