Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 7-23-ICTSBMH-0 | Other Grant/Funding Number | American Diabetes Association |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| American Diabetes Association | OTHER |
| Henry M. Jackson Foundation for the Advancement of Military Medicine | OTHER |
| Brooke Army Medical Center | FED |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acceptance Based Coping (ABaCo) Skills Program | Experimental | 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 |
|
| Diabetes Treatment as Usual (DTAU) | No Intervention | Participants randomized into the diabetes treatment as usual (DTAU) control condition will continue to receive DTAU in the military healthcare system. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System Global Health 10 (PROMIS Global-10) | 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 |
| Hba1c (Glycated hemoglobin) | Average blood glucose levels in past 3 months; higher percentages reflect higher levels (worse glycemic control). | Baseline, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of the intervention: participant interviews & satisfaction ratings | 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) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amanda Leal | Contact | 240-673-8951 | amanada.leal3.ctr@health.mil |
| Name | Affiliation | Role |
|---|---|---|
| Kathryn E Kanzler, PsyD | Baylor College of Medicine | Principal Investigator |
Not provided
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.
Data will be available beginning 3 months and ending 5 years after publication of the primary outcomes.
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.
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| 59th Medical Wing |
| FED |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 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; 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 | 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 |
| Self-Compassion Scale - Short Form | 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) | 3-item Likert scale measuring loneliness; scores range from 3-9, with higher scores indicating greater loneliness. | Baseline, 6 weeks, 10 weeks, 6 months |
| D004700 | Endocrine System Diseases |