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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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 pr

Первичные конечные точки

• Patient-Reported Outcomes Measurement Information System Global Health 10 (PROMIS Global-10) [Срок оценки: Baseline, 6 weeks, 10 weeks, 24 weeks]
• Hba1c (Glycated hemoglobin) [Срок оценки: Baseline, 24 weeks]

Вторичные конечные точки (3)

• Diabetes Distress Scale [Срок оценки: Baseline, 6 weeks, 10 weeks, 24 weeks]
• Summary of Diabetes Self-Care Activities [Срок оценки: Baseline, 6 weeks, 10 weeks, 24 weeks]
• Acceptance & Action Diabetes Questionnaire [Срок оценки: Baseline, 6 weeks, 10 weeks, 24 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Brooke Army Medical Center — San Antonio

Идентификаторы

NCT: NCT07674628 · K08012023KH · 7-23-ICTSBMH-0

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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