Ignite Creation Date:
2024-07-17 @ 11:02 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06467214
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-14
Brief Title:
Increasing Veterans Social Engagement and Connectedness
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Increasing Veterans Social Engagement and Connectedness
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONNECTED
Brief Summary:
Social isolation is a negative social determinant of health that affects 1-in-5 adults in the US and 43 of Veterans Social isolation is estimated to cost the nation 67 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 ie connecting Veterans to social resources Findings from this study will contribute to the VAs 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 US and contributes to 67 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 eg goal setting supportive therapy and group-based social engagement activities and 3 navigation ie 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 raciallyethnically 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 N264 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 n20 and providers experiences N10 with the intervention using semi-structured interviews to identify barriers and facilitators to the Increasing Veterans Social Engagement and Connectedness CONNECTED interventions future implementation The investigators will also survey peers and peer supervisors n20 from VISN10 VA facilities n13 and interview a subgroup of survey completers n8 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 inductivedeductive 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 interventions core elements and its implementation in diverse Veterans Health Administration facilities
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 eg goal setting supportive therapy and group-based social engagement activities and 3 navigation ie 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 raciallyethnically 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 N264 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 n20 and providers experiences N10 with the intervention using semi-structured interviews to identify barriers and facilitators to the Increasing Veterans Social Engagement and Connectedness CONNECTED interventions future implementation The investigators will also survey peers and peer supervisors n20 from VISN10 VA facilities n13 and interview a subgroup of survey completers n8 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 inductivedeductive 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 interventions core elements and its implementation in diverse Veterans Health Administration facilities
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None