Improving Detection and Evidence-based Care of NAFLD in Latinx and Black Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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The primary objective of this pilot study is to assess the feasibility and acceptability of an intervention for improved detection and evidence-based care of NAFLD in Latinx and Black patients with type 2 diabetes (T2D) in Duke University Healthcare system (DUHS). We will enroll 10-15 Latinx and 10-15 Black patients with T2D and NAFLD, based on having mildly elevated liver enzymes (ALT >/= 40 IU/mL in males, ALT >/= 31 IU/mL in females) and exclusion of other liver diseases (e.g., viral hepatitis, alcohol abuse). Intervention content will include: 1) NAFLD education; 2)diet/lifestyle support; 3) T2D medication management; and 4) clinically-indicated liver testing and care. Intervention feasibility will be evaluated by examining recruitment rates, retention rates, and study visit completion rates. Acceptability will be assessed by survey and through qualitative interviews. The project objectives and intervention are minimal risk. The expected risks will not exceed those of usual care.

Official Title
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Improving Detection and Evidence-based Care of NAFLD in Latinx and Black Patients With Type 2 Diabetes (NAFLD-DM): A Pilot Study

Conditions
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NAFLD, Diabetes Mellitus

Intervention / Treatment
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* Behavioral: NAFLD Education
* Behavioral: diet/lifestyle support
* Drug: T2D medication management
* Diagnostic Test: clinically-indicated liver testing and care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: People who identify as either: Latino/Latina/Hispanic ethnicity and/or Black or African American race People with type 2 diabetes (T2D), as defined by ICD-10 codes E11.xx. Patients with elevated serum alanine aminotransferase (ALT) within Duke University Healthcare System (DUHS). Elevated ALT will be defined as having at least two ALT ≥40 IU/mL in males or ≥31 IU/mL in females in the preceding 12 months Exclusion Criteria: People with hepatitis B or C infection People with known alcohol overuse People with current use of chemotherapy or other drugs known to affect liver function People who have not been seen by a DUHS Primary Care Physician (PCP) or Endocrinologist in the preceding year.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evidence-based care of NAFLD in T2D<br>Intervention content will include: 1) NAFLD education; 2) diet/lifestyle support; 3) T2D medication management; and 4) clinically-indicated liver testing and care | Behavioral: NAFLD Education<br>* NAFLD Education<br>Behavioral: diet/lifestyle support<br>* diet/lifestyle support<br>Drug: T2D medication management<br>* T2D medication management<br>Diagnostic Test: clinically-indicated liver testing and care<br>* clinically-indicated liver testing and care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility as measured by recruitment rate | We will assess recruitment rates: Patients eligible and sent letter of message / Patients enrolled | 3months | 
| Feasibility as measured by retention rate | We will assess retention rates: Patients enrolled / Patients completing study | 3months | 
| Feasibility as measured by visit completion rate | We will assess visit completion rates: Total study visits completed / Total study visits scheduled | 3months | 
| Feasibility of system-level NAFLD detection approach | Patients who met criteria for NAFLD after chart review / total number of potentially-eligible patients based on our EHR criteria. We will deem this approach feasible if detection rates are >70%. | Baseline | 
| Acceptability of intervention by participants | We will calculate the mean and standard deviation of the Treatment Acceptability and Preferences (TAP);Minimum value = 0; Maximum value = 4; Higher score is a better outcome (ie more acceptable). We will define acceptable score as mean TAP ≥ 3. | 3months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Self-Efficacy measured by the Managing Chronic Diseases (SEMCD) score | The SEMCD is a 6-item scale with a minimum value = 1; Maximum value = 10; Higher score is a better outcome (ie greater self-efficacy) Maximum value = 60, Higher score is a better outcome (ie greater self-efficacy). Will be measured by a change of >/=1. | Baseline, 3months | 
| Change in Self-Efficacy measured by the Modified Health care Climate Questionnaire (HCCQ) | The HCCQ is a 5-item scale with a minimum value = 1; Maximum value = 5; Higher score is a better outcome (ie greater self-management) Will be measured by a change of >/=1 as being clinically significant. | Baseline, 3months | 
| Change in Quality of Living as measured by the SF-12 | The SF-12 is a 5-item scale with a minimum value = 0; Maximum value = 100; Higher score is a better outcome (ie greater quality of life) Will be measured by a change of >/=10 as being clinically significant. | Baseline, 3months | 
| Change in mean hemoglobin A1c (HbA1c) | Change of >/= 0.5% will be deemed clinically significant | Baseline, 3months | 
| Change in mean alanine aminotransferase (ALT) level | Change of >/= 5 IU/mL will be deemed clinically significant. | Baseline, 3months | 
| Change in medication adherence | Change as measured by the Voils Non-adherence measure. Minimum value = 0; maximum value = 5. Higher score is worse outcome (ie more non-adherence). Will be measured by change of >/= 1. | Baseline, 3months |