Fall Injury, Fall Risk, Fractures, Hip, Hip Injuries, Osteoporosis, Osteoporosis Risk
Conditions
Keywords
Fall risk, Fall injury, Major hip injury, Hip fracture
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.
Interventions
DEVICETango Belt
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.
OTHERStandard of Care (SOC)
The standard of care (SOC) in the US for managing the fall risk of geriatric patients is the CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative, which implements the America and British Geriatric Societies'' Clinical Practice Guidelines for fall risk management. The STEADI algorithm consists of tools and resources for healthcare providers for fall risk screening, assessment, and interventioniv,v. Screening and assessment includes identifying fall history and modifiable factors related to fall and fall injury risk (e.g. fear of falling, gait, strength, balance, medications, comorbidities, etc.); then interventions to reduce the fall and fall injury risk are applied based upon assessment findings, and can include physical therapy, medication adjustments, patient education, bed and chair alarms, bed rails, etc.
Sponsors
Avania
ActiveProtective Technologies, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Hip Injuries Due to Serious Hip-impacting Fall | 6 months | The percent of subjects in the ITT population with major hip injuries due to serious hip-impacting falls. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Hip Fractures Related to Fall | 6 months | The number of subjects in the ITT group with hip fractures related to a fall event. |
| Number of Emergency Department Visits Related to Fall | 6 months | The number of subjects in the ITT group with emergency department visits related to fall. |
| Number of Hospitalizations Due to Fall | 6 months | The number of subjects in the ITT group admitted to a hospital due to fall. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Device Wear Compliance | 6 months | Compliance to wearing of the study device in hours/day average |
| Accuracy of Device Fall Discrimination | 6 months | Rate of airbag deployments that occurred while an intervention subject was not experiencing a serious hip-impacting fall. |
| Rate of Fall Occurence | 6 months | The fall rate for the intervention and the control group |
| Balance Confidence Score Changes | 6 months | Short version of the Falls Efficacy Scale International (where applicable for those deemed able to take the questionnaire (BIMS of 13-15)) to offer level of balance confidence as defined by the scale (range from 7 (no concern about falling) to 28 (severe concern about falling). |
| Accuracy of Study Device Airbag Deployment | 6 months | Accuracy of the study device airbag deployment as designed is demonstrated in the number of hip fractures that occurred by intervention subjects wearing the device during serious hip-impacting falls. |
| Number and Severity of Adverse Events | 6 months | An Adverse Event is any untoward medical occurrences in a patient or subject receiving an investigational medical device and does not necessarily have to have a causal relationship with the device under investigation. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical device whether or not considered related to the medical device. Any fall event is considered an AE for this study. A Severe Adverse Event is any AE that results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/ incapacity. |
| Number of Major Injuries Due to Fall | 6 months | The number of major injuries that were due to a fall. |
| Device Wear Adherence | 90 days and 180 days | Adherence to wearing of the study device in days/month |
Countries
United States
Participant flow
Recruitment details
The intervention group was recruited via clinical site health record review for the inclusion/exclusion criteria available and waist circumference obtained by sub-investigator on-site and offered informed consent. The control group was determined via historical clinical site health record review determining subject eligibility based on inclusion/exclusion criteria except waist circumference and did not need consent.
Pre-assignment details
Intervention subjects initially enrolled (207) attempted a 14-day run-in period during which adherence to use of the study device was measured. 73 subjects who do not meet the run-in period requirement (64% adherence to wear) were withdrawn from the study resulting in 134 fully enrolled intervention group subjects.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group The intervention group subjects meeting the requirements of the inclusion and exclusion criteria and who consented to study enrollment, received Standard of Care (SOC) for managing fall risk as per the CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative and were 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. | 134 |
| Control Group Control group subjects meeting the requirements of the inclusion and exclusion criteria (except for the waist circumference and need for consent) were identified via clinical site health records and received the standard of care (SOC) for managing fall risk as per the CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative. Their falls and fall injuries were recorded for the 6 months following their retrospective enrollment date. | 264 |
| Total | 398 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 13 | 2 |
| Overall Study | Death | 6 | 7 |
| Overall Study | Physician Decision | 6 | 0 |
| Overall Study | Protocol Violation | 8 | 6 |
| Overall Study | Relocation | 4 | 3 |
| Overall Study | Withdrawal by Subject | 18 | 0 |
Baseline characteristics
| Characteristic | Total | Control Group | Intervention Group |
|---|---|---|---|
| Age, Continuous | 87.5 years STANDARD_DEVIATION 6.7 | 87.5 years STANDARD_DEVIATION 6.4 | 87.3 years STANDARD_DEVIATION 7.15 |
| Fall Risk Factor | 374 Participants | 249 Participants | 125 Participants |
| Highest Mobility Level Extensive Assist | 2 Participants | 1 Participants | 1 Participants |
| Highest Mobility Level Independent | 224 Participants | 149 Participants | 75 Participants |
| Highest Mobility Level Limited Assist | 104 Participants | 70 Participants | 34 Participants |
| Highest Mobility Level Supervision | 68 Participants | 44 Participants | 24 Participants |
| Highest Mobility Level Total Dependence | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaskan Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 5 Participants | 4 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Black or African American | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Other | 5 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Race White | 386 Participants | 257 Participants | 129 Participants |
| Region of Enrollment United States | 398 participants | 264 participants | 134 participants |
| Sex: Female, Male Female | 311 Participants | 209 Participants | 102 Participants |
| Sex: Female, Male Male | 87 Participants | 55 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 207 | 7 / 264 |
| other Total, other adverse events | 67 / 207 | 152 / 264 |
| serious Total, serious adverse events | 33 / 207 | 66 / 264 |
Outcome results
Primary
Major Hip Injuries Due to Serious Hip-impacting Fall
The percent of subjects in the ITT population with major hip injuries due to serious hip-impacting falls.
Time frame: 6 months
Population: The analysis population consists of all intervention population subjects who demonstrated at least 64% adherence to use of device during run-in period and the propensity matched historical controls.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group | Major Hip Injuries Due to Serious Hip-impacting Fall | 1.1 percentage of participants |
| Control Group | Major Hip Injuries Due to Serious Hip-impacting Fall | 12.1 percentage of participants |
p-value: 0.004Regression, Logistic
Secondary
Number of Emergency Department Visits Related to Fall
The number of subjects in the ITT group with emergency department visits related to fall.
Time frame: 6 months
Population: The analysis population consisted of all intervention population subjects who demonstrate at least 64% adherence to use of device during run-in period (defined as wearing device for at least 1 hour per day for at least 9 of 14 days) and the propensity matched historical controls.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group | Number of Emergency Department Visits Related to Fall | 8 participants |
| Control Group | Number of Emergency Department Visits Related to Fall | 47 participants |
p-value: 0.001Regression, Logistic
Secondary
Number of Hip Fractures Related to Fall
The number of subjects in the ITT group with hip fractures related to a fall event.
Time frame: 6 months
Population: The analysis population consisted of all intervention population subjects who demonstrate at least 64% adherence to use of device during run-in period (defined as wearing device for at least 1 hour per day for at least 9 of 14 days) and the propensity matched historical controls.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group | Number of Hip Fractures Related to Fall | 3 participants |
| Control Group | Number of Hip Fractures Related to Fall | 30 participants |
p-value: 0.003Regression, Logistic
p-value: 0.003Regression, Logistic
Secondary
Number of Hospitalizations Due to Fall
The number of subjects in the ITT group admitted to a hospital due to fall.
Time frame: 6 months
Population: The analysis population consisted of all intervention population subjects who demonstrate at least 64% adherence to use of device during run-in period (defined as wearing device for at least 1 hour per day for at least 9 of 14 days) and the propensity matched historical controls.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group | Number of Hospitalizations Due to Fall | 11 participants |
| Control Group | Number of Hospitalizations Due to Fall | 50 participants |
p-value: 0.003Regression, Logistic
Other Pre-specified
Accuracy of Device Fall Discrimination
Rate of airbag deployments that occurred while an intervention subject was not experiencing a serious hip-impacting fall.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group | Accuracy of Device Fall Discrimination | 1.59 false positives per 1000 person-days |
Other Pre-specified
Accuracy of Study Device Airbag Deployment
Accuracy of the study device airbag deployment as designed is demonstrated in the number of hip fractures that occurred by intervention subjects wearing the device during serious hip-impacting falls.
Time frame: 6 months
Population: The adherence population includes all subjects in the PP population excluding those subjects who were not actually wearing Tango Belt when the primary effectiveness endpoint was experienced.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group | Accuracy of Study Device Airbag Deployment | 0 Participants |
Other Pre-specified
Balance Confidence Score Changes
Short version of the Falls Efficacy Scale International (where applicable for those deemed able to take the questionnaire (BIMS of 13-15)) to offer level of balance confidence as defined by the scale (range from 7 (no concern about falling) to 28 (severe concern about falling).
Time frame: 6 months
Population: The number of intervention subjects changed as the study time line proceeded and some intervention subjects exited prior to the 90 day and 180 day.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Balance Confidence Score Changes | Baseline | 15.3 FES-I Short Version Score | Standard Deviation 4.29 |
| Intervention Group | Balance Confidence Score Changes | 90 day | 15.4 FES-I Short Version Score | Standard Deviation 4.16 |
| Intervention Group | Balance Confidence Score Changes | 180 day | 14.7 FES-I Short Version Score | Standard Deviation 4.68 |
Other Pre-specified
Device Wear Adherence
Adherence to wearing of the study device in days/month
Time frame: 90 days and 180 days
Population: The study device was not offered to the control group and so device adherence was only measured for the intervention group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Device Wear Adherence | 90 day | 21.9 Tango Belt wear in Days/month | Standard Deviation 6.08 |
| Intervention Group | Device Wear Adherence | 180 day | 20.1 Tango Belt wear in Days/month | Standard Deviation 6.71 |
Other Pre-specified
Device Wear Compliance
Compliance to wearing of the study device in hours/day average
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group | Device Wear Compliance | 5.9 hours/day in-study time |
Other Pre-specified
Number and Severity of Adverse Events
An Adverse Event is any untoward medical occurrences in a patient or subject receiving an investigational medical device and does not necessarily have to have a causal relationship with the device under investigation. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical device whether or not considered related to the medical device. Any fall event is considered an AE for this study. A Severe Adverse Event is any AE that results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/ incapacity.
Time frame: 6 months
Population: The safety population includes all subjects who were assigned a Tango Belt and attempted the run-in period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention Group | Number and Severity of Adverse Events | Mild Severity Adverse event | 163 Number of events |
| Intervention Group | Number and Severity of Adverse Events | Moderate Severity Adverse Event | 29 Number of events |
| Intervention Group | Number and Severity of Adverse Events | Severe Severity Adverse Event | 27 Number of events |
| Control Group | Number and Severity of Adverse Events | Mild Severity Adverse event | 232 Number of events |
| Control Group | Number and Severity of Adverse Events | Moderate Severity Adverse Event | 70 Number of events |
| Control Group | Number and Severity of Adverse Events | Severe Severity Adverse Event | 66 Number of events |
Other Pre-specified
Number of Major Injuries Due to Fall
The number of major injuries that were due to a fall.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group | Number of Major Injuries Due to Fall | 7 Major injuries due to fall |
| Control Group | Number of Major Injuries Due to Fall | 67 Major injuries due to fall |
Other Pre-specified
Rate of Fall Occurence
The fall rate for the intervention and the control group
Time frame: 6 months
Population: The fall rate ratio was compared between treatment groups using a Poisson regression model. Treatment was the independent variable and the log of total 180-day durations was the offset variable. The p-value corresponds to the beta coefficient on the treatment variable. A two-sided 0.05 level of significance was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group | Rate of Fall Occurence | 1.56 Falls per 180-day duration |
| Control Group | Rate of Fall Occurence | 1.31 Falls per 180-day duration |