Elder AbuseEarly Phase 1VOICESNCT03834870

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

A Early Phase 1 study testing Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES) in people with Elder Abuse, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for: Elder Abuse
What is being tested?: Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,012 participants
Where: 1 siteUnited States
Study dates: 20 Jul 2020to 1 Mar 2022
Phase: Early Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

St. Raphael Emergency Department
New Haven, Connecticut, 06511

Other trials in United States

About this study

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

Read the detailed description

To develop and refine the interactive VOICES tool, which will promote self-identification and self-disclosure to increase reporting of EM at point-of-care in the Emergency Department (ED) setting. Prior to conducting a feasibility study, focus groups will be conducted to inform the process and to develop a tool to evaluate the use of VOICES.

Feasibility Study: To conduct a feasibility study (N= 800) examining the use of VOICES in a busy ED.

Exploratory Aim: To perform a preliminary evaluation of the accuracy of VOICES as a screening tool in correctly classifying EM cases that were referred to Adult Protective Services (APS).

Conditions: Elder Abuse
Being tested: Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03834870
Study group	Role	What they receive
Elder adults in emergency department setting	Experimental	Elder mistreatment in an Emergency Department setting. Receives: Behavioral: Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: up to 16 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jul 20201 Mar 2022

First posted8 Feb 2019
Study start20 Jul 2020
Primary completion1 Dec 2021
Study completion1 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Elder AbuseStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1,012 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03834870
Sponsor's protocol ID: 2000023799
Other IDs: 5R01AG060084-04
Acronym: VOICES
Status last verified: Mar 2023
First submitted: 14 Dec 2018
Last updated: 20 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Publications

Abujarad F, Edwards C, Choo E, Pantalon MV, Jubanyik K, Kaur M, Vander Wyk B, Dziura J, D'Onofrio G, Gill TM. Feasibility evaluation of using virtual coaching in making informed choices on elder mistreatment self-reporting (VOICES) tool in an emergency department. J Elder Abuse Negl. 2026 Aug 24:1-27. doi: 10.1080/08946566.2026.2722265. Online ahead of print.
PubMed 42635253

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Elder Abuse trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Virtual cOaching in Making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES)
ClinicalTrials.gov ID: NCT03834870
Acronym / sponsor ID: VOICES / 2000023799
Conditions: Elder Abuse
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,012 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: 20 Jul 2020 (actual)
Primary completion: 1 Dec 2021 (actual)
Study completion: 1 Mar 2022 (actual)
First posted: 8 Feb 2019 (actual)
Results: Posted 20 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Feasibility Study: To conduct a feasibility study (N= 800) examining the use of VOICES in a busy ED.

Exploratory Aim: To perform a preliminary evaluation of the accuracy of VOICES as a screening tool in correctly classifying EM cases that were referred to Adult Protective Services (APS).

Study design

Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Elder adults in emergency department setting	Experimental	Behavioral: Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES)Elder mistreatment in an Emergency Department setting.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Behavioural	Elder adults in emergency department setting

Primary outcome

Implementation in Terms of Participation
Time frame: up to 16 months
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.
Implementation in Terms of Usage
Time frame: up to 16 months
Usage will be determined by the number of consented participants enrolled in the study who used VOICES to completion.

Results and safety

Results posted to the registry on 20 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Elder Adults in Emergency Department Setting	1,012	1,002

Primary outcome: Implementation in Terms of Participation

Time frame: up to 16 months. Count of participants. Unit: Participants

Measure	Elder Adults in Emergency Department Setting n = 1204
Value	1012

Elder Adults in Emergency Department Setting: Percentage of enrolled from eligible: 84.05 (95% CI 81.98 to 86.10)

Population analysed: The total number of eligible participants.

Primary outcome: Implementation in Terms of Usage

Time frame: up to 16 months. Count of participants. Unit: Participants

Measure	Elder Adults in Emergency Department Setting n = 1012
Value	1002

Elder Adults in Emergency Department Setting: Percentage of enrolled from eligible: 99.01 (95% CI 98.40 to 99.60)

Population analysed: The number of participants who were enrolled in the study (n=1,012)/

Adverse events

Time frame: Up to 16 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Elder Adults in Emergency Department Setting	0 of 1,012 (0%)	0 of 1,012 (0%)	0 of 1,012

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42635253Abujarad F, Edwards C, Choo E, Pantalon MV, Jubanyik K, Kaur M, Vander Wyk B, Dziura J, D'Onofrio G, Gill TM. Feasibility evaluation of using virtual coaching in making informed choices on elder mistreatment self-reporting (VOICES) tool in an emergency department. J Elder Abuse Negl. 2026 Aug 24:1-27. doi: 10.1080/08946566.2026.2722265. Online ahead of print.

Related trials for Elder Abuse

Not yet recruiting
Knowledge and Interpersonal Skills to Develop Enhanced Relationships (KINDER)
Elder Mistreatment, Elder Abuse
Not yet recruiting
Technology-Based Intervention Pilot Testing
Dementia, Elder Abuse
Not yet recruiting
Primary Care Screening and Intervention for Patients With Dementia and Caregivers
Dementia, Elder Abuse
Recruiting
Tele-PROTECT Therapy: Effectiveness, Empowerment, and Implementation
Depression, Elder Abuse
Recruiting
Leveraging Adult Protective Service Interaction to Offer Evidence-Based Treatment for Depression in Elder Neglect/Self Neglect
Depression in Old Age

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fuad Abujarad, PhD,MSc principal investigator

Yale University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES) in people with Elder Abuse, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Implementation in Terms of Participation (time frame: up to 16 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03834870, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.