| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 6 months | | | | ID | Title | Description |
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| OG000 | Intervention Group | The intervention group was 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 and received Standard of Care (SOC) 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. | | OG001 | Control Group | The control group received Standard of Care (SOC) 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. Data points on falls and fall injuries were gathered via review of subject health records for their 6 month in-study time. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0001.1(0.00 to 3.39)
- OG00112.1(8.44 to 16.68)
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Regression, Logistic | | 0.004 | The null hypothesis was tested at a one-sided 0.025 level of significance using a logistic regression analysis to compare treatment groups while controlling for propensity score. | | | | | | | | | | | | | Other | For the multiple imputation, a total of 50 imputed datasets will be calculated (Graham et al.). Fully conditional specification (FCS) discriminant function method will be used to impute missing primary endpoint using the baseline covariates of age, sex, race, ethnicity, mobility level, and BIMS Score. The FCS logistic method was replaced with the FCS discriminant function method due to a quasi-separation caused by only one observed primary endpoint event in the treatment group. |
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| Secondary | Number of Hip Fractures Related to Fall | The number of subjects in the ITT group with hip fractures related to a fall event. | 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. | Posted | | Number | 95% Confidence Interval | participants | | 6 months | | | | ID | Title | Description |
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| OG000 | Intervention Group | The intervention group was 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 and received Standard of Care (SOC) 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. | | OG001 | Control Group | The control group received Standard of Care (SOC) 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. Data points on falls and fall injuries were gathered via review of subject health records for their 6 month in-study time. |
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| Secondary | Number of Emergency Department Visits Related to Fall | The number of subjects in the ITT group with emergency department visits related to fall. | 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. | Posted | | Number | 95% Confidence Interval | participants | | 6 months | | | | ID | Title | Description |
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| OG000 | Intervention Group | The intervention group was 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 and received Standard of Care (SOC) 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. | | OG001 | Control Group | The control group received Standard of Care (SOC) 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. Data points on falls and fall injuries were gathered via review of subject health records for their 6 month in-study time. |
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| Secondary | Number of Hospitalizations Due to Fall | The number of subjects in the ITT group admitted to a hospital due to fall. | 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. | Posted | | Number | 95% Confidence Interval | participants | | 6 months | | | | ID | Title | Description |
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| OG000 | Intervention Group | The intervention group was 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 and received Standard of Care (SOC) 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. | | OG001 | Control Group | The control group received Standard of Care (SOC) 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. Data points on falls and fall injuries were gathered via review of subject health records for their 6 month in-study time. |
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| 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. | The safety population includes all subjects who were assigned a Tango Belt and attempted the run-in period. | Posted | | Number | | Number of events | | 6 months | | | | ID | Title | Description |
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| OG000 | Safety Population | The Safety Population includes all intervention subjects that were offered the study device and entered into the run-in period (207) prior to full study enrollment after passing the adherence metric (134). This group was 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 and received Standard of Care (SOC) 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. | |
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| Other Pre-specified | Number of Major Injuries Due to Fall | The number of major injuries that were due to a fall. | | Posted | | Number | | Major injuries due to fall | | 6 months | | | | ID | Title | Description |
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| OG000 | Intervention Group | The intervention group was 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 and received Standard of Care (SOC) 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. | | OG001 | Control Group | The control group received Standard of Care (SOC) 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. Data points on falls and fall injuries were gathered via review of subject health records for their 6 month in-study time. |
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| Other Pre-specified | Rate of Fall Occurence | The fall rate for the intervention and the control group | 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. | Posted | | Number | | Falls per 180-day duration | | 6 months | | | | ID | Title | Description |
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| OG000 | Intervention Group | The intervention group was 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 and received Standard of Care (SOC) 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. | | OG001 | Control Group | The control group received Standard of Care (SOC) 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. Data points on falls and fall injuries were gathered via review of subject health records for their 6 month in-study time. |
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| Other Pre-specified | Device Wear Adherence | Adherence to wearing of the study device in days/month | The study device was not offered to the control group and so device adherence was only measured for the intervention group. | Posted | | Mean | Standard Deviation | Tango Belt wear in Days/month | | 90 days and 180 days | | | | ID | Title | Description |
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| OG000 | Intervention Group | The intervention group was 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 and received Standard of Care (SOC) 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. |
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| Other Pre-specified | Device Wear Compliance | Compliance to wearing of the study device in hours/day average | | Posted | | Number | | hours/day in-study time | | 6 months | | | | ID | Title | Description |
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| OG000 | Intervention Group | The intervention group was 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 and received Standard of Care (SOC) 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. |
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| 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. | | Posted | | Number | | false positives per 1000 person-days | | 6 months | | | | ID | Title | Description |
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| OG000 | Safety Population | The Safety Population includes all intervention subjects that were offered the study device and entered into the run-in period (207) prior to full study enrollment after passing the adherence metric (134). This group was 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 and received Standard of Care (SOC) 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. |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | 6 months | | | | ID | Title | Description |
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| OG000 | The Adherence Population | The adherence population includes all subjects in the ITT who additionally met all study eligibility criteria, have available study data for the study endpoint and do not have a major protocol violation that effects primary effectiveness and the propensity matched historical controls. This population also excludes those subjects who were not actually wearing Tango Belt when the primary effectiveness endpoint was experienced. |
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| 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). | 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. | Posted | | Mean | Standard Deviation | FES-I Short Version Score | | 6 months | | | | ID | Title | Description |
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| OG000 | Intervention Group | The intervention group was 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 and received Standard of Care (SOC) 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. |
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