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Recruiting NCT06467214

NCT06467214 Increasing Veterans' Social Engagement and Connectedness

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Clinical Trial Summary
NCT ID NCT06467214
Status Recruiting
Phase
Sponsor VA Office of Research and Development
Condition Social Isolation
Study Type INTERVENTIONAL
Enrollment 264 participants
Start Date 2024-10-04
Primary Completion 2028-06-30

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
CONNECTEDVET BEFRIENDING

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 264 participants in total. It began in 2024-10-04 with a primary completion date of 2028-06-30.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

Social isolation is a negative social determinant of health that affects 1-in-5 adults in the U.S. and 43% of Veterans. Social isolation is estimated to cost the nation $6.7 billion annually in federal healthcare spending. Yet, social isolation has rarely been the direct focus of healthcare interventions. The proposed project is a randomized controlled trial that seeks to test the effectiveness of the Increasing Veterans' Social Engagement and Connectedness (CONNECTED) intervention on social isolation among diverse Veteran groups in primary care clinics. Increasing Veterans' Social Engagement and Connectedness involves three key services delivered by peers via telehealth through individual and group sessions over 8 weeks: 1) peer support, which includes person-centered assessment for social isolation, 2) psychosocial interventions to address social isolation, and 3) navigation (i.e., connecting Veterans to social resources). Findings from this study will contribute to the VA's efforts to address social determinants of health among Veterans and to provide high quality, person-centered, and equitable care to all Veterans.

Eligibility Criteria

Inclusion Criteria: Eligible participants for Aim 1 \& Aim 2 1. Must be Veterans at the Roudebush Veterans Affairs Medical Center or its Community-Based Outpatient Clinics who had a primary care encounter in the prior 6 months and 2. Veteran obtained a score 12, indicating social isolation, on the Lubben Social Isolation Scale (LSNS-6), a validated, 6-item social isolation measure, at the time of screening in Aim 1. Exclusion Criteria: For Aim 1 and Aim 2, the investigators will exclude Veterans with 1. Active suicidal ideation needing immediate mental health treatment 2. severe cognitive, hearing or speech impairment, 3. current exacerbation of severe psychiatric symptoms (e.g., active psychosis), or 4. severe illness that makes study participation not feasible.

Contact & Investigator

Central Contact

Johanne Eliacin, PhD

✉ johanne.eliacin@va.gov

📞 (317) 988-5298

Principal Investigator

Johanne Eliacin, PhD

PRINCIPAL INVESTIGATOR

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Frequently Asked Questions

Who can join the NCT06467214 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Social Isolation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06467214 currently recruiting?

Yes, NCT06467214 is actively recruiting participants. Contact the research team at johanne.eliacin@va.gov for enrollment information.

Where is the NCT06467214 trial being conducted?

This trial is being conducted at Indianapolis, United States.

Who is sponsoring the NCT06467214 clinical trial?

NCT06467214 is sponsored by VA Office of Research and Development. The principal investigator is Johanne Eliacin, PhD at Richard L. Roudebush VA Medical Center, Indianapolis, IN. The trial plans to enroll 264 participants.

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