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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05224843
Other study ID # 2000023799_b
Secondary ID 1R01AG060084-01
Status Completed
Phase Phase 1
First received
Last updated
Start date December 17, 2021
Est. completion date June 22, 2022

Study information

Verified date July 2023
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To test an interactive intervention to screen for Elder Abuse and Mistreatment (EM) in the Primary Care (PC) setting to promote self-identification and self-disclosure of EM.


Description:

The aim of this study is to perform a feasibility evaluation (N=80) of the VOICES screening tool among older adults in the primary care setting. If VOICES is feasible for identifying suspicion of EM in primary care setting, then it will be able to connect more victims of EM to necessary services and potentially prevent a multitude of poor EM outcomes


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date June 22, 2022
Est. primary completion date June 22, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - Age 60 years or older - Alert and oriented to person and place - Abbreviated Mental Test (AMT-4) score of 4 - Able to consent and communicate in English - Agrees and able to use the iPad Exclusion Criteria: - subjects who live in nursing homes or other long-term care sitting and do not reside in community setting - patients will be excluded if they cannot safely undergo the studies required for participation - subjects with clear signs of EM - Patient or clinician refusal to participate - severe hearing and vision impairment - COVID-19 positive

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES)
Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES) screening tool.

Locations

Country Name City State
United States Yale Internal Medicine Associates New Haven Connecticut

Sponsors (2)

Lead Sponsor Collaborator
Yale University National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Acceptability Participant satisfaction will be measured using post-use satisfaction survey. Responses will be measured via two 5-point Likert scales where generally higher values represent better outcomes:
Scale 1- Satisfaction: Where 1= "Very Dissatisfied", 2= "Dissatisfied", 3= "Neutral", 4= "Satisfied", and 5= "Very Satisfied".
Scale 2- Agreement: Where 1= "Strongly Disagree", 2= "Disagree", 3= "Neutral", 4= "Agree", and and 5= "Strongly Agree".
5-10 minutes directly following VOICES intervention use.
Other Demand Demand will be assess through examining how likely will VOICES be used by patients. To do this, the size of target population of elder mistreatment (EM) victims in the Primary Care setting will be measured by the percent who screen positive for EM and the percent who receive the Brief Negotiation Interview (BNI) portion of VOICES. The BNI is a method designed to enhance identifying EM among older adults-- the process intends to encourage reflection of the user with their behaviors and whether they are willing to seek change by identifying with and reporting their abuse. 5-10 minutes directly following VOICES intervention use.
Other Practicality Practicality will be assessed by observing the ease of VOICES use by patients. To do this, a series of steps will be watched to determine the efficiency of implementation measured by the average time (1) to consent & orient participants to the tool and (2) needed to complete VOICES documented by the Research Assistant; and (3) patients perceived time of VOICES as measured on post-survey. Each of these will be reported as part of the overall outcome. Actual time duration is assessed during VOICES use by the computer program (the actual duration of the patient's time using VOICES). Estimation of completed time is completed 5-10 minutes directly following VOICES intervention use.
Other Efficacy of the Brief Negotiation Interview To look at how many patients changed their readiness to disclose after completing the Brief Negotiation Interview (BNI) Measure collected 5-10 minutes directly following VOICES intervention.
Other Accuracy To understand the accuracy of the VOICES tool, a preliminary evaluation of the accuracy of VOICES as a screening tool in correctly classifying elder mistreatment (EM) cases that were referred to Adult Protective Services (APS). The percent correct classification will be reported. Measure collected up to directly following VOICES intervention to 1 week following VOICES intervention.
Primary Participation Participation will be determined by the number of patients enrolled in VOICES. Successful enrollment of 80 older adults (N=80). 5-10 minutes before VOICES intervention use.
Primary Usage Usage will be determined by the number of patients enrolled in the study that complete the VOICES tool. Our target is to enroll 80 older adults (N=80). 5-10 minutes directly following VOICES intervention.
See also
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Completed NCT03834870 - Virtual cOaching in Making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES) Early Phase 1
Completed NCT04258579 - Trial to Test Effectiveness of Depression Intervention for Mistreated Older Adults N/A
Completed NCT05216081 - Feasibility of Elder Mistreatment VOICES-CI Screening Tool N/A
Terminated NCT03593564 - Knowledge and Interpersonal Skills to Develop Exemplary Relationships N/A
Not yet recruiting NCT05958654 - DETECT-RPC Universal EM Screening N/A
Recruiting NCT05807568 - MIStreatment Screening in Elders Before Discharge N/A