NCT05224843

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2021

Shorter than P25 for phase_1

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

Study Start

First participant enrolled

December 17, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 25, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 4, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2022

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 17, 2023

Completed
Last Updated

July 17, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

January 25, 2022

Results QC Date

June 14, 2023

Last Update Submit

July 11, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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 (5)

  • 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.

  • +2 more other outcomes

Study Arms (1)

Older adults in Primary Care setting

EXPERIMENTAL

Elder mistreatment in the Primary Care 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) screening tool.

Older adults in Primary Care setting

Eligibility Criteria

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

You may qualify if:

  • 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

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
  • COVID-19 positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Internal Medicine Associates

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 primary care setting.

Results Point of Contact

Title
Fuad Abujarad
Organization
Yale University

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
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: VOICES Elder Abuse Intervention
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2022

First Posted

February 4, 2022

Study Start

December 17, 2021

Primary Completion

June 22, 2022

Study Completion

June 22, 2022

Last Updated

July 17, 2023

Results First Posted

July 17, 2023

Record last verified: 2023-07

Locations