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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorBaylor University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial population

The study population consists of U.S. military veterans and first responders who have participated in the Shields \& Stripes 12-week multidisciplinary wellness program. The program integrates occupational therapy, mental health, physical therapy, and nutrition services. All data analyzed will be collected post-program completion, making the study primarily retrospective.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

80 Participants
are grouped into 1 trial group
Group A: Shields & Stripes Program Participants

Trial outcomes

Primary outcomes

1

Change in Psychological Functioning Generalized Anxiety Disorder 7-item (GAD-7) scale

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

Time frame
Baseline (Week 0) to Post-Program (Week 12)
2

Change in Psychological Functioning utilizing Patient Health Questionnaire-9 (PHQ-9)

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

Time frame
Baseline (Week 0) to Post-Program (Week 12)
3

Change in Psychological Functioning utilizing the Posttraumatic Stress Disorder Checklist (PCL-5)

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

Time frame
Baseline (Week 0) to Post-Program (Week 12)

Secondary outcomes

1

Change in Heart Rate Variability (HRV)

Change in heart rate variability as measured by the Oura Ring wearable device. HRV will be reported as the nightly average root mean square of successive differences (RMSSD). Time Frame: Pre-Program (T-4 weeks), Program Start (Week 0), and Post-Program (Week 12) Unit of Measure: Milliseconds (ms) Directionality: Higher values indicate better autonomic nervous system balance and recovery.

Time frame
Pre-Program (T-4 weeks), Program Start (Week 0), and Post-Program (Week 12)
2

Change in Sleep Quality - Pittsburgh Sleep Quality Index (PSQI)

Change in sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI), a validated 19-item self-report questionnaire assessing sleep quality and disturbances over the past month. Time Frame: Baseline (Week 0) to Post-Program (Week 12) Unit of Measure: Total PSQI global score (range: 0 to 21) Directionality: Higher scores indicate worse sleep quality.

Time frame
Baseline (Week 0) to Post-Program (Week 12)
3

Change in Health-Related Quality of Life - RAND 36-Item Health Survey (RAND-36)

Change in health-related quality of life as measured by the RAND 36-Item Health Survey (RAND-36), a validated self-report questionnaire assessing eight domains including physical functioning, role limitations (physical and emotional), energy/fatigue, emotional well-being, social functioning, pain, and general health perceptions. Time Frame: Baseline (Week 0) to Post-Program (Week 12) Unit of Measure: RAND-36 subscale scores transformed to a 0-100 scale. Directionality: Higher scores indicate better health-related quality of life and functioning.

Time frame
Baseline (Week 0) to Post-Program (Week 12)
4

Change in Total Cholesterol

Change in total cholesterol measured via standard laboratory testing. Unit of Measure: mg/dL Directionality: Lower values indicate improved lipid profile.

Time frame
Baseline (Week 0) to Post-Program (Week 12)

Other outcomes

Sponsors and contacts

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