- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04563728
Use Surveillance Technology to Reduce Elder Abuse Recidivism (MC)
Leveraging Surveillance Technology to Improve Safety in Community Aging Populations
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This a feasibility investigation that aims to conduct an 8-week pilot RCT (N=10 total) to test the potential effectiveness of a surveillance intervention to reduce frequency and severity of elder abuse among older populations. Eligible participants will be recruited from community-dwelling populations in which an older adult victim has experienced elder abuse (abuse, exploitation, neglect) according to New Jersey APS referrals or our screening. With informed written consent, participants will be evenly randomized into one of three conditions: camera, mock camera, and control (usual care).
Primary outcomes are elder abuse cases including psychological, physical, sexual abuse, financial exploitations, caregiver neglect, and self-neglect measured by 83 items. For psychological and physical abuse, we use eight items and ten items from a modified Conflict Tactics Scale (CTS).46-53. Sexual abuse will be assessed by a question asking about experiences of being touched in private areas when unwanted. Financial exploitation will be assessed by the 17-item Financial Exploitation Scale, adapted from Conrad et al in a study funded by the Department of Justice.54 Caregiver neglect will be assessed by 20 items of unmet needs in key activities of daily living among individuals living with at least one person.35,55 Self-neglect was assessed by a widely used and validated measurement56,57.The measurement was reviewed by a community advisory board of over 20 community organizations led by a geriatrician and has shown good contend, convergent58, and predictive validity59.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
New Jersey
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New Brunswick, New Jersey, United States, 08901
- Rutgers Institute for Health, Health Care Policy and Aging Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 60 or older;
- Community-living;
- Individuals identified by New Jersey APS as potentially at risk of elder abuse; OR Individuals who have experienced abuse, exploitation, or neglect within the last 3 months (assessed by any "present" or "yes" response to elder abuse questions on the screener).
Exclusion Criteria:
- Live in institutional and/or residential facilities;
- Have plans to move for the next 3 months;
- Unable to understand and provide written consent. Capacity to consent will be determined by a score of at least 24 on the Mini-mental state examination;
- Have impairment in eating, dressing, bathing, walking, transferring, grooming, bladder control, or toileting. These will be determined by any "present" or "positive" item on the Activities of Daily Living (ADLs).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Camera Group
1) The camera(s) will be a stationary device installed by the study technician on the ceiling of a common living area of the participant's home.
The camera(s) will record video and audio data to be stored in our secure data base.
The cameras will be purchased from YI Technology (see more details in Section 1.7).
A sign will be placed outside the home to notify individuals regarding the potential recording, reading, "NOTICE Audio and/or video surveillance may be in use on these premises".
Highlighted video and audio data will be reviewed daily by the study technician.
If there is evidence of abuse, exploitation, and neglect on these video and audio data, a report will be made to APS and the IRB.
|
the mock camera intervention is for testing whether the impression of surveillance would have the effect to reduce the recidivism of elder abuse in home settings; 2) whether less costly options (mock cameras) are as effective as surveillance camera(s) in reducing the recidivism of elder abuse; 3) feasibility and acceptability of surveillance camera(s)
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Active Comparator: Mock Camera Group
2) The mock camera(s) will be a stationary device installed on the ceiling of a common living area of the participant's home.
They will not record video or audio but will be installed with a sensor chip and a Wi-Fi connection, which will notify the study team if the device has been touched, tampered, altered, or disrupted power sources.
After installing the device, the study technician and study coordinator will test the anti-tampering sensor to ensure potential future tampering will be detected.
A sign will be placed outside the home to notify individuals regarding the potential recording, reading, "NOTICE Audio and/or video surveillance may be in use on these premises".
Daily check-ins to assess whether elder abuse may have been experienced by the participant will occur by phone or other preferred mode of communication.
In the event of reported abuse, exploitation, and neglect, despite not being mandatory reporters, we will report to NJ APS and the IRB.
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the mock camera intervention is for testing whether the impression of surveillance would have the effect to reduce the recidivism of elder abuse in home settings; 2) whether less costly options (mock cameras) are as effective as surveillance camera(s) in reducing the recidivism of elder abuse; 3) feasibility and acceptability of surveillance camera(s)
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No Intervention: Usual Care
Each participant will receive educational packages about elderly community-living.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
elder abuse prevalence
Time Frame: Baseline
|
Psychological, physical, sexual abuse, financial exploitation, caregiver neglect, and self-neglect. For psychological and physical abuse, we will use 8 items and 10 items from a modified Conflict Tactics Scale (CTS). Sexual abuse will be assessed by a question asking about experiences of being touched in private areas when unwanted. Financial exploitation will be assessed by the 17-item Financial Exploitation Scale, adapted from Conrad et al in a study funded by the Department of Justice. Caregiver neglect will be assessed by 20 items of unmet needs in key activities of daily living. Self-neglect will be assessed by a validated 25-item measurement. Items will be combined to report whether any vs no abuse/neglect/exploitation was experienced. In addition, multiple definitions of severity can be determined by combining these instruments and using various cut off points to determine severity. |
Baseline
|
|
elder abuse incidence
Time Frame: First week of participation
|
Psychological, physical, sexual abuse, financial exploitation, caregiver neglect, and self-neglect. For psychological and physical abuse, we will use 8 items and 10 items from a modified Conflict Tactics Scale (CTS). Sexual abuse will be assessed by a question asking about experiences of being touched in private areas when unwanted. Financial exploitation will be assessed by the 17-item Financial Exploitation Scale, adapted from Conrad et al in a study funded by the Department of Justice. Caregiver neglect will be assessed by 20 items of unmet needs in key activities of daily living. Self-neglect will be assessed by a validated 25-item measurement. Items will be combined to report whether any vs no abuse/neglect/exploitation was experienced. In addition, multiple definitions of severity can be determined by combining these instruments and using various cut off points to determine severity. |
First week of participation
|
|
elder abuse incidence
Time Frame: Second week of participation
|
Psychological, physical, sexual abuse, financial exploitation, caregiver neglect, and self-neglect. For psychological and physical abuse, we will use 8 items and 10 items from a modified Conflict Tactics Scale (CTS). Sexual abuse will be assessed by a question asking about experiences of being touched in private areas when unwanted. Financial exploitation will be assessed by the 17-item Financial Exploitation Scale, adapted from Conrad et al in a study funded by the Department of Justice. Caregiver neglect will be assessed by 20 items of unmet needs in key activities of daily living. Self-neglect will be assessed by a validated 25-item measurement. Items will be combined to report whether any vs no abuse/neglect/exploitation was experienced. In addition, multiple definitions of severity can be determined by combining these instruments and using various cut off points to determine severity. |
Second week of participation
|
|
elder abuse incidence
Time Frame: Third week of participation
|
Psychological, physical, sexual abuse, financial exploitation, caregiver neglect, and self-neglect. For psychological and physical abuse, we will use 8 items and 10 items from a modified Conflict Tactics Scale (CTS). Sexual abuse will be assessed by a question asking about experiences of being touched in private areas when unwanted. Financial exploitation will be assessed by the 17-item Financial Exploitation Scale, adapted from Conrad et al in a study funded by the Department of Justice. Caregiver neglect will be assessed by 20 items of unmet needs in key activities of daily living. Self-neglect will be assessed by a validated 25-item measurement. Items will be combined to report whether any vs no abuse/neglect/exploitation was experienced. In addition, multiple definitions of severity can be determined by combining these instruments and using various cut off points to determine severity. |
Third week of participation
|
|
elder abuse incidence
Time Frame: Fourth week of participation
|
Psychological, physical, sexual abuse, financial exploitation, caregiver neglect, and self-neglect. For psychological and physical abuse, we will use 8 items and 10 items from a modified Conflict Tactics Scale (CTS). Sexual abuse will be assessed by a question asking about experiences of being touched in private areas when unwanted. Financial exploitation will be assessed by the 17-item Financial Exploitation Scale, adapted from Conrad et al in a study funded by the Department of Justice. Caregiver neglect will be assessed by 20 items of unmet needs in key activities of daily living. Self-neglect will be assessed by a validated 25-item measurement. Items will be combined to report whether any vs no abuse/neglect/exploitation was experienced. In addition, multiple definitions of severity can be determined by combining these instruments and using various cut off points to determine severity. |
Fourth week of participation
|
|
elder abuse incidence
Time Frame: Fifth week of participation
|
Psychological, physical, sexual abuse, financial exploitation, caregiver neglect, and self-neglect. For psychological and physical abuse, we will use 8 items and 10 items from a modified Conflict Tactics Scale (CTS). Sexual abuse will be assessed by a question asking about experiences of being touched in private areas when unwanted. Financial exploitation will be assessed by the 17-item Financial Exploitation Scale, adapted from Conrad et al in a study funded by the Department of Justice. Caregiver neglect will be assessed by 20 items of unmet needs in key activities of daily living. Self-neglect will be assessed by a validated 25-item measurement. Items will be combined to report whether any vs no abuse/neglect/exploitation was experienced. In addition, multiple definitions of severity can be determined by combining these instruments and using various cut off points to determine severity. |
Fifth week of participation
|
|
elder abuse incidence
Time Frame: Sixth week of participation
|
Psychological, physical, sexual abuse, financial exploitation, caregiver neglect, and self-neglect. For psychological and physical abuse, we will use 8 items and 10 items from a modified Conflict Tactics Scale (CTS). Sexual abuse will be assessed by a question asking about experiences of being touched in private areas when unwanted. Financial exploitation will be assessed by the 17-item Financial Exploitation Scale, adapted from Conrad et al in a study funded by the Department of Justice. Caregiver neglect will be assessed by 20 items of unmet needs in key activities of daily living. Self-neglect will be assessed by a validated 25-item measurement. Items will be combined to report whether any vs no abuse/neglect/exploitation was experienced. In addition, multiple definitions of severity can be determined by combining these instruments and using various cut off points to determine severity. |
Sixth week of participation
|
|
elder abuse incidence
Time Frame: Seventh week of participation
|
Psychological, physical, sexual abuse, financial exploitation, caregiver neglect, and self-neglect. For psychological and physical abuse, we will use 8 items and 10 items from a modified Conflict Tactics Scale (CTS). Sexual abuse will be assessed by a question asking about experiences of being touched in private areas when unwanted. Financial exploitation will be assessed by the 17-item Financial Exploitation Scale, adapted from Conrad et al in a study funded by the Department of Justice. Caregiver neglect will be assessed by 20 items of unmet needs in key activities of daily living. Self-neglect will be assessed by a validated 25-item measurement. Items will be combined to report whether any vs no abuse/neglect/exploitation was experienced. In addition, multiple definitions of severity can be determined by combining these instruments and using various cut off points to determine severity. |
Seventh week of participation
|
|
elder abuse incidence
Time Frame: Eighth week of participation
|
Psychological, physical, sexual abuse, financial exploitation, caregiver neglect, and self-neglect. For psychological and physical abuse, we will use 8 items and 10 items from a modified Conflict Tactics Scale (CTS). Sexual abuse will be assessed by a question asking about experiences of being touched in private areas when unwanted. Financial exploitation will be assessed by the 17-item Financial Exploitation Scale, adapted from Conrad et al in a study funded by the Department of Justice. Caregiver neglect will be assessed by 20 items of unmet needs in key activities of daily living. Self-neglect will be assessed by a validated 25-item measurement. Items will be combined to report whether any vs no abuse/neglect/exploitation was experienced. In addition, multiple definitions of severity can be determined by combining these instruments and using various cut off points to determine severity. |
Eighth week of participation
|
|
elder abuse incidence
Time Frame: Tenth week since baseline
|
Psychological, physical, sexual abuse, financial exploitation, caregiver neglect, and self-neglect. For psychological and physical abuse, we will use 8 items and 10 items from a modified Conflict Tactics Scale (CTS). Sexual abuse will be assessed by a question asking about experiences of being touched in private areas when unwanted. Financial exploitation will be assessed by the 17-item Financial Exploitation Scale, adapted from Conrad et al in a study funded by the Department of Justice. Caregiver neglect will be assessed by 20 items of unmet needs in key activities of daily living. Self-neglect will be assessed by a validated 25-item measurement. Items will be combined to report whether any vs no abuse/neglect/exploitation was experienced. In addition, multiple definitions of severity can be determined by combining these instruments and using various cut off points to determine severity. |
Tenth week since baseline
|
|
elder abuse incidence
Time Frame: Third month since baseline
|
Psychological, physical, sexual abuse, financial exploitation, caregiver neglect, and self-neglect. For psychological and physical abuse, we will use 8 items and 10 items from a modified Conflict Tactics Scale (CTS). Sexual abuse will be assessed by a question asking about experiences of being touched in private areas when unwanted. Financial exploitation will be assessed by the 17-item Financial Exploitation Scale, adapted from Conrad et al in a study funded by the Department of Justice. Caregiver neglect will be assessed by 20 items of unmet needs in key activities of daily living. Self-neglect will be assessed by a validated 25-item measurement. Items will be combined to report whether any vs no abuse/neglect/exploitation was experienced. In addition, multiple definitions of severity can be determined by combining these instruments and using various cut off points to determine severity. |
Third month since baseline
|
|
elder abuse incidence
Time Frame: Fourth month since baseline
|
Psychological, physical, sexual abuse, financial exploitation, caregiver neglect, and self-neglect. For psychological and physical abuse, we will use 8 items and 10 items from a modified Conflict Tactics Scale (CTS). Sexual abuse will be assessed by a question asking about experiences of being touched in private areas when unwanted. Financial exploitation will be assessed by the 17-item Financial Exploitation Scale, adapted from Conrad et al in a study funded by the Department of Justice. Caregiver neglect will be assessed by 20 items of unmet needs in key activities of daily living. Self-neglect will be assessed by a validated 25-item measurement. Items will be combined to report whether any vs no abuse/neglect/exploitation was experienced. In addition, multiple definitions of severity can be determined by combining these instruments and using various cut off points to determine severity. |
Fourth month since baseline
|
|
elder abuse incidence
Time Frame: Fifth month since baseline
|
Psychological, physical, sexual abuse, financial exploitation, caregiver neglect, and self-neglect. For psychological and physical abuse, we will use 8 items and 10 items from a modified Conflict Tactics Scale (CTS). Sexual abuse will be assessed by a question asking about experiences of being touched in private areas when unwanted. Financial exploitation will be assessed by the 17-item Financial Exploitation Scale, adapted from Conrad et al in a study funded by the Department of Justice. Caregiver neglect will be assessed by 20 items of unmet needs in key activities of daily living. Self-neglect will be assessed by a validated 25-item measurement. Items will be combined to report whether any vs no abuse/neglect/exploitation was experienced. In addition, multiple definitions of severity can be determined by combining these instruments and using various cut off points to determine severity. |
Fifth month since baseline
|
|
elder abuse incidence
Time Frame: Sixth month since baseline
|
Psychological, physical, sexual abuse, financial exploitation, caregiver neglect, and self-neglect. For psychological and physical abuse, we will use 8 items and 10 items from a modified Conflict Tactics Scale (CTS). Sexual abuse will be assessed by a question asking about experiences of being touched in private areas when unwanted. Financial exploitation will be assessed by the 17-item Financial Exploitation Scale, adapted from Conrad et al in a study funded by the Department of Justice. Caregiver neglect will be assessed by 20 items of unmet needs in key activities of daily living. Self-neglect will be assessed by a validated 25-item measurement. Items will be combined to report whether any vs no abuse/neglect/exploitation was experienced. In addition, multiple definitions of severity can be determined by combining these instruments and using various cut off points to determine severity. |
Sixth month since baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Pro2019001409
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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