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

Duke University10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

NAFLD Diabetes Mellitus

Interventions

NAFLD EducationBEHAVIORAL

NAFLD Education

diet/lifestyle supportBEHAVIORAL

diet/lifestyle support

T2D medication managementDRUG

T2D medication management

clinically-indicated liver testing and careDIAGNOSTIC_TEST

clinically-indicated liver testing and care

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Duke University Healthcare System

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Feasibility as Measured by Recruitment Rate

The Investigator will assess recruitment rates: Patients eligible and sent letter of message / Patients enrolled

Time frame: 3 months

Feasibility as Measured by Retention Rate

The team will assess retention rates: Patients enrolled / Patients completing study

Time frame: 3months

Feasibility as Measured by Visit Completion Rate

The Investigator assess visit completion rates: Total study visits completed / Total study visits scheduled

Time frame: 3months

Feasibility of System-level NAFLD Detection Approach

Measure by the number of patients who met criteria for NAFLD after chart review / total number of potentially-eligible patients based on our EHR criteria.

Time frame: Baseline

Acceptability of Intervention by Participants

The Investigator 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). The Investigator define acceptable score as mean TAP ≥ 3.

Time frame: 3months

Secondary Outcomes

Change in Self-Efficacy Measured by the Managing Chronic Diseases (SEMCD) Score

The SEMCD is a 6-item scale with a total minimum value = 1; a total maximum value = 10; Higher score is a better outcome (ie greater self-efficacy). Will be measured by a change of \>/=1.

Time frame: Baseline, 3months

Change in Autonomy Support Measured by the Modified Health Care Climate Questionnaire (HCCQ)

The HCCQ is a 5-item scale with a total minimum value = 1; a total 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.

Time frame: Baseline, 3months

Change in Physical Health Quality of Living as Measured by the 12-Item Short Form Health Survey (SF-12)

The SF-12 is a 5-item scale with a total minimum value = 0; a total 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.

Time frame: Baseline, 3months

Change in Mental Health Quality of Living as Measured by the SF-12

Time frame: Baseline, 3months

Change in Mean Hemoglobin A1c (HbA1c)

Change of \>/= 0.5% will be deemed clinically significant

Time frame: Baseline, 3months

Change in Mean Alanine Aminotransferase (ALT) Level

Change of \>/= 5 IU/mL will be deemed clinically significant.

Time frame: Baseline, 3months

Number of Participants With Changes to Medications During the Study Period Measured by Chart Review

Time frame: baseline, 3 months

Number of Participants in Whom Clinically-indicated Tests Were Ordered (e.g. Labs, Referral, Imaging).

Time frame: baseline, 3 months

Data from ClinicalTrials.gov

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