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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBaylor College of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acceptance Based Coping (ABaCo) Skills Program

    Behavioral

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Acceptance Based Coping (ABaCo) Skills ProgramExperimental treatment 1 intervention
Group B: Diabetes Treatment as Usual (DTAU)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

PROMIS Global-10

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

Time frame
Baseline, 6 weeks, 10 weeks, 24 weeks
2

Hba1c (Glycated hemoglobin)

Average blood glucose levels in past 3 months; higher percentages reflect higher levels (worse glycemic control).

Time frame
Baseline, 24 weeks

Secondary outcomes

1

Diabetes Distress Scale

17 Likert-type scale validated in English and Spanish; diabetes-related distress with subscales Emotional Burden, Physician Distress, Regimen Distress, Interpersonal Distress

Time frame
Baseline, 6 weeks, 10 weeks, 24 weeks
2

Summary of Diabetes Self-Care Activities

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.

Time frame
Baseline, 6 weeks, 10 weeks, 24 weeks
3

Acceptance & Action Diabetes Questionnaire

11 Likert-type items (10 in Spanish), validated in English and Spanish: acceptance of distressing diabetes thoughts/feelings and their interference.

Time frame
Baseline, 6 weeks, 10 weeks, 24 weeks

Other outcomes

1

Acceptability of the intervention: participant interviews & satisfaction ratings

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

Time frame
10 weeks (post-intervention)

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Baylor College of Medicine

Lead sponsor

American Diabetes Association

Collaborator

Henry M. Jackson Foundation for the Advancement of Military Medicine

Collaborator

Brooke Army Medical Center

Collaborator

59th Medical Wing

Collaborator

This trial is not recruiting at the moment. You can still explore other options: