Virtual cOaching in Making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES)

NCT03834870 | Completed Early Phase 1 Results

• 2 other identifiers: 20000237995R01AG060084-04
• Study Type: interventional
• Target: 1,012
• Locations: 1 country
• Sites: 1

Brief Summary

To develop an interactive tool to screen for Elder Mistreatment (EM) in the Emergency Department (ED) to promote self-disclosure.

Conditions

Elder Abuse

Outcome Measures

Primary Outcomes (2)

• Implementation in Terms of Participation

  Participation will be determined by the ratio of participants who are successfully enrolled to the total number of eligible patients. The numerator, denominator, frequencies and 95% confidence intervals will be reported.

  up to 16 months

• Implementation in Terms of Usage

  Usage will be determined by the number of consented participants enrolled in the study who used VOICES to completion.

  up to 16 months

Other Outcomes (7)

• Acceptability

  up to 16 months

• Demand

  up to 16 months

• Practicality

  up to 16 months

Study Arms (1)

Elder adults in emergency department setting

EXPERIMENTAL

Elder mistreatment in an Emergency Department setting.

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

Interventions

Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES) BEHAVIORAL

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

Elder adults in emergency department setting

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 60 years or older
• Non-full trauma track
• Alert and oriented to person and place
• AMT-4 score of 4
• Able to consent and communicate in English
• Agrees and able to use the iPad
• Not in police custody

You may not qualify if:

• 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
• presenting with active psychotic symptoms
• presenting with acute intoxication
• COVID-19 positive

Sponsors & Collaborators

• Yale University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

St. Raphael Emergency Department

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Interventions

Voice

Intervention Hierarchy (Ancestors)

Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Limitations and Caveats

This study was limited to English-speaking older adults, leading to less representation with the Hispanic/Latino population. Providers, nurses and other clinical emergency department staff were not included in the study and outcomes only extend to older adult patients in the emergency department.

Results Point of Contact

• Title: Fuad Abujarad
• Organization: Yale University

fuad.abujarad@yale.edu

+1 (203) 737-5088

Study Officials

• Fuad Abujarad, PhD,MSc

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: February 8, 2019
• Study Start: July 20, 2020
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2022
• Last Updated: April 20, 2023
• Results First Posted: April 20, 2023

Record last verified: 2023-03

Locations

US (1)