Набор скоро начнётся NCT07452900

Using Integrated Care and Wearable Technology to Evaluate Outcomes of the Shields & Stripes Program for Veterans and First Responders

— Наблюдательное Holistic Care Mental Health Sleep PTSD

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Holistic Care, Mental Health, Sleep, PTSD. Базовые параметры: 18 лет — 70 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Evaluating Integrated Care and Wearable Technology Outcomes in the Shields & Stripes Program for Veterans and First Responders: A Retrospective Mixed-Methods Study

Обзор

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.

Подробное описание

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.

Examine trends in nutrition and metabolic markers across cohorts.

Analyze participant and provider perspectives through qualitative interviews to better understand mechanisms of change and perceived program value.

Design and Methods

Design: Convergent mixed-methods retrospective observational study.

Quantitative Data: Includes biometric data (sleep, HRV, activity), self-report scales (GAD-7, PHQ-9, PCL-5, RAND-36, PSQI, ISI), and laboratory measures (cholesterol, glucose regulation, vitamin D, testosterone, thyroid, inflammatory markers, etc.).

Qualitative Data: Semi-structured interviews with consenting participants and providers conducted post-program (via teleconference).

Participants: Veterans and first responders aged 18-70 who have completed the S\&S program and program providers who have worked within the S\&S program.

Recruitment: No direct external recruitment will occur for this study. All participants will be drawn from existing Shields \& Stripes program cohorts and affiliated program providers, which utilize processes separate from this research.

Data Handling: All data will be de-identified prior to analysis; stored securely on encrypted, access-restricted cloud servers.

Primary Outcomes

Change in self-reported anxiety (GAD-7)

Change in depressive symptoms (PHQ-9)

Change in PTSD symptoms (PCL-5)

Change in sleep (PSQI and ISI)

Change in quality of life (RAND-36)

Change in sleep quality and recovery metrics (Oura Ring data)

Secondary Outcomes

Changes in nutritional and metabolic lab results (e.g., cholesterol, glucose, vitamin D, thyroid function).

Qualitative themes related to perceived program benefit, barriers, and provider perspectives.

Duration and Setting Data will be collected retrospectively from cohorts between 2024-2026. The study will take place remotely with data stored and analyzed by the research team.

Risk and Safeguards The study is minimal risk. No interventions or procedures are performed beyond standard program participation. Risks are limited to potential discomfort during interviews and minimal risk of confidentiality breach, mitigated through HIPAA-compliant data handling.

Expected Impact Results will inform how multidisciplinary programs combining OT, MH, PT, and RD services improve functional, psychological, and physiological outcomes among high-stress occupational populations. The study aims to contribute to the evidence base for integrated, holistic wellness approaches for veterans and first responders.

Первичные конечные точки

Change in Psychological Functioning Generalized Anxiety Disorder 7-item (GAD-7) scale [Срок оценки: Baseline (Week 0) to Post-Program (Week 12)]
Change in Psychological Functioning utilizing Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: Baseline (Week 0) to Post-Program (Week 12)]
Change in Psychological Functioning utilizing the Posttraumatic Stress Disorder Checklist (PCL-5) [Срок оценки: Baseline (Week 0) to Post-Program (Week 12)]

Вторичные конечные точки (12)

Change in Heart Rate Variability (HRV) [Срок оценки: Pre-Program (T-4 weeks), Program Start (Week 0), and Post-Program (Week 12)]
Change in Sleep Quality - Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Baseline (Week 0) to Post-Program (Week 12)]
Change in Health-Related Quality of Life - RAND 36-Item Health Survey (RAND-36) [Срок оценки: Baseline (Week 0) to Post-Program (Week 12)]
Change in Total Cholesterol [Срок оценки: Baseline (Week 0) to Post-Program (Week 12)]
Qualitative Themes from Semi-Structured Interviews [Срок оценки: Post-Program (within 4 weeks of completion)]
Change in Physical Function and Performance (PSFS) [Срок оценки: Baseline (Week 0) to Post-Program (Week 12)]
Change in Sleep Duration [Срок оценки: Pre-Program (T-4 weeks), Program Start (Week 0), and Post-Program (Week 12)]
Change in Sleep Efficiency [Срок оценки: Pre-Program (T-4 weeks), Program Start (Week 0), and Post-Program (Week 12)]
Change in Resting Heart Rate [Срок оценки: Pre-Program (T-4 weeks), Program Start (Week 0), and Post-Program (Week 12)]
Change in Physical Activity Level [Срок оценки: Pre-Program (T-4 weeks), Program Start (Week 0), and Post-Program (Week 12)]
Change in Insomnia Severity - Insomnia Severity Index (ISI) [Срок оценки: Baseline (Week 0) to Post-Program (Week 12)]
Change in HDL Cholesterol [Срок оценки: Baseline (Week 0) to Post-Program (Week 12)]

Критерии участия

Критерии включения

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.