Increasing Veterans' Social Engagement and Connectedness

Social Isolation Clinical Trial

— CONNECTED  

Official title:

Increasing Veterans' Social Engagement and Connectedness

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06467214
• Other study ID #: IIR 22-144
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: July 1, 2024
• Est. completion date: June 30, 2028

Study information

• Verified date: June 2024
• Source: VA Office of Research and Development
• Contact: Johanne Eliacin, PhD
• Phone: (317) 988-5298
• Email: johanne.eliacin[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Social isolation is a negative social determinant of health (SDoH) 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. CONNECTED 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 SDoH among Veterans and to provide high quality, person-centered, and equitable care to all Veterans.

Description:

Background: Social isolation is a global public health threat and a negative social determinant of health (SDoH) 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 SDoH 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 VHA healthcare system. The investigators propose to test the effects of the Increasing Veterans' Social Engagement and Connectedness (CONNECTED) intervention on social isolation among Veterans. CONNECTED uses an innovative approach by integrating two existing evidence-based care models: peer services and patient navigation to address social isolation among Veterans in VHA primary care clinics. CONNECTED 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 VHA) 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 CONNECTED to an attention control group. Aim1: Test the effects of CONNECTED 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 VHA 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 CONNECTED'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 CONNECTED in VHA 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 CONNECTED in the VHA. The next step will also involve the evaluation of CONNECTED's core elements and its implementation in diverse VHA facilities.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 264
• Est. completion date: June 30, 2028
• Est. primary completion date: June 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Eligible participants for Aim 1 & Aim 2

1. Must be Veterans at the Roudebush VAMC or its CBOCs 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, we 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.

Related Conditions & MeSH terms

• Social Isolation

Intervention

Behavioral:
• CONNECTED
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
VET BEFRIENDING (attention control arm) consists of weekly social interactions with a research assistant (RA) over videoconference or phone.

Locations

Country	Name	City	State
United States	Richard L. Roudebush VA Medical Center, Indianapolis, IN	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lubben Social Network Scale-6	The LSNS-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 LSNS-6 has strong internal consistency ( = 0.83) and item reliability. There are no subscales.	Baseline, 2, 4, 8 months
Secondary	UCLA Loneliness Scale Short Form	The ULS-6 is a 6-item, self-reported measure, rated on a 4-point Likert Scale, ranging from 1 (never) to 4 (often). Items are summed for a total score ranging from 6 (minimum) to 24 (maximum). There is no subscale. The scale has demonstrated internal consistency. Higher scores indicate greater loneliness. The Cronbach coefficient alpha for this sample was 0.90.	Baseline, 2, 4, 8 months
Secondary	General Anxiety Disorder	GAD-7, a validated self-reported measure of anxiety. It has 7 items rated on a 4-point Likert scale, 0=not at all to 3= nearly every day. The scale has a total summed score of 0 (minimum) to 21 (maximum). It has shown reliability, internal consistency ( = 0.89), and good sensitivity. A meaningful change is indicated by 5 or more points. A total score of 1-4 indicates minimal symptoms, 5-9 mild symptoms, 10-14 moderate symptoms, and 12-21 severe symptoms.	Baseline, 2, 4, 8 months
Secondary	Patient Health Questionnaire-9	The PHQ-9 is a self-administered instrument used for screening, diagnosing, and monitoring the severity of depression. It has 9 items rated on a 4-point Likert Scale, ranging from 0=not at all to 3= nearly every day. PHQ-9-9 score is obtained by adding score for each item, for a total points ranging from 0 (minimum) to 27 (maximum). Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe, and severe depression respectively. The internal reliability of the PHQ-9 was excellent, with a Cronbach's of 0.89.	Baseline, 2, 4, 8 months
Secondary	Multidimensional Scale of Perceived Social Support	Multi-dimensional Scale of Perceived Social Support (MSPSS) scale is self-administered. It has 12-items, measured on a 7-point a Likert scale (1=very strongly disagree) to 7=(very strongly agree). Total scale score is the sum across all 12 items. It can also be calculated as a mean score (divided by 12). Summed total score ranges from 12 (minimum) to 84 (maximum). The scale has high internal consistency ( = .88). There is no established population norms on the MSPSS. There are 3 subscales.There are 3 subscales, with 4 item each. Their scores are the sum of the items divided by 4. Significant Other subscale (items 1, 2, 5, 10), Family subscale (3, 4, 8, 11), and Friends subscale (6, 7, 9, 12).	Baseline, 2, 4, 8 months
Secondary	Social Connectedness Scale	The SCS is a widely used 8-item measure that assesses aspects of belongingness, affiliation, and companionship. It is rated on a 6-point Likert scale, 1=strongly disagree to 6=strongly agree. The items are then summed for a total score, ranging from 8 (minimum) to 36 (maximum). A high score indicates more connectedness to others or reflects a greater sense of social connectedness. Internal reliability estimates for the 2 scales were .91 and .82, respectively.	Baseline, 2, 4, 8 months
Secondary	Columbia Suicide Severity Rating Scale Screener	"The Columbia Protocol, also known as the Columbia-Suicide Severity Rating Scale (C-SSRS), supports suicide risk assessment through a series of simple, plain-language questions that anyone can ask. The answers help users identify whether someone is at risk for suicide, assess the severity and immediacy of that risk, and gauge the level of support that the person needs. The C-SSRS evidenced excellent internal consistency (ordinal = .95). Users of the tool ask people: Whether and when they have thought about suicide (ideation) What actions they have taken - and when - to prepare for suicide Whether and when they attempted suicide or began a suicide attempt that was either interrupted by another person or stopped of their own volition"	As indicated by endorsement of SI on PHQ-9
Secondary	Veterans Rand-12	The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. Its Internal consistency is high( s = .87 to .96).64	Baseline, 2, 4, 8 months
Secondary	Life Engagement Test	The LET is a 6-item survey that measures the extent to which a person engages in activities that are valued ( = .80)61.	Baseline, 2, 4, 8 months