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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04563728
Other study ID # Pro2019001409
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date May 1, 2020
Est. completion date March 1, 2022

Study information

Verified date February 2024
Source Rutgers, The State University of New Jersey
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The project is to build multi-sector and multi-institutional partnerships to test the feasibility, acceptability, and efficacy of a pilot surveillance camera intervention (N=10) to reduce the frequency and severity of abuse, exploitation, and neglect in community older adults.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date March 1, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: 1. Aged 60 or older; 2. Community-living; 3. 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: 1. Live in institutional and/or residential facilities; 2. Have plans to move for the next 3 months; 3. 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; 4. 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Surveillance camera(s)
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)

Locations

Country Name City State
United States Rutgers Institute for Health, Health Care Policy and Aging Research New Brunswick New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Rutgers University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary elder abuse prevalence 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
Primary elder abuse incidence 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
Primary elder abuse incidence 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
Primary elder abuse incidence 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
Primary elder abuse incidence 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
Primary elder abuse incidence 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
Primary elder abuse incidence 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
Primary elder abuse incidence 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
Primary elder abuse incidence 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
Primary elder abuse incidence 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
Primary elder abuse incidence 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
Primary elder abuse incidence 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
Primary elder abuse incidence 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
Primary elder abuse incidence 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
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