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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a 10-week coping skills program for Hispanic/Latinx military patients with type 2 diabetes. It includes 7 video lessons with a health coach who speaks English and Spanish. The study compares the program with usual care to see how physical and mental health change over 6 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 18 to 70 years old.
  • Have type 2 diabetes.
  • Have an HbA1c of 7% or higher from a test in the past 6 months. This test measures average blood sugar. You may take diabetes pills or injections.
  • Have survey scores showing that you avoid dealing with diabetes-related problems or have trouble with diabetes self-care.
  • Describe yourself as Hispanic, Latino, Latina, or Latinx.
  • Prefer to use English or Spanish.
  • Receive care at the clinic where the study takes place.

Who can't join

  • Have kidney failure and receive dialysis, a treatment that filters your blood.
  • Have a health condition or life situation that makes taking part unsuitable.
  • Have advanced diabetes-related eye damage that prevents you from taking part.
  • Cannot read or understand the information for agreeing to join the study or the study instructions.
  • Are pregnant or plan to become pregnant in the next 6 months.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

TX