- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07674628
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)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Amanda Leal
- Phone Number: 240-673-8951
- Email: amanada.leal3.ctr@health.mil
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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 |
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.
Other Names:
|
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PROMIS Global-10
Time Frame: 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)
Time Frame: Baseline, 24 weeks
|
Average blood glucose levels in past 3 months; higher percentages reflect higher levels (worse glycemic control).
|
Baseline, 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diabetes Distress Scale
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability of the intervention: participant interviews & satisfaction ratings
Time Frame: 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)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kathryn E Kanzler, PsyD, Baylor College of Medicine
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- K08012023KH
- 7-23-ICTSBMH-0 (Other Grant/Funding Number: American Diabetes Association)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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