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

7. Juli 2026 aktualisiert von: 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. The investigators 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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 study will 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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

100

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • Patients ages 18-70
  • Diagnosis of T2DM
  • Current HbA1c (drawn within 6 months) of 7% or greater (may be taking oral agents or injectables for diabetes control)
  • Evidence of avoidance coping (score <48.4 [published mean] on the Acceptance and Action Diabetes Questionnaire) or poor self-management skills (score < published mean on 2+ subscales of the Summary of Diabetes Self-Care, Activities)
  • Self-described as Hispanic/Latino/Latina/Latinx
  • Preferred language of English or Spanish, (g) receiving care at the study site clinic.

Exclusion Criteria:

  • End-stage renal disease (on dialysis)
  • A medical condition or life circumstance that would contraindicate participation
  • Proliferative diabetic retinopathy precluding participation
  • Inability to read/comprehend the informed consent process or study instructions
  • Pregnant or planning to become pregnant in the next 6 months.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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
Verhalten: 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.
Andere Namen:
  • ABaCo
  • ABaCo+DTAU
Kein Eingriff: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Hba1c (Glycated hemoglobin)
Zeitfenster: Baseline, 24 weeks
Average blood glucose levels in past 3 months; higher percentages reflect higher levels (worse glycemic control).
Baseline, 24 weeks
Patient-Reported Outcomes Measurement Information System Global Health 10 (PROMIS Global-10)
Zeitfenster: Baseline, 6 weeks, 10 weeks, 24 weeks
10 Likert-scale items validated in English and Spanish assess global health-related quality of life in two areas: Physical and Global Mental Health, including functioning, emotional distress, interference, and overall quality of life, from Excellent to Poor. Scores range from 4-20 and are typically converted to T-scores; higher scores represent better health related quality of life.
Baseline, 6 weeks, 10 weeks, 24 weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Diabetes Distress Scale
Zeitfenster: 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. The final score and subscale scores are calculated as averages (means) ranging from 1-6; higher scores indicate greater diabetes distress.
Baseline, 6 weeks, 10 weeks, 24 weeks
Summary of Diabetes Self-Care Activities
Zeitfenster: 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; study investigators developed a composite score representing engagement in self-care activities over the past 7 days. Scores are averaged and range from 0 to 7; higher scores indicate a greater frequency of engagement in self-care activities.
Baseline, 6 weeks, 10 weeks, 24 weeks
Acceptance & Action Diabetes Questionnaire
Zeitfenster: Baseline, 6 weeks, 10 weeks, 24 weeks
11 Likert-type items (10 in Spanish), validated in English and Spanish, assess acceptance of distressing diabetes thoughts/feelings and their interference. Scores range from 11 to 55, with higher scores indicating poorer diabetes acceptance/greater experiential diabetes-related avoidance.
Baseline, 6 weeks, 10 weeks, 24 weeks

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Acceptability of the intervention: participant interviews & satisfaction ratings
Zeitfenster: 10 weeks (post-intervention)
Semistructured interviews include 3 Likert-type scale items previously used by the research team to assess participant satisfaction: ease of learning, overall satisfaction, and likelihood of recommending. Scores range from 0-10 with higher scores indicating greater acceptability.
10 weeks (post-intervention)
Self-Compassion Scale - Short Form
Zeitfenster: Baseline, 6 weeks, 10 weeks, 6 months
12 Likert scale items assess self-compassion with scores ranging from 12-60; higher scores represent greater self-compassion.
Baseline, 6 weeks, 10 weeks, 6 months
Three-Item Loneliness Scale (UCLA-3)
Zeitfenster: Baseline, 6 weeks, 10 weeks, 6 months
3-item Likert scale measuring loneliness; scores range from 3-9, with higher scores indicating greater loneliness.
Baseline, 6 weeks, 10 weeks, 6 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Baylor College of Medicine

Mitarbeiter

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

Ermittler

  • Hauptermittler: Kathryn E Kanzler, PsyD, Baylor College of Medicine

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. Juli 2026

Primärer Abschluss (Geschätzt)

1. März 2027

Studienabschluss (Geschätzt)

30. Juni 2027

Studienanmeldedaten

Zuerst eingereicht

23. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. Juni 2026

Zuerst gepostet (Tatsächlich)

29. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • K08012023KH
  • 7-23-ICTSBMH-0 (Andere Zuschuss-/Finanzierungsnummer: American Diabetes Association)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Based on ethical considerations, the de-identified data produced during the project will be preserved with the intention of sharing with appropriate requestors: 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). Any information that is published, reported, or otherwise released will be in aggregate/summary form and will not contain any personal identifiers. None of the 18 HIPAA identifiers will be released. To facilitate the interpretation of the data, metadata, including protocols and public data collection instruments, will be shared and associated with the relevant datasets.

IPD-Sharing-Zeitrahmen

Data will be available beginning 3 months and ending 5 years after publication of the primary outcomes.

IPD-Sharing-Zugriffskriterien

Study sponsors, study personnel and collaborators, as well as external researchers who provide a methodologically sound proposal with analyses that achieve the aims in the approved proposal.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • ICF

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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