NCT05216081

Brief Summary

The aim of this study is to assess the feasibility of the VOICES Elder Abuse Intervention among older adults with cognitive impairment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 31, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 22, 2023

Completed
Last Updated

September 22, 2023

Status Verified

August 1, 2023

Enrollment Period

7 months

First QC Date

January 11, 2022

Results QC Date

August 10, 2023

Last Update Submit

August 29, 2023

Conditions

Elder AbuseElder Mistreatment

Keywords

Digital Health

Outcome Measures

Primary Outcomes (2)

  • Participation

    Participation will be determined by the number of patients with cognitive impairment enrolled in VOICES. Successful enrollment of 80 older adults (N=80).

    5-10 minutes before VOICES intervention use.

  • 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.

Other Outcomes (6)

  • Acceptability

    5-10 minutes directly following VOICES intervention use.

  • Demand

    5-10 minutes directly following VOICES intervention use.

  • Practicality

    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.

  • +3 more other outcomes

Study Arms (1)

Elder adults in emergency department setting with cognitive impairment

EXPERIMENTAL

Elder mistreatment in an Emergency Department setting with cognitive impairment.

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 with cognitive impairment

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Age 60 or above
  • Montreal Cognitive Assessment (MoCA) score between 14-25
  • Not in police custody
  • Non-full trauma track upon arrival
  • Able to consent and communicate in English
  • Agrees and able to use the iPad

You may not qualify if:

  • Subjects who live in nursing homes or other long-term care settings
  • At the discretion of the clinician, patient will be excluded if they cannot safely undergo the studies required for participation
  • Subject refusal to participate
  • Subjects with clear signs of elder mistreatment
  • Severe hearing and vision impairment
  • Presenting with acute intoxication
  • Presenting with active psychotic symptoms
  • Presenting with COVID-19 diagnosis and/or severe COVID-19 symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Raphael Emergency Department

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Interventions

Voice

Intervention Hierarchy (Ancestors)

Respiratory Physiological PhenomenaCirculatory 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 staff were not included in the study and outcomes only extend to older adult patients in the emergency department setting.

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
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2022

First Posted

January 31, 2022

Study Start

February 1, 2022

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

September 22, 2023

Results First Posted

September 22, 2023

Record last verified: 2023-08

Locations

US(1)