NCT Number: NCT07831759
There are over one million Veterans who identify as lesbian, gay, bisexual, (LGB) or a related identity. Older LGB Veterans face unique hurdles as they age, including stress, anxiety, heart disease, cancer, decreased ability to perform activities of daily living, delayed care, and increased likelihood of entering a nursing home. Sparse social networks and limited access to aging resources are common for LGB Veterans and contribute to adverse outcomes. The proposed study will partner with older Veterans to adapt and test a virtual structured group that promotes healthy aging, self-acceptance, and connection to health-related resources. This study aims to improve Veterans' health and well-being through increased resilience, positive healthcare engagement, and access to resources that support older Veterans' needs. There are currently no other VA programs designed to address the unmet needs of older LGB Veterans. By learning more about how to serve subgroups of Veterans more effectively, this study will also improve outcomes for all older Veterans and their care partners.
Trial opening soon.
Get Notified50 year and older
All sexes
Interventional
Not applicable
Tuscaloosa VA Medical Center, Tuscaloosa, AL, Tuscaloosa, Alabama, United States
Background: Older Veterans with lesbian, gay, bisexual and related identities are vulnerable to preventable differences in health outcomes. These stress-related outcomes can be traced to social, occupational, and economic mistreatment over the lifespan. Pride in All Who Served (PAWS) is an evidence-based practice that serves LGB Veterans of all ages and has been implemented in over 70 VAs with over 1000 Veteran participants. Though it was designed as a broad health promotion group, the absence of key content relevant to aging dampens its impact for older Veterans.
Significance to VA: There are currently no interventions or clinical trials that address the unmet needs of older LGB Veterans in VHA. This proposal aligns with VA priorities to address preventable health differences and the needs of aging Veterans.
Innovation and Impact: This study will adapt a novel and vital intervention for the growing population of older LGB Veterans. By addressing the structural factors that have contributed to health vulnerabilities for LGB Veterans it will also address the pressing needs of aging, promote resilience, and provide a means for aging LGB Veterans to engage positively in their health.
Specific Aims: 1) Aim 1 focuses on adapting PAWS with input from older LGB Veterans, experienced PAWS facilitators, and key clinical leaders and operations partners (e.g., Geriatrics and Extended Care services). We will then pilot the new intervention to assess feasibility and related outcomes ahead of a full-scale RCT in the future. Specifically, Aim 2 will assess the feasibility, fidelity, and acceptability of the intervention for Veterans, clinicians, clinical leaders, and operational partners. 3) Aim 3 evaluates Veteran-centered measures by examining the preliminary effects of the new intervention. Preliminary outcomes will include mental health, psychosocial, and healthy aging-related outcomes such as anxiety, resilience, social connection, healthcare engagement, risk of long-term care, and advance care planning.
Methodology: Interview and focus group data from clinicians, operational partners, and PAWS facilitators and past participants will be used to create the new intervention. The FRAME approach will be used to track and evaluate adaptations to the PAWS intervention to create the new intervention (i.e., Geri-Pride). For the single-arm pilot, between 48-64 Veterans who identify as LGB or a related identity and who are 50 years of age and older will be recruited to the pilot. The pilot is powered to detect change in anxiety as measured by 3-point pre-post differences in the Generalized Anxiety Disorder (GAD-7) score. During the pilot, fidelity will be assessed using a fidelity check list. Geri-Pride will be evaluated for acceptability of the intervention and feasibility for a future clinical trial via interviews with PAWS interventionists, Veteran participants, VA clinical leaders, and operational partners. For all aims, interviews and focus group content will be analyzed using rapid qualitative analysis. VA CDW and GECDAC data files will also be extracted to measure potential signals of impact on healthcare utilization and related outcomes (e.g., risk for admission to long- term care, financial hardship, and housing instability). Feasibility for a future clinical trial will also be assessed on outcomes such as recruitment, retention, measurement completion, etc.
Path to Translation/Implementation: Results of this proposal will generate a first of its kind intervention designed to meet the needs of older LGB Veterans. The new intervention will then be tested in a fully powered, randomized clinical trial in a subsequent Merit. If the results indicate promising impacts on Veteran outcomes, the investigators will partner with the Office of Geriatrics and Extended Care and related offices to further test and disseminate programs like this one across VA.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Unable to meet all inclusion criteria
A structured, health promotion intervention adapted from the VA Pride in All Who Served program that covers a different topic each week related to healthy aging, internalized stress, what matters most/goals of care, social connections and care networks, VA and community resources, and other topics that promote well-being.
Time frame: Active intervention-delivery period
The primary indicator of intervention feasibility will be retention rate, operationalized as the % of enrolled participants who complete the intervention as tracked on attendance logs (observational data). Feasible retention in this multi-session psychosocial intervention is set at >60% given anticipated intervention duration, prior trials with the parent intervention, and population comorbidities.
Time frame: Pre/Post Measures will be collected within approximately 1 month before the first session, and within 1 month of the last session. Time between pre and post measures will be approximately 4-6 months apart.
Symptoms of anxiety will be assessed using a 7-item self-report measure used frequently in clinical care settings within VHA. It will be completed by Veterans before and after the group.
Time frame: Pre/Post Measures will be collected within approximately 1 month before the first session, and within 1 month of the last session. Time between pre and post measures will be approximately 4-6 months apart.
Symptoms of depression will be assessed on a 9-item self-report measure of depression symptoms that is used frequently in clinical care settings within VHA. It will be completed by Veterans before and after the group.
Contact information is provided by the study sponsor or research team.
Michelle M Hilgeman, PhD
CONTACT
(205) 554-2000 ext. 3278
Teddy K Bishop, BS
CONTACT
(205) 554-2000 ext. 3676
VA Office of Research and Development
Fed
Geri Pride: an Adapted Intervention to Support Healthy Aging of Sexual and Gender Minority Veterans
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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