Evaluating Integrated Care and Wearable Technology Outcomes in the Shields & Stripes Program for Veterans and First Responders: A Retrospective Mixed-Methods Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Psychological Functioning Generalized Anxiety Disorder 7-item (GAD-7) scale
研究概览
简要总结
This study aims to evaluate outcomes from the Shields & Stripes (S&S) program - a 12-week, multidisciplinary wellness intervention designed for veterans and first responders. The S&S program integrates occupational therapy (OT), mental health (MH), physical therapy (PT), and registered dietitian (RD) services to promote recovery, resilience, and performance in individuals who have experienced cumulative stress, trauma exposure, or occupational burnout.
This research will use a retrospective mixed-methods observational design to analyze data collected from previous S&S participants who consent to research use of their de-identified information. No intervention or treatment changes will occur as part of this study.
Quantitative data will include biometric information (e.g., sleep, activity, and heart rate variability via Oura Ring), standardized self-report measures (GAD-7, PHQ-9, PCL-5, RAND-36, PSQI, ISI), satisfaction surveys, and laboratory nutrition panels. Qualitative data will include semi-structured interviews with consenting participants and S&S providers following program completion.
The purpose of the study is to identify patterns of improvement in physical, psychological, and occupational functioning and to explore how integrated, team-based care supports holistic recovery. Findings may inform the development of future evidence-based wellness programs for military and first-responder populations.
Participation involves minimal risk, and all data will be de-identified before analysis.
详细描述
Study Overview This retrospective mixed-methods observational study evaluates the effectiveness of the Shields & Stripes (S&S) program, a 12-week integrated wellness model that combines occupational therapy (OT), mental health (MH) services, physical therapy (PT), and registered dietitian (RD) support. The program serves veterans and first responders who experience cumulative physical, cognitive, and emotional stress related to their service.
The study will retrospectively analyze quantitative and qualitative data from S&S cohorts between 2024-2026 to assess changes in health, functioning, and quality of life.
Objectives
Evaluate changes in physical, psychological, and occupational functioning following participation in S&S.
Explore relationships between biometric indicators (e.g., heart-rate variability, sleep, activity) and self-reported well-being.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-70 years
- •Current or former members of the U.S. Armed Forces or first responder professions (e.g., law enforcement, firefighting, EMS)
- •Participants who completed the Shields & Stripes holistic wellness program
- •Providers who worked within the Shields and Stripes program.
排除标准
- 未提供
研究组 & 干预措施
Shields & Stripes Program Participants
Participants include veterans and first responders who have completed the 12-week Shields & Stripes holistic wellness program. The program integrates occupational therapy, mental health, physical therapy, and registered dietitian services to address physical, psychological, and occupational functioning.
Data analyzed for this study include de-identified biometric, psychological, and laboratory outcomes collected as part of standard program procedures. Past and present program providers will also serve as participants to gain a better understanding of the program and its impact. No additional interventions are introduced for research purposes.
结局指标
主要结局
Change in Psychological Functioning Generalized Anxiety Disorder 7-item (GAD-7) scale
时间窗: Baseline (Week 0) to Post-Program (Week 12)
To assess changes in anxiety symptoms before and after participation in the 12-week Shields \& Stripes program using validated self-report measures. Score range: 0 to 21 Higher scores indicate: Worse anxiety symptoms
Change in Psychological Functioning utilizing Patient Health Questionnaire-9 (PHQ-9)
时间窗: Baseline (Week 0) to Post-Program (Week 12)
To assess changes in depression symptoms before and after participation in the 12-week Shields \& Stripes program using validated self-report measures. Score range: 0 to 27 Higher scores indicate: Worse depressive symptoms
Change in Psychological Functioning utilizing the Posttraumatic Stress Disorder Checklist (PCL-5)
时间窗: Baseline (Week 0) to Post-Program (Week 12)
To assess changes in post-traumatic stress symptoms before and after participation in the 12-week Shields \& Stripes program using validated self-report measures. Score range: 0 to 80 Higher scores indicate: Worse PTSD symptoms
次要结局
- Change in Heart Rate Variability (HRV)(Pre-Program (T-4 weeks), Program Start (Week 0), and Post-Program (Week 12))
- Change in Sleep Quality - Pittsburgh Sleep Quality Index (PSQI)(Baseline (Week 0) to Post-Program (Week 12))
- Change in Health-Related Quality of Life - RAND 36-Item Health Survey (RAND-36)(Baseline (Week 0) to Post-Program (Week 12))
- Qualitative Themes from Semi-Structured Interviews(Post-Program (within 4 weeks of completion))
- Change in Physical Function and Performance (PSFS)(Baseline (Week 0) to Post-Program (Week 12))
- Change in Sleep Duration(Pre-Program (T-4 weeks), Program Start (Week 0), and Post-Program (Week 12))
- Change in Sleep Efficiency(Pre-Program (T-4 weeks), Program Start (Week 0), and Post-Program (Week 12))
- Change in Resting Heart Rate(Pre-Program (T-4 weeks), Program Start (Week 0), and Post-Program (Week 12))
- Change in Physical Activity Level(Pre-Program (T-4 weeks), Program Start (Week 0), and Post-Program (Week 12))
- Change in Insomnia Severity - Insomnia Severity Index (ISI)(Baseline (Week 0) to Post-Program (Week 12))
- Change in Total Cholesterol(Baseline (Week 0) to Post-Program (Week 12))
- Change in HDL Cholesterol(Baseline (Week 0) to Post-Program (Week 12))
- Change in LDL Cholesterol(Baseline (Week 0) to Post-Program (Week 12))
- Change in Triglycerides(Baseline (Week 0) to Post-Program (Week 12))
- Change in Fasting Glucose(Baseline (Week 0) to Post-Program (Week 12))
- Change in Hemoglobin A1c (HbA1c)(Baseline (Week 0) to Post-Program (Week 12))
- Change in High-Sensitivity C-Reactive Protein (hs-CRP)(Baseline (Week 0) to Post-Program (Week 12))
- Change in Vitamin D (25-hydroxyvitamin D)(Baseline (Week 0) to Post-Program (Week 12))
- Change in Thyroid Stimulating Hormone (TSH)(Baseline (Week 0) to Post-Program (Week 12))
研究者
Kelli Cabrera
Lecturer and Principal Investigator, Department of Occupational Therapy, Baylor University
Baylor University