Increasing Veterans' Social Engagement and Connectedness
CONNECTED
1 other identifier
interventional
264
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2024
CompletedFirst Posted
Study publicly available on registry
June 20, 2024
CompletedStudy Start
First participant enrolled
October 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
July 18, 2025
July 1, 2025
3.7 years
June 14, 2024
July 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lubben Social Network Scale-6
The Lubben Social Network Scale-6 is a widely used, 6-item, self-reported measure of social isolation. It measures the frequency, size, and closeness of contact from respondents' social network. The scale has been used in both young and older adult populations, in racially diverse groups and in various settings and countries. Items are scored on a 6-point Likert scale, with total scores ranging from 0 (minimum) to 30 (maximum). Scores 12 indicate social isolation. The Lubben Social Network Scale-6 has strong internal consistency ( alpha = 0.83) and item reliability. There are no subscales.
Baseline, 2, 4, 8 months
Secondary Outcomes (8)
UCLA Loneliness Scale Short Form
Baseline, 2, 4, 8 months
General Anxiety Disorder
Baseline, 2, 4, 8 months
Patient Health Questionnaire-9
Baseline, 2, 4, 8 months
Multidimensional Scale of Perceived Social Support
Baseline, 2, 4, 8 months
Social Connectedness Scale
Baseline, 2, 4, 8 months
- +3 more secondary outcomes
Study Arms (2)
CONNECTED
EXPERIMENTALCONNECTED integrates two evidence-based care models--peer support and patient navigation--and involves the delivery of three services by peers: 1) peer support, which includes person-centered assessment for drivers of social isolation; 2) group-based interventions to address Veterans' social isolation and 3) navigation, which involves connecting Veterans to social resources to facilitate social participation. CONNECTED is delivered through individual and group sessions over 8 weeks. All sessions will be delivered via videoconference. Veterans may choose to receive some peer support sessions in person when feasible, to facilitate engagement and retention.
VET BEFRIENDING
ACTIVE COMPARATORVET BEFRIENDING (attention control arm) consists of weekly social interactions with a research assistant (RA). It will match the number of social contacts (12 contacts), frequency (weekly), intervention expectancy (positive treatment expectations), and working alliance (rapport with interventionist) in the intervention arm. The control condition has no overlap with CONNECTED in terms of content and therapeutic elements (e.g., goal setting, navigation).
Interventions
CONNECTED is a manualized, peer-led, group-based social isolation intervention for diverse veteran populations in VA primary care settings. It is delivered via videoconference through individual and group sessions over 8 weeks.
VET BEFRIENDING (attention control arm) consists of weekly social interactions with a research assistant (RA) over videoconference or phone.
Eligibility Criteria
You may qualify if:
- Eligible participants for Aim 1 \& Aim 2
- 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
- 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.
You may not qualify if:
- For Aim 1 and Aim 2, the investigators will exclude Veterans with
- Active suicidal ideation needing immediate mental health treatment
- severe cognitive, hearing or speech impairment,
- current exacerbation of severe psychiatric symptoms (e.g., active psychosis), or
- severe illness that makes study participation not feasible.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, 46202-2884, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Johanne Eliacin, PhD
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2024
First Posted
June 20, 2024
Study Start
October 4, 2024
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
June 30, 2028
Last Updated
July 18, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- The data will become available once the study team completes all analyses.
- Access Criteria
- Final research datasets underlying all publications reporting results of Veterans Administration research can be made available, upon Freedom of Information Act request.
Publications resulting from the research will be made available to the public through the National Library of Medicine PubMed Central website within one year after the date of publication. Final data sets underlying publications resulting from the research will not be shared outside Veterans Administration, except as required under the Freedom of Information Act. If final data sets under Freedom of Information Act will be shared outside Veterans Administration in electronic format. Final data sets underlying publications resulting from such research will be shared upon request. Final data sets, along with raw data and working data, will be maintained locally on a secure Veterans Administration research network drive behind the Veterans Administration firewall. Data sets based on information obtained from human subjects will be shared as a De-identified, Anonymized Dataset.