Elder AbusePhase 1VOICES-PCNCT05224843

Feasibility of VOICES Elder Abuse Intervention in Primary Care Setting (VOICES-PC Feasibility)

A 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 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. 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: 80 participants
Where: 1 siteUnited States
Study dates: 17 Dec 2021to 22 Jun 2022
Phase: 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
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

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
COVID-19 positive

Trial locations and contacts

1 site in 1 country.

United States1 site

Yale Internal Medicine Associates
New Haven, Connecticut, 06511

Other trials in United States

About this study

Official title: The Feasibility of the VOICES Digital Health Tool for Elder Mistreatment Screening in the Primary Care Setting (VOICES-PC Feasibility)

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.

Read the detailed 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

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 NCT05224843
Study group	Role	What they receive
Older adults in Primary Care setting	Experimental	Elder mistreatment in the Primary Care 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.

Participation
Participation will be determined by the number of patients enrolled in VOICES. Successful enrollment of 80 older adults (N=80).
Measured: 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).
Measured: 5-10 minutes directly following VOICES intervention.

Timeline

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

17 Dec 202122 Jun 2022

First posted4 Feb 2022
Study start17 Dec 2021
Primary completion22 Jun 2022
Study completion22 Jun 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.
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: Phase 1
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Model description: VOICES Elder Abuse Intervention
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05224843
Sponsor's protocol ID: 2000023799_b
Other IDs: 1R01AG060084-01
Acronym: VOICES-PC
Status last verified: Jul 2023
First submitted: 25 Jan 2022
Last updated: 17 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

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 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Feasibility of the VOICES Digital Health Tool for Elder Mistreatment Screening in the Primary Care Setting (VOICES-PC Feasibility)
ClinicalTrials.gov ID: NCT05224843
Acronym / sponsor ID: VOICES-PC / 2000023799_b
Conditions: Elder Abuse
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: 17 Dec 2021 (actual)
Primary completion: 22 Jun 2022 (actual)
Study completion: 22 Jun 2022 (actual)
First posted: 4 Feb 2022 (actual)
Results: Posted 17 Jul 2023

Clinical summary

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

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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: VOICES Elder Abuse Intervention

Arm	Type	Receives
Older adults in Primary Care setting	Experimental	Behavioral: Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES)Elder mistreatment in the Primary Care setting.

Who may qualify

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

Key inclusion criteria (5 listed)

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

Key exclusion criteria (6 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	Older adults in Primary Care setting

Primary outcome

Participation
Time frame: 5-10 minutes before VOICES intervention use.
Participation will be determined by the number of patients enrolled in VOICES. Successful enrollment of 80 older adults (N=80).
Usage
Time frame: 5-10 minutes directly following VOICES intervention.
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).

Results and safety

Results posted to the registry on 17 Jul 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
Older Adults Enrolled in the Study	80	80

Primary outcome: Participation

Time frame: 5-10 minutes before VOICES intervention use.. Count of participants. Unit: Participants

Measure	Older Adults Approached for the Study n = 97
Value	80

Older Adults Approached for the Study: Percentage of enrolled from eligible: 82.5 (95% CI 73.7 to 88.8)

Primary outcome: Usage

Time frame: 5-10 minutes directly following VOICES intervention.. Count of participants. Unit: Participants

Measure	Older Adults Enrolled in the Study n = 80
Value	80

Older Adults Enrolled in the Study: Percentage of enrolled from eligible: 100 (95% CI 95.4 to 100)

Adverse events

Time frame: Adverse event data for each participant was collected immediately upon occurrence during their study session (approximately 5-15 minutes including post-survey activities). Overall data were collected over the entire enrollment period, from 12/15/2022 to 6/22/2022, a period of 7 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Older Adults in Primary Care Setting	0 of 80 (0%)	0 of 80 (0%)	0 of 80

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 staff were not included in the study and outcomes only extend to older adult patients in the primary care setting.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Elder Abuse

Recruiting
Technology-Based Intervention Pilot Testing
Dementia, Elder Abuse
Not yet recruiting
Knowledge and Interpersonal Skills to Develop Enhanced Relationships (KINDER)
Elder Mistreatment, 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 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 5 inclusion and 6 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 17 Jul 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 17 Jul 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?

Participation (time frame: 5-10 minutes before VOICES intervention use.). 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 NCT05224843.

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 17 Jul 2023.