Clinical trial NCT06467214: Increasing Veterans' Social Engagement and Connectedness
Official title: Increasing Veterans' Social Engagement and Connectedness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Social Isolation
Keywords: Veterans
Peer specialists
Loneliness
Navigation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2024-06-20
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a two-arm, parallel, randomized controlled trial that will enroll 264 Veterans. It will compare the Increasing Veterans' Social Engagement and Connectedness (CONNECTED, intervention arm) to an attention control group (control arm).
Primary purpose: TREATMENT

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.

Detailed description: Background: Social isolation is a global public health threat and a negative social determinant of health that affects 1 in 5 adults in the U.S. and contributes to $6.7 billion in annual healthcare spending.

Significance: Affecting roughly 43% of Veterans, social isolation is highly prevalent among Veterans, particularly those with a history of mental illness. Social isolation contributes to cardiovascular diseases, dementia, depression, suicidal ideation, and premature death. To date, social isolation remains largely unaddressed as a negative social determinant of health in healthcare systems. Current efforts to address social isolation are limited by lack of diverse participant samples, rigorous methodologies, and involvement of healthcare systems to systematically assess and reduce social isolation.

Innovation and Impact: To address these gaps, the proposed project will test a novel and feasible program to intervene on social isolation among diverse Veteran populations in the Veterans Health Administration healthcare system. The investigators propose to test the effects of the Increasing Veterans' Social Engagement and Connectedness (CONNECTED) intervention on social isolation among Veterans. The Increasing Veterans' Social Engagement and Connectedness (CONNECTED) intervention uses an innovative approach by integrating two existing evidence-based care models: peer services and patient navigation to address social isolation among Veterans in Veterans Health Administration primary care clinics. Increasing Veterans' Social Engagement and Connectedness (CONNECTED) intervention involves three key services delivered by peer specialists via telehealth over 8 weeks: 1) peer support, which includes person-centered assessment of factors driving social isolation; 2) psychosocial interventions to address Veterans' social isolation (e.g., goal setting, supportive therapy, and group-based social engagement activities); and 3) navigation (i.e., connecting Veterans to social resources in the community and the Veterans Health Administration) to help expand their social networks. Because prior social isolation studies have not prioritized inclusion of younger and racially/ethnically diverse samples, the investigators will over sample these groups using stratified random sampling.

Specific Aims: The investigators aim for a randomized controlled clinical trial comparing Increasing Veterans' Social Engagement and Connectedness (CONNECTED) intervention to an attention control group. Aim1: Test the effects of Increasing Veterans' Social Engagement and Connectedness (CONNECTED) intervention on social isolation at 2-, 4-, and 8-months from baseline compared to the control group; Aim2: Test the effects of CONNECTED on secondary, health-related outcomes; and Aim 3: Conduct formative and pre-implementation evaluations to inform future implementation processes.

Methodology: Aims 1 and 2 involve delivering the intervention to (N=264) Veterans in Veterans Health Administration primary care clinics. Data from Aims 1 and 2 will be analyzed using general linear models. In Aim 3, the investigators will describe Veterans (n=20) and providers' experiences (N=10) with the intervention using semi-structured interviews to identify barriers and facilitators to the Increasing Veterans' Social Engagement and Connectedness (CONNECTED) intervention's future implementation. The investigators will also survey peers and peer supervisors (n=20) from VISN10 VA facilities (n=13) and interview a subgroup of survey completers (n=8) to evaluate factors that may affect potential adoption of the Increasing Veterans' Social Engagement and Connectedness (CONNECTED) intervention in Veterans Health Administration and to identify future implementation strategies. Qualitative data from Aim 3 will be analyzed using an inductive/deductive approach.

Next Steps \& Implementation: Should this trial be successful the investigators will work with operational partners to implement the Increasing Veterans' Social Engagement and Connectedness (CONNECTED) intervention in the Veterans Health Administration. The next step will also involve the evaluation of Increasing Veterans' Social Engagement and Connectedness (CONNECTED) intervention's core elements and its implementation in diverse Veterans Health Administration facilities.

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.

Primary outcomes:
measure: Lubben Social Network Scale-6
timeFrame: Baseline, 2, 4, 8 months
Secondary outcomes:
measure: UCLA Loneliness Scale Short Form
timeFrame: Baseline, 2, 4, 8 months
measure: General Anxiety Disorder
timeFrame: Baseline, 2, 4, 8 months
measure: Patient Health Questionnaire-9
timeFrame: Baseline, 2, 4, 8 months
measure: Multidimensional Scale of Perceived Social Support
timeFrame: Baseline, 2, 4, 8 months
measure: Social Connectedness Scale
timeFrame: Baseline, 2, 4, 8 months
measure: Columbia Suicide Severity Rating Scale Screener
timeFrame: As indicated by endorsement of suicidal ideation on Patient Health Questionnaire-9
measure: Veterans RAND-12
timeFrame: Baseline, 2, 4, 8 months
measure: Life Engagement Test
timeFrame: Baseline, 2, 4, 8 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Richard L. Roudebush VA Medical Center, Indianapolis, IN
state: Indiana
Study officials:
affiliation: Richard L. Roudebush VA Medical Center, Indianapolis, IN
name: Johanne Eliacin, PhD
role: PRINCIPAL_INVESTIGATOR
References: