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Supporting Access for Latinx Underserved in Diabetes Management (SALUD-M): Acceptance Based Coping Skills for Hispanic/Latinx Military Patients With Type 2 Diabetes (SALUD-M)

23. června 2026 aktualizováno: Kathryn E. Kanzler, Baylor College of Medicine

Supporting Access for Latinx Underserved in Diabetes Management (SALUD-M): An Equity-Driven Study of Acceptance Based Coping Skills for Hispanic/Latinx Military Patients With Type 2 Diabetes Mellitus

People of Hispanic or Latino/a/x ("H/L") ethnicity, including US military servicemembers, Veterans, and their families, experience a higher prevalence of type 2 diabetes and more challenges managing diabetes than non-Hispanic White populations. Uncontrolled diabetes is linked with lower quality of life, diabetes-related emotional distress, and severe medical problems. There are many reasons for this difference, including lack of culturally appropriate and bilingual Spanish healthcare services. Additionally, military patients may have additional barrier accessing behavioral health care, which an important part of treatment for many people with diabetes, such as stigma and unique schedule challenges.

Therefore, this study aims to overcome these barriers and improve healthcare and health outcomes for H/L military patients. We will test a values-based behavior change program, delivered using video telehealth by a bilingual English-Spanish language health coach. The 10-week Acceptance Based Coping (ABaCo) skills program includes 7 virtually-delivered lessons and was developed by the study team in partnership with civilian community health workers and patients. This study will test the helpfulness of ABaCo delivered by a health coach fluent in English and Spanish to military H/L patients. This randomized controlled trial will examine changes in physical and mental health over 6 months for those who receive ABaCo, compared to those who receive usual healthcare. This project will also identify steps for implementing the ABaCo program in other military treatment facilities.

The ultimate goal of this study is to establish a helpful, easy-to-access, widely available program for H/L military patients with type 2 diabetes that improves quality of life and blood sugar control, and lowers distress about diabetes. This study will also identify best approaches to providing ABaCo in military treatment facilities, providing lessons learned to other large healthcare systems.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

Hispanic/Latino/a/x ("H/L") populations, including US military and Veteran patients, experience a higher prevalence of type 2 diabetes mellitus (T2DM) and more challenges with glycemic control than non-Hispanic White populations. Poor glycemic control is linked with lower quality of life, diabetes-related distress and devastating medical complications. Contributors to this health disparity are multifaceted and include a lack of culturally appropriate and language-concordant healthcare. Additionally, in military populations, significant schedule demands and stigma about behavioral health care and may preclude optimal diabetes treatment.

This application proposes to address these barriers by testing a values-based behavior change program, delivered by a bilingual English-Spanish health coach, to enhance diabetes care for H/L military patients. The 10-week Acceptance Based Coping (ABaCo) skills program includes 7 virtually-delivered lessons and was developed by the study team in partnership with civilian community health workers and patients and could improve care for H/L military patients with T2DM.

The study aims are to: (1) Examine the effectiveness of ABaCo delivered by a health coach to military H/L patients through a randomized controlled trial and (2) Identify barriers and facilitators to implementation at the patient and clinic levels and assess the acceptability and feasibility of implementing ABaCo in a military treatment facility.

If successful, this study will establish an accessible and effective self-management-enhancement program that improves quality of life, psychological health and glycemic control for H/L military patients with T2DM; and identify implementation factors informing future scalability and sustainability of ABaCo at military treatment facilities.

Typ studie

Intervenční

Zápis (Odhadovaný)

100

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

(a) Patients ages 18-70, (b) diagnosis of T2DM, (c) current HbA1c (drawn within 6 months) of 7.5% or greater (may be taking oral agents or injectables for diabetes control), (d) evidence of avoidance coping (score <48.4 [published mean] on the Acceptance and Action Diabetes Questionnaire16) or poor self-management skills (score < published mean on 2+ subscales of the Summary of Diabetes Self-Care, Activities37), (e) self-described as Hispanic/Latino/Latina/Latinx, (f) preferred language of English or Spanish, (g) receiving care at the study site clinic.

Exclusion Criteria:

(a) End-stage renal disease (on dialysis), (b) a medical condition or life circumstance that would contraindicate participation, (c) proliferative diabetic retinopathy precluding participation, (d) inability to read/comprehend the informed consent process or study instructions, (e) pregnant or planning to become pregnant in the next 6 months.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Výzkum zdravotnických služeb
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Acceptance Based Coping (ABaCo) Skills Program

Participants randomized to the active intervention will undergo individual virtual classes once a week for 6 weeks (~30mins), a booster (review) class at week 10, and one follow-up class at 6 months post enrollment, for a total of 7 virtual calls. These virtual visits will be with a health coach trained and supervised in providing the ABaCo skills training program. All participants will continue to receive DTAU through the military healthcare system.

ABaCo Weekly Topic Overview:

Week 1:Understanding avoidance coping; identifying valued life areas Week 2: Building social support; using assertive communication Week 3: Accepting difficult thoughts & feelings; making meaningful choices Week 4: Noticing & letting go of unhealthy patterns; developing new life stories Week 5: Connecting to what matters in the present; committing to values Week 6: Reinforcing changes
Behaviorální: Acceptance Based Coping (ABaCo) Skills Program
The ABaCo program is a brief, bilingual and culturally appropriate educational program delivered virtually, based on the principles of Focused Acceptance and Commitment Therapy (ACT). ACT, a type of behavior therapy, empowers patients to engage in values-consistent activities, even in the context of great distress or adversity. ACT facilitates behavior change and good health outcomes by focusing on patient values and targeting avoidance coping (i.e., "experiential avoidance"). Thus, the ABaCo program was designed to help patients increase acceptance of difficult thoughts, feelings and experiences (e.g., cravings, diabetes-related distress, etc), ultimately helping them to care for their diabetes in a personally meaningful way, aligned with their valued life areas. ABaCo is delivered virtually over 6 consecutive weeks (1hr/each lesson) with a booster lesson at week 10.
Ostatní jména:
  • ABaCo
  • ABaCo+DTAU
Žádný zásah: Diabetes Treatment as Usual (DTAU)
Participants randomized into the diabetes treatment as usual (DTAU) control condition will continue to receive DTAU in the military healthcare system.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
PROMIS Global-10
Časové okno: Baseline, 6 weeks, 10 weeks, 24 weeks
10 Likert-scale items validated in English and Spanish, assess Physical and Mental health quality of life, including functioning, emotional distress, interference, overall quality of life, from Excellent to Poor
Baseline, 6 weeks, 10 weeks, 24 weeks
Hba1c (Glycated hemoglobin)
Časové okno: Baseline, 24 weeks
Average blood glucose levels in past 3 months; higher percentages reflect higher levels (worse glycemic control).
Baseline, 24 weeks

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Diabetes Distress Scale
Časové okno: Baseline, 6 weeks, 10 weeks, 24 weeks
17 Likert-type scale validated in English and Spanish; diabetes-related distress with subscales Emotional Burden, Physician Distress, Regimen Distress, Interpersonal Distress
Baseline, 6 weeks, 10 weeks, 24 weeks
Summary of Diabetes Self-Care Activities
Časové okno: Baseline, 6 weeks, 10 weeks, 24 weeks
12-item Likert-type scale validated in English and Spanish, measuring engagement in recent self-care activities: medication adherence, glucose testing, diet, exercise, foot care, smoking, and general diabetes self-care. The SDSCA can be scored multiple ways; we developed a composite score representing engagement in self-care activities over the past 7 days.
Baseline, 6 weeks, 10 weeks, 24 weeks
Acceptance & Action Diabetes Questionnaire
Časové okno: Baseline, 6 weeks, 10 weeks, 24 weeks
11 Likert-type items (10 in Spanish), validated in English and Spanish: acceptance of distressing diabetes thoughts/feelings and their interference.
Baseline, 6 weeks, 10 weeks, 24 weeks

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Acceptability of the intervention: participant interviews & satisfaction ratings
Časové okno: 10 weeks (post-intervention)
Semistructured interviews include 3 Likert-type scale items previously used by research team to assess participant satisfaction: ease of learning; overall satisfaction; likely to recommend
10 weeks (post-intervention)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Baylor College of Medicine

Spolupracovníci

59th Medical Wing
American Diabetes Association
Brooke Army Medical Center
Henry M. Jackson Foundation for the Advancement of Military Medicine

Vyšetřovatelé

  • Vrchní vyšetřovatel: Kathryn E Kanzler, PsyD, Baylor College of Medicine

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

15. června 2026

Primární dokončení (Odhadovaný)

1. března 2027

Dokončení studie (Odhadovaný)

30. června 2027

Termíny zápisu do studia

První předloženo

23. června 2026

První předloženo, které splnilo kritéria kontroly kvality

23. června 2026

První zveřejněno (Aktuální)

29. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

29. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

23. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • K08012023KH
  • 7-23-ICTSBMH-0 (Jiné číslo grantu/financování: American Diabetes Association)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NEROZHODNÝ

Popis plánu IPD

Details of sharing are not yet finalized. However, based on ethical considerations, the following data produced during the project will be preserved with the intention of sharing with appropriate requestors: deidentified standardized survey data; clinical data (i.e., demographics, lab values); quantitative implementation data (e.g., counts for recruitment, retention, referrals) qualitative data (aggregated matrix of interview responses by participants and clinicians/ administrators). To facilitate the interpretation of the data, metadata, including protocols and public data collection instruments, will be shared and associated with the relevant datasets.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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