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临床试验/NCT06467214
NCT06467214招募中不适用

Increasing Veterans' Social Engagement and Connectedness

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2024年10月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
264
试验地点
2
主要终点
Lubben Social Network Scale-6

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

VET BEFRIENDING

Active Comparator

VET 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).

干预措施: VET BEFRIENDING (Behavioral)

CONNECTED

Experimental

CONNECTED 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.

干预措施: CONNECTED (Behavioral)

结局指标

主要结局

Lubben Social Network Scale-6

时间窗: Baseline, 2, 4, 8 months

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.

次要结局

  • 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)
  • Columbia Suicide Severity Rating Scale Screener(As indicated by endorsement of suicidal ideation on Patient Health Questionnaire-9)
  • UCLA Loneliness Scale Short Form(Baseline, 2, 4, 8 months)
  • Social Connectedness Scale(Baseline, 2, 4, 8 months)
  • Veterans RAND-12(Baseline, 2, 4, 8 months)
  • Life Engagement Test(Baseline, 2, 4, 8 months)
  • PTSD symptoms -Life Event Checklist (PCL-5)(Baseline, 2, 4, 8 months)
  • Life Events Checklist (LEC-5)(Baseline only)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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